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Video tags
Subtitles
Russian
00:00:01
[music]00:00:26
minus specialists inspection department00:00:29
produce and medicines00:00:31
little state power00:00:33
relevant practices 200200:00:36
I'm here to talk to the inspection team00:00:37
place that is inserted00:00:39
inspection of foreign00:00:40
drug manufacturers00:00:42
compliance with regulations00:00:43
good manufacturing practices for00:00:46
I am a biotechnologist by education and place of work00:00:49
for the production of sterile non-sterile00:00:50
medicines and today my00:00:53
the presentation will focus on questions00:00:54
maintaining proper production00:00:57
Practitioner regarding alignment yes00:00:59
the topic is quite extensive, so we00:01:02
we will stick to the following plan00:01:05
Let's review the principles of integrity00:01:07
data and will show it inside the boot, we’ll discuss it00:01:10
expectations regarding paper recordings00:01:12
media in relation to electronic recording00:01:14
we'll talk about support00:01:16
data alignment of such scorpion tons00:01:18
culture of staff behavior and00:01:20
applying a risk-based approach00:01:22
to data management we will00:01:25
a management model from00:01:27
comments delivered out of shame00:01:28
technical report ideas after which we00:01:31
Let's discuss the life cycle in lido slightly00:01:34
motorized systems and00:01:35
We also provide the relevant documentation00:01:38
let's review just one hundred00:01:39
applications with the same not Russian advice00:01:42
economic commission but what not00:01:44
We will discuss working with electronic data00:01:46
table with data in the quality control department00:01:49
using the example when logical00:01:50
physico-chemical bathory and conclusion00:01:53
Let's consider, for example, potential00:01:55
linked data problems in production00:01:58
I would like to start with lists of any00:02:01
paired requirements and guidelines which00:02:02
need to know a production employee00:02:04
not all of these sites are possible00:02:07
you need to know the documents thoroughly00:02:09
because some of them talk about00:02:11
one and the same that but in principle for00:02:13
understand the requirements regarding the method00:02:15
hence the requirements for freeze-up and00:02:17
operation of compensated systems00:02:19
It is recommended to know what these documents are about00:02:21
like00:02:23
acceptance must be carried out when working with00:02:25
actual data in 2003 in the USA and00:02:29
on the day it was released updated and00:02:31
industry guide with recommendations00:02:33
in relation to electronic records or00:02:36
podcast scope of activity application00:02:38
2007 cooperation scheme in the field00:02:41
political inspections 5 places I released00:02:45
guidance on good practice for00:02:47
be backup systems in regulated00:02:49
in principle, the environments on target documents were00:02:51
provide reference recommendations00:02:53
information regarding politicized00:02:56
systems that will be useful to the spector00:02:58
training purposes and during active00:03:00
systems in European requirements Jane and00:03:04
Odessa was revised in 201100:03:06
computerized system application00:03:08
which had certain requirements in00:03:11
regarding operational validation00:03:13
preserved systems in Russia since 201300:03:16
year to act is an order00:03:19
The Ministry of Industry and Trade of Russia needs 916 which00:03:22
has the number one apps in antiquity00:03:24
number one app from Europe00:03:25
requirements further in 2016 there was a wife00:03:29
77 birth which also contains00:03:31
application number 11 is identical00:03:34
application number eleven of00:03:35
European requirements in addition to00:03:37
application number 11 also have00:03:42
documentation requirements and requirements in00:03:44
regarding operational validation clause00:03:47
backup systems and in production00:03:49
pharmaceutical substances00:03:52
employees of our institute were00:03:54
management and integrity developed00:03:56
data bond outline green systems00:03:58
which should be considered as00:04:00
means to understand the position00:04:02
Department of Development of Pharmaceutical and00:04:04
medical industry of the Ministry of Industry and Trade00:04:05
Russia and football dance in relation to00:04:09
consistency of data and minimum expectations00:04:13
achieving compliance00:04:15
requirement methods considered in this00:04:18
manual are given in accordance with00:04:20
expectations defined in00:04:21
relevant guidelines issued00:04:23
competent and wanderings for example00:04:25
world health organization00:04:28
sow s.p.00:04:30
British agency and mothers released00:04:33
201800:04:35
guidance and definition from shame00:04:37
in principle it is aimed at eliminating00:04:40
fundamental errors revealed by help00:04:42
their international partners00:04:44
regulation during processes in00:04:47
time for these checks jill pj jay00:04:50
Jay00:04:51
2018 in the USA per day was released00:04:55
Q&A guide00:04:57
related stealth here the purpose of this00:05:00
management had to clarify the role00:05:02
integrity to current proper00:05:04
industrial practice for00:05:05
medicines00:05:07
world health organization00:05:09
technical reports number a were issued00:05:12
996 is a guide to proper00:05:15
records data management practices and00:05:17
number 1025 good practice00:05:20
taking photographs00:05:22
2020 and at the end you see the project00:05:25
Pestle's Guide to Data Management00:05:28
misalignment resolved genie pdp environments00:05:35
common practice for most00:05:38
tourism enterprises is00:05:39
using the approaches described in00:05:42
industry guides that you00:05:43
you see on this slide these are00:05:46
organizations as an international association00:05:48
pharmaceutical engineering and00:05:50
Oral Parade Manufacturers Association00:05:52
medications frequently00:05:54
data integrity violations00:05:56
we discover and recent years have prompted00:05:58
any paired organs are given environment on00:06:00
priority during00:06:03
traditional checks and from employees00:06:04
after six Kanska pirates continues00:06:06
discover conditions and methods that00:06:09
endangered created among whom00:06:11
there are human errors00:06:13
inadequate supervision00:06:15
guidance I am not enough and training00:06:17
employees, system failures are not00:06:20
relevant qualifications00:06:22
system configurations are of poor quality00:06:24
procedures or observation sites procedure00:06:26
also falsification00:06:28
worldwide pharmaceutical industry00:06:31
is it a highly regulated industry or00:06:33
interaction between rival paired organs and00:06:35
acoustic companies for example when00:06:37
registration of medicines00:06:39
and during activities are associated with00:06:41
inspection of production sites00:06:43
are checked by regulatory authorities00:06:45
documents also include technical data00:06:48
shredded information or will receive but00:06:51
initial information must be00:06:54
third-party complete and reliable measurements00:06:57
control to ensure alignment00:06:58
data must be embedded in00:07:00
practical quality system which00:07:02
guarantees about medicines00:07:03
have the required quality00:07:06
data integrity applies to all00:07:09
elements of the prognostic system00:07:10
qualities and principles that will be below00:07:13
considered should be applied in00:07:14
respect00:07:15
paper records00:07:18
made using electronic00:07:19
systems throughout the life cycle00:07:22
data that covers all stages00:07:25
existence of tourism data00:07:26
companies must follow proper00:07:28
record keeping practices00:07:30
to develop a data control strategy00:07:33
production site is necessary00:07:34
use risk assessment and analysis00:07:37
process data integrity00:07:38
chromatic companies bear from for00:07:41
the electronic systems they use00:07:42
data generated by these systems for00:07:45
good practices regarding00:07:47
data integrity management00:07:49
includes data received within the framework of as a00:07:52
single and management activities00:07:54
companies are primarily responsible for00:07:56
resource allocation and implementation00:07:58
control measures aimed at seats00:08:01
minimum potential risks for00:08:03
data integrity and also for00:08:05
identification of residual risks key00:08:08
principles are like a piece of paper like this00:08:10
electronic document management combined00:08:12
in the acronym l sang and00:08:15
traceability readability00:08:16
timeliness in range and accuracy00:08:18
which was a rasp by adding others00:08:20
attribute completeness00:08:23
consistency stability and00:08:25
accessibility which is now called00:08:28
lcl and plus00:08:31
fulfillment of expectations l100 and plus which00:08:36
we will consider below guarantees that00:08:38
event properly00:08:39
documented and data can00:08:41
be used to make reasonable00:08:43
solutions on the next slides we are with you00:08:46
let's look at what they are00:08:47
given attributes and expectations regarding00:08:50
generated data00:08:53
trace00:08:54
the data must belong to the sheet00:08:56
who created the data based on importance00:08:59
data and should also be tracked yes00:09:02
device systems in which the data was00:09:04
generated recorded00:09:06
sender information for example00:09:08
operator systems of data senders and00:09:10
system such as devices or process00:09:13
must be stored as part of the method00:09:15
metadata is the data of the data00:09:18
structured the information that00:09:21
describes explain or otherwise00:09:24
makes it easier to receive00:09:26
use or management of data00:09:29
metadata for a specific piece of data00:09:31
can begin to self-date and time stamp00:09:34
documenting when the data was00:09:36
obtained from the user ID then00:09:39
there are persons conducting a test or analysis00:09:41
by generating this certificate00:09:44
tools used to collect00:09:47
data given state of material and .00:09:50
tion number of materials and control00:09:52
log and expectation regarding recording on00:09:55
paper media is the use00:09:58
employee ID for example00:10:00
initials00:10:01
complete with manual signature or personal00:10:04
print expectations regarding electronic00:10:06
stock up00:10:07
we use the system must be00:10:09
unique user accounts00:10:12
or electronic signature biometric00:10:15
line biometric audit trail00:10:17
audit auditor00:10:19
Well, the electronic signature is not biometric00:10:22
electronic signature this combination00:10:24
digital data with which you can00:10:26
identify the person00:10:28
biometric signature is when00:10:30
biometric feature of the signer00:10:32
saved on the system is average00:10:35
which characterizes physiological00:10:36
biological feature of a person and00:10:39
audit trail the auditor is00:10:42
secure computer generated00:10:44
electronic record with time stamp00:10:46
which allows you to reconstruct00:10:48
events related to creation changes00:10:51
or deleting an electronic record00:10:54
read data should be kept readable00:10:59
form so they can be viewed00:11:01
let's fill in the context therefore change00:11:03
data such as compress encryption and00:11:06
coding must be completely00:11:08
reversible so that we cut it off and preserve it00:11:10
data can be both static and00:11:12
dynamic static recording is00:11:15
We fix the document with data, for example00:11:18
paper record electronic image00:11:21
practically preventing interaction00:11:23
between the user's post content and00:11:25
chemical recording format for example00:11:28
electronic records that allow00:11:30
interactive communication between the user00:11:32
and the contents of records for example00:11:33
electronic records of chromatograms00:11:35
saved in electronic format00:11:37
allows user or verify00:11:39
to re-process00:11:41
data and zoom in to00:11:43
see the details more clearly00:11:46
data stability should be maintained00:11:49
properly so that they remain00:11:52
intact and durable00:11:54
life cycle depending on00:11:57
situations in accordance with regulations00:11:59
storage requirements00:12:02
Availability of data must be constant00:12:05
stored to be accessible to00:12:07
views if necessary waiting00:12:10
regarding paper recording00:12:12
should be used here00:12:14
indelible ink00:12:16
one-line drawing for writing00:12:18
do not change date name and reason entries00:12:22
corrective must be used00:12:23
liquid or other methods that can00:12:25
make it difficult to see the stock should00:12:27
controlled release of stitched00:12:29
notepad with branched pages of00:12:31
numbered sequentially00:12:32
pages must be controlled00:12:35
exhalation sequentially numbered00:12:37
copies of empty forms must be made and00:12:41
beliefs of paper documents and00:12:43
expectation regarding electronic stock00:12:46
content is important for dynamic data00:12:50
record values possibility00:12:52
interact with data using00:12:53
a suitable application should00:12:56
used protected control00:12:58
log and killed with time stamps00:12:59
which independently record actions00:13:01
users must be specific00:13:03
configuration parameters and standard00:13:05
operating procedure00:13:07
disable and disable capabilities00:13:09
overwriting data and tea talk and00:13:11
intermediate brother where00:13:13
strict control must be carried out00:13:15
configuration tool used00:13:18
annotate the data so that00:13:20
stop hiding display and00:13:22
printing data regularly should00:13:26
backup the recording00:13:28
to provide emergency00:13:30
recovery to create a copy of files and00:13:34
folders on additional media00:13:36
information such as external hard00:13:37
disk or regional storage and00:13:40
archive here or00:13:44
is the storage of electronic information in00:13:47
unchanged00:13:48
archiving is different from backup00:13:50
copying primarily because00:13:52
intended for long-term storage00:13:54
information and does not provide00:13:56
demand towards access when00:13:58
necessity00:14:01
timeliness of data must00:14:03
generated by the system or recorded00:14:06
information to the person during observation00:14:09
observation time constant time00:14:11
conservation should be about places as part00:14:14
metadata including audit trail00:14:15
audit00:14:17
accurate date and time information00:14:20
should automatically record00:14:23
linked and specified by external standards00:14:25
for example it could be the universal Venus00:14:27
during song or center time00:14:29
servers00:14:31
expectations regarding paper recordings00:14:33
media00:14:34
training procedures must be used00:14:37
reviews of algity itself inspections which00:14:40
ensures that staff take notes00:14:42
data and information during sleep00:14:44
peaches activity directly into00:14:46
official controlled documents00:14:48
the procedure must require that00:14:50
actions were recorded on paper00:14:52
media indicating validity dates00:14:57
Expectations regarding electronic records00:14:59
parameters must be used00:15:02
configurations standard rations and00:15:03
procedures that provide fixation00:15:06
electronic data on reliable media00:15:08
during actions and before moving on to00:15:10
next step for the event00:15:12
sequence of stages or events00:15:14
marking systems must be used00:15:17
dates and times that cannot be00:15:19
changed00:15:20
staff should be analysts00:15:22
procedures and service program00:15:25
provide date and time synchronization00:15:27
in all operations jack and00:15:30
controls allows you to place00:15:33
time of one action to another00:15:37
under00:15:38
data must be from us data00:15:41
first generation00:15:42
capture00:15:44
observation certified copies may00:15:46
replace original data information00:15:49
originally recorded dynamically00:15:50
condition should be simply accessible and in00:15:52
in this state00:15:53
completeness to restore completely00:15:57
understand to be given must be given in full00:15:59
presentation of the observation made00:16:01
must be presented in use00:16:03
context and associated metadata00:16:04
including the audit log data in00:16:08
which source text or data00:16:11
including the audit trail were lost00:16:13
are incomplete00:16:16
expectations regarding paper recordings00:16:19
media must be ensured00:16:21
staff conduct adequate00:16:23
verification and approval of similar paper00:16:25
documents including document00:16:27
used to record timely00:16:30
collecting information00:16:31
review procedures data should describe00:16:34
analysis of relevant metadata00:16:37
data review should be00:16:39
documented on paper00:16:41
usually means signing a record on00:16:44
papers that have been reviewed00:16:47
procedures must describe actions00:16:49
what needs to be done if00:16:50
data analysis reveals errors or00:16:53
put omissions with principles00:16:55
plus00:16:57
it is not possible to recreate the recording on00:16:59
paper of the named shapes00:17:04
relationship of expectation here in relation00:17:07
electronic records such that in principle00:17:10
they are similar and required here too00:17:14
ensuring staff00:17:16
adequate checks of institutions and00:17:18
bedroom electronic records including00:17:21
read the original electronic records00:17:23
data procedures review data should00:17:25
describe the analysis of controversial electronic00:17:27
data from such methods overview of data00:17:30
must be documented in00:17:32
electronic records are usually00:17:33
indicated by an electronic signature00:17:35
corrugated data set which I was00:17:38
reviewed waiting for procedures must00:17:40
describe the action that is needed00:17:41
undertake what if data analysis00:17:44
is or omission in accordance with00:17:47
principles and plus and00:17:51
electronic functionality00:17:53
control she low detail00:17:56
accuracy can be based on facts00:18:00
related to equipment such00:18:03
qualifications calibration00:18:06
maintenance and were available00:18:09
90 with watering and control procedure00:18:13
actions and behavior00:18:15
processes for assessing data for00:18:17
compliance with procedural requirements for00:18:20
deviation management including analysis 300:18:22
years reason for impact assessment and capa on00:18:26
trained and qualified personnel00:18:27
understand the importance of compliance00:18:29
established procedures and00:18:31
documentation in action matte00:18:35
use of computerized00:18:37
systems and must guarantee data00:18:38
will be at least as accurate00:18:40
like data recorded on paper00:18:42
media process of transferring data between systems00:18:45
rowan must be valid for the data00:18:47
data must remain accurate00:18:50
contain accurately reflects what has been done00:18:52
observation metadata must contain00:18:55
information to describe observations during00:18:57
if necessary they may also contain00:18:59
information confirming their accuracy on00:19:03
consistency is about what should00:19:06
create processes provide and00:19:09
uniformity of the definition of creation00:19:12
collection and management including migration00:19:16
data throughout life00:19:18
cycle these processes must be00:19:21
implemented in such a way that00:19:22
minimize the risk of contradiction00:19:24
for example through standardization00:19:26
data and training checks00:19:29
control measures must be followed00:19:33
caliber qualification and maintenance00:19:35
equipment00:19:36
carrying out printing00:19:38
activision validation of their systems validation00:19:42
production processes00:19:43
review record xp and investigation00:19:46
deviations00:19:49
slide 1800:19:53
data management is purchased00:19:56
organizational events00:19:57
ensuring data integrity on00:20:00
data management even for growth00:20:01
extend to data ownership and00:20:04
will suit us throughout00:20:06
life cycle and design00:20:10
process usage and monitoring00:20:12
system in accordance with the principles00:20:14
created including control with00:20:17
intentional and unintentional00:20:19
changes to00:20:21
effective data management system00:20:23
demonstrate understanding and commitment00:20:26
company management is reliable to practitioners00:20:28
data management including necessity00:20:29
combinations correspond to organizational00:20:31
staff culture and behavior and00:20:34
understanding of risk is related to data on00:20:37
throughout the life cycle00:20:40
data lifecycle extends00:20:42
then the data is submitted and processed00:20:45
reported checked used for00:20:49
decisions are kept permanently00:20:53
deleted at the end of saving00:20:55
data transfer can take between00:20:58
relatives and these systems or between00:21:01
across different organizational boundaries00:21:03
as internal for example between00:21:05
production quality control and00:21:07
quality assurance and external00:21:09
for example between service providers or00:21:12
contractors and customers00:21:14
data according to the recording method can be00:21:17
paper00:21:19
paper record observation whether00:21:21
manual activity data00:21:23
received manually on paper can00:21:25
require an independent review if00:21:27
it will be forgiven necessary according to00:21:30
data integrity risk assessment or00:21:32
as per requirement00:21:34
electronic electronic for seats00:21:37
obtained when used as00:21:39
simple and complex equipment00:21:42
politicized systems00:21:43
Are the trial systems simple and00:21:46
software setting and from electronic00:21:48
storing data such as your meters and00:21:50
scales and00:21:52
I will only require thermometers00:21:54
calibration and or verification at the same time00:21:58
difficult grain capture system requires00:22:00
validation00:22:02
data may be00:22:05
hybrid this record in which the original00:22:09
records are made both on paper and00:22:10
electronic recording when using00:22:13
hybrid systems must be clearly00:22:15
primary records are identified that00:22:17
must be reviewed and retained00:22:19
original post is00:22:22
data in the form of a file or formats in which00:22:24
they were originally created with00:22:27
maintaining integrity, for example00:22:29
original paper record received00:22:31
manually or electronically00:22:33
raw data from00:22:34
politicization of the system00:22:36
this data should allow full00:22:40
reconstruct activities leading00:22:42
to obtain data what is primary00:22:44
record primary record record which00:22:47
shall prevail in those00:22:48
cases where the data that is collected00:22:51
and are stored simultaneously00:22:53
more than one method does not match00:22:56
There are also00:22:57
this type of stuff00:23:00
this is such such such information00:23:05
how to such data as photographs on00:23:08
image and chromatographic00:23:10
plates if00:23:12
received data00:23:15
recorded using photography or00:23:17
image or other media then for00:23:20
choosing storage conditions for this format00:23:23
data throughout their life00:23:24
cycle follows guide00:23:26
was guided by the same considerations00:23:28
as for other data formats00:23:31
taking into account any additional elements00:23:35
regardless of the format, paper or00:23:38
electronic all data including00:23:40
raw data meta data should00:23:43
meet the l skill requirements00:23:44
plus00:23:46
information originally recorded as00:23:49
dynamic must remain00:23:50
available in this condition00:23:52
raw data should allow00:23:54
completely reconstruct the order00:23:56
actions taken00:23:59
data management policy is approved00:24:01
at the highest levels of the mystical00:24:03
the company's quality culture must be00:24:06
transparent and open in which staff and00:24:09
are encouraged to freely communicate their00:24:11
mistakes including social problems with00:24:13
reliability of the data so that you can00:24:15
was to carry out adjustments expect00:24:18
event00:24:20
management can stimulate culture00:24:22
quality through the creation of a code00:24:25
ethics and code of conduct00:24:28
leadership by example through00:24:30
which management should00:24:31
demonstrate the behavior that00:24:33
expects to see his subordinates00:24:37
ensuring accountability for action00:24:39
solutions for constant active participation00:24:42
setting realistic expectations00:24:44
taking into account the limitations that00:24:46
pressure on employees code of value00:24:49
because you have to reflect the salmon00:24:51
management through policies that00:24:53
complies with the quality culture and00:24:54
create an atmosphere of trust in which everyone00:24:57
employees are responsible for00:24:59
ensuring patient safety00:25:00
product quality policy code00:25:03
behavior must clearly define the norms00:25:05
ethical behavior such as00:25:07
tess it should be brought to 10000:25:10
units of all personnel00:25:11
ideas, a document was developed for the industry00:25:15
elements of a code of conduct regarding00:25:17
data alignment which can be00:25:20
used on company places beach issue00:25:23
medicines00:25:24
the entire staff of the mystical enterprise00:25:27
should be ordinary Sasov politicians00:25:30
data comply with it00:25:31
managers and employees of quality services00:25:34
must be trained in measures to00:25:35
violation prevention and detection00:25:37
suspicious data00:25:39
training must be provided upon admission00:25:42
work and regular through certain00:25:44
time intervals must be assessed00:25:45
learning efficiency00:25:48
application of modern principles00:25:50
risk management for quality and00:25:53
closest data management practice00:25:55
existing prognostic system00:25:57
quality serves to modernize the system00:26:00
quality in order to solve problems that00:26:02
do data generation occur?00:26:04
company chromatic quality system00:26:06
should provide appropriate00:26:08
controls on which are described in00:26:11
procedure which is aimed at00:26:13
maintaining cookie data integrity00:26:15
life cycles such as assessment and00:26:19
Management of risks00:26:21
investigation programs are aimed at00:26:23
when there is a violation of integrity00:26:25
data and00:26:27
or study of identified violations00:26:31
validation data review practice00:26:34
management software00:26:36
suppliers and contractors00:26:38
the training program is included when00:26:40
procedure data integrity policy00:26:42
on data integrity for inclusion in00:26:45
data accuracy self inspection program00:26:48
quality indicators and reporting to00:26:50
senior management00:26:53
on this slide you see00:26:56
responsibility of senior management and00:27:00
senior management's responsibilities include00:27:03
promotion and support of culture which00:27:07
maintains data integrity00:27:10
ensuring staff training in the principle00:27:12
data integrity and detection method00:27:14
data integrity problems00:27:17
management must create a working environment00:27:19
which allows you to see errors and00:27:21
omissions not and not these night results00:27:23
management should encourage00:27:25
transparent investigation and analysis and00:27:29
mechanisms must be installed00:27:31
guaranteeing that staff will not00:27:33
be subject to commercial political00:27:36
financially and on each other00:27:38
pressure or conflict of interest that00:27:40
may negatively affect the quality00:27:43
their work and from this data00:27:47
should conduct regular reviews00:27:50
quality indicators from the outside00:27:52
guidelines, including those related00:27:54
data integrity quality indicators00:27:57
should cover the following types00:27:58
action on preventive action is00:28:01
supervision of rules to prevent00:28:03
violations00:28:05
corrective is on the monitor00:28:07
compliance between execution and results00:28:10
running comparison with requirements and00:28:11
narrow plus and00:28:13
monitoring is quantity control00:28:15
actual violation of integrity and00:28:17
appropriate follow-up actions00:28:20
For00:28:23
periodic performance checks and00:28:26
control measures in relation to these00:28:27
indicators00:28:28
aimed at demonstrating00:28:30
commitment leadership assurance00:28:32
alignment of data management in the field00:28:34
jimmy key is it possible to attract independents00:28:36
experts00:28:39
the data may be different because not all00:28:42
data processing stages are the same00:28:45
implications for product quality and00:28:47
patient safety to determine00:28:50
the importance of each stage of data processing00:28:53
control must be used00:28:55
risks00:28:56
risk must be controlled independently00:28:59
from that they are controlled nearby using manual00:29:01
system or motivated electronic00:29:03
system any potential violation00:29:05
data integrity loss of pass00:29:09
deleting and changing data must be done once00:29:11
be required to be eliminated and taken into account00:29:13
quality system and reflected in00:29:16
risk management documentation00:29:18
The following factors are identified:00:29:20
data criticality and00:29:23
susceptibility to disruption00:29:27
there are three possible ways to carry out00:29:29
risk assessments are the first path from assessment00:29:32
risks must be carried out proactively in00:29:36
time to implement any news system00:29:38
data management and should00:29:40
fixed by change control 200:29:42
let when executed in existing00:29:44
assessment data management systems00:29:47
should identify potential vulnerabilities00:29:48
data based on existing level00:29:51
control and criticality of data for their00:29:54
intended use00:29:56
companies should also consider00:29:59
Possibility of risk assessment00:30:01
after a deviation or incident to00:30:04
identify potential gaps in the system00:30:06
data management and third key00:30:08
data integrity risk assessment also00:30:10
should be carried out in combination with00:30:12
system change management processes00:30:15
data management to avoid00:30:18
creating new or additional risks00:30:22
identify key attack targets00:30:25
is the root cause related to the gap00:30:27
manage yes and if yes then accepted00:30:30
degree of impact on data00:30:33
about mystical companies should00:30:35
develop and implement and operate00:30:38
documented system providing00:30:40
and acceptable state of control on00:30:42
risk-based approach to00:30:44
data integrity management00:30:46
appropriate justification00:30:48
an example of an acceptable approach is00:30:50
risk assessment of data equipment in which00:30:52
processes producing data or00:30:55
as a result of which the map data was obtained00:30:57
practically influences or spokes are removed00:31:00
ensures inherent risks are documented00:31:03
the risk assessment will then have to be exactly00:31:06
business process for example production00:31:09
quality control quality assurance00:31:12
data flows need to be assessed and00:31:15
methods for obtaining data they are simple00:31:17
learned functionality or complexity00:31:18
canned system in the stalls for00:31:21
considerations get themselves complicated00:31:24
process methods for generating storage and00:31:27
data deletion ability00:31:30
ensure accuracy and readability00:31:32
medal cost data sequence00:31:35
processes and degree of automation on00:31:38
human factor and cool kim out00:31:40
the result that is the process00:31:42
open or clearly defined00:31:44
result of data comparison00:31:46
electronic system and events00:31:49
registered manual understanding00:31:52
production process and processes00:31:54
data lifecycle is critical00:31:56
implications for developing successful00:31:58
risk management strategies00:32:02
data integrity control should be00:32:04
be treated as behavioral00:32:07
from a technical point of view00:32:09
behavior general culture quality00:32:11
including communication and learning closely00:32:14
is related to the effectiveness of its software00:32:16
ensuring data integrity when00:32:18
considering the influence of human00:32:20
behavior when studying elements00:32:22
posing a risk to data00:32:24
two categories need to be considered00:32:26
actions are unintentional and00:32:29
deliberate actions00:32:30
reasons for unintentional actions00:32:32
there may be a gap procedure for example00:32:36
due to poor detailing of the standard00:32:38
operating procedure procedure work00:32:40
with deviations mechanics make mistakes00:32:43
when registering deviations that00:32:45
occur during setup00:32:46
critical equipment gap in00:32:49
knowledge, for example, incorrect00:32:51
operation and registration at the same time00:32:54
data during critical operation00:32:55
equipment, for example, from 0 about because00:32:58
them actively conducted training00:32:59
operator00:33:01
lack of attention to examples from these00:33:04
taxes allowed in calculations00:33:06
protocols for the production of medicinal products00:33:07
drugs due to concomitant00:33:10
operation of several production lines00:33:12
lack of memory for examples of such00:33:15
controllers who carry out00:33:16
in-production control00:33:18
packaging lines is with untimely00:33:21
there must be appropriate00:33:24
procedures are required and documented00:33:26
investigation in case of any00:33:28
mishandling or misuse00:33:31
in the use of data that00:33:33
obtained as a result of such failures00:33:35
intentional actions00:33:36
investigation should reveal the main00:33:38
reason00:33:39
determine impact and criticality00:33:41
deviations and assign appropriate00:33:42
do you correct any warnings?00:33:44
actions00:33:45
if it is assumed or certain00:33:49
the cause of human error and and should00:33:51
justify by taking care not to00:33:54
lose sight of procedural00:33:56
possible procedural and system errors00:33:58
or problems if any00:34:03
reasons for intentional actions can00:34:05
be a scam for example yes a couple00:34:09
will be via electronic system00:34:11
factually unreliable and critical00:34:13
process parameters despite the fact that00:34:15
they differ from the specified allowed or00:34:19
misdemeanor e.g. data defecation00:34:21
microclimate parameters in refrigeration rooms00:34:23
cameras that are registered manually00:34:26
employees in operation logs00:34:29
many cameras employee maybe 100:34:32
what is important to understand here is not to know00:34:35
deliberate actions can be00:34:37
identified and investigated00:34:40
deliberate may be 9 office and00:34:43
Ravana and not investigated00:34:45
as we already said, that data is recorded in00:34:48
electronic and paper required00:34:50
risk management approaches to00:34:52
determine which control measures are important for00:34:55
ensuring alignment to evaluate00:34:58
level exposed to potential00:35:00
access problems for gypsies they need00:35:03
take into account the following elements00:35:05
data criticality00:35:08
current existing level trolls00:35:11
these but include you00:35:14
managing data when it is recorded00:35:17
manual automated processes00:35:19
human factor volume humanity00:35:22
enthusiastic intervention00:35:23
hand sculpted production process00:35:25
motivated and process jim and includes00:35:27
written training check procedures00:35:29
and so on thus criticality00:35:32
data and current data troll level00:35:35
taken together can help identify00:35:37
data vulnerability risk vulnerability00:35:40
data it can point to00:35:42
level of exposure problem00:35:45
data integrity for internal00:35:47
disadvantages of managing three parties have00:35:50
or elements of this collection technology00:35:52
data, that is, manage data00:35:54
human factor and00:35:56
production processes or combinations00:35:59
those three elements00:36:00
pictured in stock control model00:36:03
data integrity risks00:36:05
provides for the construction of a map00:36:07
data vulnerability and depending on00:36:09
zones that the data falls into or00:36:12
control strategy is determined or00:36:14
I guarantee the current level of control00:36:16
that unintentional problems with shame00:36:18
unlikely let's look at what00:36:21
there may be a classification of criticality00:36:24
for a long time00:36:25
it can be critical when the east00:36:27
intended use of the data00:36:29
directly affects the quality of the product or00:36:33
or product safety00:36:35
we are talking about quality monitoring here00:36:38
product and process management00:36:41
who may not be responsible for00:36:43
building of variability during time00:36:45
production release or distribution00:36:47
influence practical attributes on00:36:50
quality technical attributes materials00:36:53
critical process process parameters and00:36:58
or control of political processes00:37:01
including those that may be related to00:37:02
registration dossier for medicines00:37:05
products if applicable and00:37:10
or product safety monitoring and00:37:13
control of processes that provide00:37:15
effective alert management00:37:18
various reviews, complaints or00:37:21
adverse events average00:37:23
criticality is00:37:26
whose data belongs to attributes00:37:28
quality attribute material00:37:31
process parameters00:37:33
key process parameters or00:37:36
means of managing processes that00:37:40
not one of the critical attributes on00:37:42
critical process parameters and00:37:44
may or may not be in00:37:46
registration for medicinal00:37:48
means multiple personality is when00:37:50
intended use00:37:53
before is to provide00:37:55
evidence of correspondence between Jane and00:37:57
associated with monitoring and control with them00:38:01
fall under the category of juice and medium00:38:05
to determine existing controls00:38:08
given levels of android data needed00:38:11
evaluate them controls00:38:14
high level data associated with00:38:16
proven automated00:38:18
processes and minimal real00:38:21
person throughout the positive00:38:23
Western then as control up00:38:25
low level are controls00:38:27
data that includes manual processes00:38:30
with a high degree of human intervention00:38:33
throughout the entire life cycle00:38:35
data high level is a high degree00:38:38
automation of its alloying processes00:38:41
electronic life cycle e.g. collection00:38:44
analysis of reporting to the minimum00:38:46
human intervention medium level00:38:49
hybrid manual processes00:38:51
semi-automatic life processes00:38:53
data cycle00:38:54
partial or lack of systemic00:38:57
interfaces low level is vital00:39:00
data loop00:39:02
maintained manually data manually e.g.00:39:05
there's capture and00:39:09
or data confirmation00:39:12
including00:39:14
2nd person who confirms the deposit00:39:18
data manual technological measurements and00:39:21
testing manual processes with high00:39:24
degree of human intervention00:39:27
data vulnerability as we already said00:39:29
this is an indicator of the degree of exposure to00:39:33
data integrity problems00:39:34
internal shortcomings 3 key00:39:36
elements of this control technology00:39:37
human factors data and00:39:40
Jim's production processes and or00:39:43
combinations to determine vulnerability00:39:45
collected data user first00:39:47
must assess the level of criticality00:39:49
data and exist at the level of control00:39:52
so everyone will be rated as high00:39:56
average or no stool according to00:39:58
definitions00:40:00
given on the previous flight after00:40:03
you can create a wall of nine children and00:40:06
comparing the level of accuracy to levels00:40:08
data management network of 9 people00:40:11
helps to visualize how critical00:40:14
data and data controls00:40:17
interact to rank the level00:40:20
risk00:40:21
the finiteness of the data will determine00:40:23
string of walls and vulnerability while00:40:27
level of control related to data00:40:30
will determine the corresponding column00:40:32
this grid is based on levels00:40:35
ranking high medium and low00:40:36
risks, businesses can adapt it00:40:39
to reflect your needs and00:40:42
use different criteria can00:40:44
risk reduction for criticality data and00:40:47
data control level00:40:50
will receive a premium vulnerability dunk the same00:40:52
will be necessary00:40:54
adapt if production00:40:55
they use their hike as a platform00:40:59
grid includes 9 unique combinations00:41:03
pairs of data criticality and control levels00:41:06
data that can be grouped00:41:08
four different categories of season 1 are00:41:12
significant vulnerability yes to the level00:41:14
data troll drives for data only00:41:16
criticality orange zvana it will moderate00:41:19
vulnerability and where is the level of control00:41:22
incommensurate with data criticality green00:41:25
zone is an acceptable data vulnerability00:41:27
troll level of measurable transience00:41:29
data and the blue zone is insignificant00:41:32
data vulnerability can be identified00:41:35
more controls she demands it00:41:39
applicable only don't have data00:41:41
high criticality00:41:44
the goal of this approach is to00:41:46
name is the correct level of control in00:41:50
depending on the importance of the data avoid00:41:52
hits red or orange fields00:41:54
thus the goal of the mitigation strategy is00:41:57
move from right to left by00:41:59
increasing the level of control is given in this00:42:02
evaluation all data from real jim00:42:04
are decisive even if they00:42:06
relate to Putin's operations grid00:42:09
make cells does not give any00:42:10
opportunities or cover for00:42:12
data falsifications are shown on the slide00:42:16
children only data controls00:42:19
related workshop control technology00:42:21
data for a complete vulnerability assessment00:42:24
necessary in the same way with her00:42:26
controls00:42:27
data related to human00:42:30
factor and the process is not immediately00:42:33
let's talk briefly about how again00:42:36
data analysis is carried out00:42:38
the first stage products are selected product00:42:42
and define data that can00:42:44
affect compliance with specification00:42:46
or intended use00:42:48
the second stage sets priorities for00:42:51
internal assessments determine factors00:42:54
risk and classifies data vulnerability00:42:56
for critical processes third stage00:42:58
three categories need to be considered00:43:01
do you influence the vulnerability of data?00:43:04
data management technologies00:43:05
human factor and the extraction process and00:43:09
at the fourth stage these00:43:13
three categories when assessing a specific00:43:15
data management process for00:43:17
evaluate operations after completion00:43:20
this analysis for a specific process00:43:22
or single operations00:43:25
received completed information can00:43:27
be used for the same process00:43:30
or lower operations00:43:32
used for other products must00:43:36
to be alone potentially00:43:38
various00:43:39
what is important is that for management00:43:41
data must take into account the full00:43:45
data life cycle to determine00:43:47
area of your vitriol00:43:49
This slide provides examples00:43:52
potential data reciprocity probe00:43:54
associated with each of these three categories00:43:57
disks as for the quality factor then00:44:00
to identify data vulnerabilities00:44:02
must take into account the point of human00:44:04
data lifecycle interventions00:44:06
because people tend to make mistakes00:44:09
processes that are largely00:44:11
depends on manual collection and analysis00:44:13
data are considered inherently more00:44:15
vulnerable topics automated process00:44:18
for the Jay Pei process necessary00:44:21
your complexity and reliability of the person being assessed00:44:23
production process to00:44:24
determine the area of data vulnerability00:44:27
more complex processes can produce00:44:29
a larger volume is given that can00:44:33
increase00:44:34
number of factors influencing00:44:35
vulnerability of data when assessing is necessary00:44:38
consider those aspects00:44:39
production process and evaluate00:44:42
each process in each specific00:44:44
case00:44:47
adjustable electronic recording00:44:49
controlled using simple autonomous and00:44:53
large integrated complex systems00:44:56
fantastic companies carry00:44:58
responsibility for complete control of all00:45:02
windows of server systems and controls00:45:05
has on the left no jimpet at the enterprise00:45:08
assessments of the used00:45:11
computerized systems including00:45:12
their intended use and00:45:15
operation as well as any risks or00:45:17
data integrity vulnerabilities00:45:19
which can be00:45:21
exposed to00:45:23
special attention to lose definition00:45:27
criticality towards green systems and any00:45:29
related data relationships00:45:32
product quality when determining00:45:34
vulnerabilities and risks to data are important00:45:37
to end the backup system00:45:38
contextualize the use00:45:40
within the business process requirements for whether00:45:43
Danish operating grain map system00:45:45
reflected in Appendix No. 11 to00:45:47
good manufacturing practices00:45:49
practices approved by order of the Ministry of Natural Resources00:45:51
bargaining grow number 916 not seventy00:45:54
the seventh decisions in these documents00:45:56
are determined00:45:58
regulatory requirements critical00:46:01
records in the field of jumpy managed with00:46:04
through politicized systems that00:46:06
oriented data integrity cookies00:46:10
feed the eroded system must00:46:12
comply with regulatory requirements00:46:13
and applicable guidelines which include00:46:16
System validation requirements must be00:46:19
in the lead for use by00:46:20
purpose which requires an understanding of the function00:46:22
capture jealousy from the theme within00:46:24
specific business process validation00:46:26
the system is politicized00:46:28
documented process of achievement and00:46:30
maintaining compliance with applicable00:46:32
rules of jumpy and suitability for00:46:34
intended use through implementation00:46:35
principles of approaches and00:46:38
life cycle event within00:46:41
editorial plans and reports as well as00:46:43
by applying appropriate00:46:44
operational with android throughout00:46:46
the entire service life of the system00:46:48
validation should include00:46:50
necessary control measures for00:46:52
ensuring data integrity including00:46:54
original electronic data or00:46:56
print or chicks in electronic00:46:58
formats received from the system therefore00:47:00
when validating collective systems and when00:47:03
subsequent control of changes is required00:47:05
implementation of confirmation that everything00:47:07
necessary controls for00:47:09
data integrity is available in00:47:11
presence that errors occur in00:47:14
Data is lonely Minin00:47:15
computer systems validation process00:47:18
this is a key step to ensure00:47:19
electronic data integrity process00:47:22
validation is provided by documented00:47:24
evidence allows with high00:47:26
degree of confidence in concluding that00:47:28
conquer grain system is functioning00:47:30
in accordance with its specifications and00:47:32
quality requirements and regulatory00:47:35
requirements for permanent00:47:36
on a reproducible basis in addition00:47:39
the validation process must ensure00:47:41
documentary evidence that00:47:43
the system includes automated00:47:45
points are focused on ensuring00:47:47
compliance requirements jane and and00:47:48
principles and managed and plus in relation to00:47:51
political electronic records00:47:54
if you came across see and00:47:56
mothballing systems means faster00:47:58
most of you know spears left00:47:59
Gump 5 recommendations which00:48:02
describes a flexible approach based on00:48:05
risk assessment for green00:48:07
systems that meet jig requirements00:48:10
spin00:48:11
when developing specifications00:48:13
design and testing00:48:15
computerized systems are necessary00:48:16
use rice clinker approach00:48:18
if we talk about the stages at which it can00:48:21
be a Jew with no quality systems00:48:23
products then this arrow stage is about00:48:27
determining the planning requirements00:48:29
stage oriented staging necessary00:48:31
set the distribution of responsibilities for00:48:34
definition of timing procedure and table00:48:36
system-related implementation project00:48:39
based00:48:40
documented specification00:48:42
user requirements on alloyed00:48:45
to detail the business need and00:48:47
users from the point of view00:48:49
business processes for compliance00:48:51
requirements and technical lines00:48:53
functional standards that will00:48:56
the initial stages of the project have been determined00:48:58
implementation00:48:59
specifications and creations based on00:49:03
Everest supplier performer creates00:49:06
set of documented specifications for00:49:09
configuration design definitions00:49:10
system quantity and level of detail00:49:13
Specifications may vary00:49:15
depending on the type of system and00:49:17
intended use it is00:49:19
qualifications the project is created by the mother for00:49:22
traceability and demonstrates00:49:24
relationship between specifications00:49:26
relevant requirements and00:49:28
performing source code verification in00:49:31
in case the systems are custom-designed00:49:33
acceptance testing stage verification00:49:37
directional confirmation system00:49:39
that the specifications have been met00:49:42
may include several stages of verification00:49:43
and not testing depending on type00:49:45
systems00:49:46
the method used to develop it00:49:49
usage testing should00:49:51
be based on assessment results00:49:53
functional claims and so release it00:49:58
the system is officially accepted00:50:01
use the release and you procyon and00:50:03
production environment in accordance with00:50:06
controlled and documented00:50:09
documented processes include00:50:12
birth from owners business process00:50:14
technical owner and00:50:15
the representative office would like quality work00:50:18
through a helper process00:50:20
This00:50:22
post-release phase after system release00:50:26
And00:50:28
after release the system will manage00:50:31
via auxiliary processes00:50:32
focused on maintaining MBA00:50:33
doped status00:50:35
end of use is the stage when00:50:38
the system is put out of service00:50:40
These supported systems must00:50:43
be available after their expiration date00:50:44
storage00:50:45
it is usually expected that there will be manifested00:50:47
prospective validation licensed00:50:49
system however for already installed00:50:52
systems can be pleasant acceptable00:50:54
conducting retrospective validation on00:50:56
based on the assessment of all historical data00:50:58
systems that have already been produced00:51:03
to mother greenness theme does not include00:51:06
software only00:51:07
application00:51:09
directly to the software00:51:11
provision for everything friend and subject00:51:13
connected tools and infrastructure00:51:16
personnel who can affect the jeep00:51:18
and atrophic process00:51:20
executed by the system each element00:51:23
systems must be documented and00:51:26
be monitored for shutdown00:51:27
bring down this status risks fights or00:51:31
defects usually increase with00:51:32
increase00:51:33
share of user software and00:51:36
hardware vs.00:51:38
share of standard software and00:51:39
hardware00:51:40
increased risk in agreed read00:51:43
more complexity and experience00:51:46
user categorization combined with00:51:48
risk assessment and supplier assessment00:51:51
may be part of an effective approach to00:51:53
quality risk management in00:51:55
Most systems have components00:51:56
some various difficulties00:51:58
operating systems are not00:52:00
configured components and00:52:02
customized or custom components00:52:04
to make it easier to define00:52:06
appropriate to the verification strategy and00:52:08
depths were defined into four categories00:52:13
on this slide00:52:17
presented category number 1 category00:52:21
my number one is infrastructure00:52:23
software on00:52:25
infrastructure elements are connected together00:52:27
creating an integrated environment for00:52:29
launching and supporting services application00:52:32
examples can be established00:52:34
webcams available multi-level00:52:36
software for example00:52:38
operating systems database manager00:52:41
programming languages00:52:42
middleware00:52:45
role interpreters taxes tool00:52:48
mental programming and package00:52:50
spreadsheet but not app00:52:52
developed using very packages and00:52:54
an example would be a tool00:52:57
software structure00:52:58
for example software for00:53:00
monitoring00:53:01
network packet planning tools00:53:05
tasks software for providing00:53:07
security antivirus programs and00:53:10
configuration management tools00:53:15
offering of the first category that is00:53:19
the expectation is that the documentation should00:53:21
correspond00:53:23
complexity and criticality of the system00:53:25
documentation for any system should00:53:27
contain all the necessary elements to00:53:29
demonstrate what she can do00:53:32
has been validated and is in a state00:53:34
control and how many documents are not important00:53:37
if all necessary elements are available00:53:41
the third category is not configuration00:53:44
components runtime parameters00:53:47
can be entered and saved on00:53:49
the software cannot be00:53:50
configured according to00:53:52
business process examples of such systems00:53:55
there may be application firmware on00:53:57
ready-to-use software00:53:58
use or tools loosening00:54:01
see with whom v-shaped validation scheme00:54:05
this type on such systems00:54:08
4 categories 4 categories configuration00:54:12
components for software00:54:15
often very difficult when it can be00:54:17
users are configured for00:54:20
meet specific needs00:54:21
user business process software00:54:24
the code where changes with examples of such00:54:25
systems and electronic document systems00:54:28
turnover resource planning system00:54:30
enterprises00:54:31
or scada system00:54:34
building management systems and so on00:54:38
us they also presented a diagram of gan00:54:42
5 for validation into imagery, can I?00:54:45
will give this type of system00:54:47
fifth category is custom00:54:50
self-developed application00:54:52
amazing and coded00:54:54
user what business processes are there00:54:56
software are examples of such00:54:59
systems and be a computer application00:55:02
custom electronic circuits00:55:05
macros in the table and on the slide as well00:55:07
a v-shaped diagram is presented and00:55:09
validation of this type of systems00:55:14
usually the level of detail and00:55:17
depth00:55:21
confirm documentation must00:55:24
increase with increasing category00:55:26
systems complex combined systems00:55:29
may consist of several components00:55:32
which may relate to different00:55:34
categories in this case the system should00:55:36
be classified look with00:55:38
highest category in related00:55:40
components if one or00:55:42
limited number of components00:55:43
custom designed system everything is possible00:55:46
still classified as category 4 on the list00:55:48
custom developed components00:55:50
classified into category 500:55:53
the validation life cycle is complex and00:55:55
backup systems shown in this00:55:57
slide of this figurative model in short00:56:00
describe something during validation to material00:56:02
systems can be highlighted as follows00:56:03
stage planning and evaluation stage00:56:06
supplier00:56:08
stage requirements and specifications detailed00:56:13
a risk assessment is required for this00:56:14
system creation specifications00:56:16
through the execution of process and00:56:19
or functional risk analysis with00:56:22
for the purpose of identifying those who00:56:24
may affect the correct or00:56:26
reliable operation of the system00:56:28
process level and items respectively00:56:31
functional risk assessment determines00:56:34
regulatory compliance and00:56:36
comparison risk severity00:56:38
existing functional00:56:39
system capabilities and supported00:56:42
processes00:56:43
the next step is00:56:45
test reception to mother systems and00:56:49
the last stage is commissioning00:56:53
inspection process00:56:54
production sites is carried out00:56:56
documentation check connectivity00:56:57
validation of collective systems for00:57:00
subsequent slides00:57:02
These types of plan documents are considered00:57:05
were will give it00:57:07
the strategic document confirms that00:57:09
all electronic events are held00:57:11
must in a manner using risk00:57:13
nuclear approach document should00:57:16
determine life how much validation and00:57:18
volume indulged in by determining00:57:20
system boundaries is also the result of an assessment00:57:24
supplier must be considered together00:57:26
with terms of use of documentation00:57:28
provided by the supplier00:57:30
in terms of isolation there should be00:57:32
the list of created00:57:35
documentation00:57:36
distribution of responsibilities and00:57:38
general eligibility criteria00:57:40
revolutionary process00:57:41
evolutionary plans must be00:57:43
applications00:57:45
the purpose of documents and rice is00:57:48
determination of the purpose and functions of the system00:57:51
including all basic requirements00:57:53
functional specifications should00:57:55
contain accurate and detailed descriptions00:57:57
how the system satisfies00:57:59
requirements for computer00:58:02
system and external interface00:58:04
this includes a description of the function00:58:06
representation of wind restrictions00:58:09
the document defines what should be done00:58:12
what functions of the tools are allowed by the system?00:58:15
the system itself, including a list of design00:58:17
system goals00:58:21
configuration specifications are created00:58:23
to describe the list of components00:58:25
hardware and software00:58:28
scientists motivation topic00:58:30
system parameters for example password length00:58:33
which may affect one or00:58:35
several gimpet functions00:58:37
configuration specification defines00:58:39
system configuration baseline00:58:41
addressed by the component interface00:58:43
software and00:58:45
system parameters mainly00:58:47
focusing on configuration items00:58:49
which may affect the jeep00:58:52
functionality00:58:54
the project does not have the specifications required for00:58:57
benefits of the skit components in order to00:59:00
provide detailed technical00:59:02
description of certification functionality00:59:04
to explain how the system does something00:59:06
what is defined by the highest specification00:59:09
level00:59:10
installation qualifications this also00:59:13
called configuration there is this00:59:15
activities regarding installation verification and00:59:20
device program configuration00:59:21
system components and related00:59:24
documentation for installation qualification00:59:26
it is necessary to take into account the conditions in which there will be00:59:28
tests are carried out as a rule00:59:30
special is highly recommended00:59:32
testing during you should be00:59:34
completed checks required00:59:36
activities to give00:59:38
documentary evidence that00:59:40
testing and production always00:59:41
And00:59:42
qualifications of all connected00:59:44
tools and equipment and00:59:46
relevant infrastructure00:59:47
are considered as00:59:49
preconditions for this00:59:50
installation qualifications00:59:52
purpose of qualification of operation purpose00:59:56
is to demonstrate00:59:58
then the system and each of its functions01:00:02
processes01:00:03
identified as operating critically01:00:05
according to specification a01:00:07
testing should be based on01:00:09
anticipation of fictions is functional01:00:11
requirements specifications01:00:13
users and so on and also01:00:15
results of a detailed risk assessment for01:00:17
type definitions in tests if the system01:00:20
controls adjustable electronic01:00:23
records and signatures protocol01:00:25
operation qualifications must01:00:26
contain such tests and01:00:30
these tests should be aimed at01:00:32
providing controls to ensure01:00:34
coaxiality given01:00:36
in addition, if testing a garden with a common01:00:39
Regulatory requires features enabled01:00:41
documented control implemented01:00:43
supplier then at the qualification stage01:00:46
functioning prognostic01:00:48
the company must verify01:00:50
these points are responsible for compliance01:00:52
regulatory requirements for example01:00:54
control environment protection and01:00:58
this must be done in relation to01:01:00
specific environment and intended01:01:03
use every test01:01:05
carried out using in advance01:01:06
certain data and scenarios01:01:08
the result obtained with deliver01:01:11
expected derived from functional01:01:13
specifications01:01:16
peak operation qualification stage01:01:19
or requirements verification oriented01:01:22
to demonstrate that the system01:01:23
works efficiently and reproducibly01:01:25
suitable for intended use01:01:28
and that both the system and the operating01:01:31
environment including users ready01:01:32
launch into production01:01:34
dive operating qualifications must01:01:37
be carried out primarily by those assigned01:01:38
user representatives should01:01:41
be focused on confirming that01:01:43
that these are completed and correspond01:01:46
a tet approved for any creation01:01:48
analyzed and closed that everything01:01:50
connected to the standard system01:01:52
operating procedures manual01:01:54
installation and administration and01:01:56
user manual approved01:01:58
are not available and that all users01:02:01
who can access the system01:02:02
trained that everyone has access01:02:05
user was created in accordance with01:02:07
his skills and responsibilities that01:02:10
checking supported processes01:02:11
system based on results01:02:13
detailed risk assessment and what has been completed01:02:16
backup and recovery01:02:18
data in the work environment in electronic01:02:21
report01:02:22
collected and description of actions and01:02:25
relevant documents for the purpose01:02:27
demonstration of correct and complete01:02:29
performing the validation process in01:02:30
according to the plan will give in01:02:32
aviation account provides analysis01:02:34
data collected during the validation process01:02:37
and document all the results01:02:39
evolutionary activity including any01:02:41
compliance and follow-up01:02:44
approval of the registry variation report01:02:47
for motivated systems there must be01:02:48
updated to reflect confirmed01:02:51
system status include link to you01:02:54
worthy report is compiled matrix01:02:56
traceability that verifies coverage01:02:59
and the relationship between specifications and risks01:03:02
related to the system and performed01:03:04
testing activities01:03:07
when operating canned systems01:03:10
must be carried out to help or and01:03:12
processes that support01:03:14
preserved systems01:03:15
doped state01:03:18
The first such process is01:03:20
security management is an event and01:03:23
such activities must be carried out01:03:26
throughout the entire life cycle01:03:27
there is an automated system01:03:30
physical security which01:03:32
included for all relevant measures01:03:33
precautions for01:03:35
access and environment control01:03:39
protection of computerized objects01:03:41
systems about the theft of various destructions01:03:43
uncontrolled change or01:03:45
violations are logical safety01:03:48
This01:03:49
that security that includes those01:03:52
precautions for protection01:03:54
programs and data from01:03:58
unauthorized access or01:03:59
misuse or01:04:01
data manipulation such as protection01:04:04
anti-virus protection against external threats01:04:08
user identification procedures01:04:11
audit trail for created changed01:04:13
or deleted data role01:04:16
security must be implemented for01:04:19
providing access to jumpy data only01:04:22
pre-authorized operator01:04:24
respectively corresponding roles in01:04:25
companies01:04:27
maintaining separation of duties01:04:29
security management procedures01:04:31
apply to all users01:04:32
including super administrator01:04:35
end user users01:04:37
support staff including01:04:39
employees already receive support from suppliers01:04:44
the second process is agent management01:04:47
this is the process this process is intended01:04:50
to create a high level structure01:04:54
support and detailed standard01:04:56
operational procedures that give01:04:58
recommendations for action scenarios01:05:00
escalations and assessments and related01:05:04
tools this process can01:05:06
supported by software01:05:09
change management is procedures01:05:12
control01:05:14
informing about changes in abilities01:05:16
affect configuration items and01:05:20
and lego doped status system01:05:23
change management includes01:05:24
change tracking01:05:26
from their appearance to their implementation01:05:29
backup is a process01:05:31
copying data record and software01:05:34
protection against loss01:05:35
integrity and accessibility of the original01:05:38
data recovery is the next step01:05:40
record recovery01:05:42
or software when01:05:44
these procedures are necessary01:05:46
necessary to ensure01:05:49
system data recovery case01:05:51
system failures and subsequent loss01:05:54
data reliability recovery process01:05:56
must be checked during validation01:06:00
service level agreement should01:06:03
be signed with the supplier and or01:06:06
integrator gin pastis for medium or01:06:08
high level attachment agreement01:06:10
must provide adequate and01:06:13
timely service in case of incident01:06:15
this is also for the purpose of proper01:06:17
secure storage of system documentation01:06:20
which was created during development01:06:22
and which is stored by the supplier01:06:25
some activities for each01:06:27
system support plan sits fishily01:06:30
contains01:06:31
the following information01:06:34
These are alternative procedures in case01:06:37
unforeseen circumstances01:06:39
use instead of process steps01:06:41
which includes access to diesel01:06:43
systems management plans and methods01:06:46
making decisions on which will01:06:49
use during an emergency failure01:06:51
computer identification systems are important01:06:53
in terms of continuity01:06:55
activities of documents that01:06:57
must be temporarily stored until01:06:58
restoration of combined01:07:00
systems and01:07:01
test procedure for boring01:07:04
contingency requirements01:07:06
to going concern Chinese01:07:09
strictly given only for those01:07:10
systems that01:07:12
support critical01:07:14
time process and that is, systems01:07:15
which executes processes that are not01:07:17
can be interrupted without potential01:07:20
impact on patient safety and01:07:22
product quality and integrity01:07:24
data need to have a plan01:07:26
ensuring business continuity01:07:27
is determined in Linz, he plans for us01:07:31
archiving is the process of archiving01:07:33
and data recovery it should be01:07:36
documented to undergo testing01:07:37
during the life cycle01:07:40
periodic review01:07:42
periodicity depth of periodic01:07:44
checks are determined based on analysis01:07:46
risks associated with the system for01:07:49
planning periodic inspections01:07:50
personally included directly01:07:53
electronic master plan periodically01:07:56
reviews are carried out in accordance with01:07:59
pre-established procedure01:08:02
and training and procedures for use01:08:05
systems01:08:07
What is important here is that such procedures should01:08:10
contain a section dedicated to special01:08:12
manner with a strong action appropriate01:08:13
each system such as01:08:16
adding a change and deleting an entry01:08:19
uploading or downloading data to workers01:08:21
stations or remote collection device01:08:23
system data check control01:08:26
trace01:08:27
curriculum and educational records must01:08:30
be supported in order to01:08:31
demonstrate to the inspector that01:08:33
system01:08:35
uses qualified and trained01:08:38
staff01:08:40
global systems validation process01:08:43
validation of such systems may include01:08:46
global validation package01:08:48
priority oriented01:08:49
ensuring functional reliability01:08:51
systems, each site can officially01:08:54
accept the result of global validation and01:08:57
create local specification01:09:00
testing documentation associated with01:09:02
functionality of the site01:09:04
there are those they have01:09:06
the validation process must include bio01:09:08
verification of processes performed01:09:11
through the system for each individual01:09:13
production site between01:09:15
the service provider company must be01:09:17
a technical agreement has been concluded or01:09:19
agreement which01:09:21
provides timely01:09:23
access to data including metadata and01:09:27
audit trails for data owners01:09:30
the company itself and national01:09:32
competent authority upon request01:09:34
contracts with suppliers01:09:36
determine responsibility for01:09:37
archiving and continuous readability01:09:40
data during the entire storage period01:09:42
companies01:09:44
up to the following types can be provided01:09:47
services on the slide are presented01:09:50
software as a service is01:09:52
when pharmaceutical companies don't01:09:54
manage and do not control the basic01:09:56
structure or even individual capabilities01:09:59
applications except for limited ones01:10:01
custom configuration options01:10:03
applications platform as a service is01:10:07
when pharmaceutical companies don't01:10:09
manages and does not control the basic01:10:11
cloud infrastructure including network01:10:13
operating servers for him or store but01:10:16
still controls deployed01:10:18
application and possible environment configurations01:10:21
placement of proposals01:10:23
infrastructure as a service is about it01:10:25
mystical companies they run01:10:27
basic cloud infrastructure but01:10:29
has control over01:10:31
operating systems01:10:33
were stored in detailed sentences and01:10:36
possibly limited control01:10:38
selected network components01:10:42
operation of the combined system01:10:45
are in the area of responsibility01:10:46
companies therefore life cycle and01:10:48
validation are linked the same way as before01:10:50
reflected on the slides earlier in the number01:10:53
other things must be checked and01:10:55
confirmed01:10:56
supplier assessment it should be01:10:59
done on the spot and kind and up to01:11:01
defining a validation strategy in terms of01:11:03
cavitation evaluation method of the supplier should01:11:06
be based on risk and related systems01:11:09
validation plan takes into account the results of the stage01:11:12
supplier assessments01:11:14
validation documentation may01:11:16
use specifications documentation01:11:19
according to installation qualifications and01:11:21
functioning fell which was01:11:23
provided by the supplier01:11:25
and if these documents are recognized on01:11:27
keep when evaluating the supplier01:11:29
sales performance agreement01:11:31
service level must be checked01:11:33
at the stage of testing but qualification01:11:36
Beijing operation or acceptance tests01:11:39
user are executed by the end01:11:42
pharmaceutical company user01:11:44
check that the system works according to01:11:47
assignment to the user himself based on01:11:49
rs requirements in all expected01:11:52
operating ranges01:11:54
there should be an audit of these security01:11:57
focused on at least the following01:12:00
aspects of how the supplier notifies01:12:02
regulated company about problems01:12:05
that affect data integrity01:12:07
security authorization requirements01:12:10
separation of duties process01:12:13
change management for improvement01:12:14
update fixes01:12:17
control storage requirements01:12:19
audit trails and event log01:12:21
access control mechanism mechanism01:12:24
identification and authentication01:12:26
encryption mechanism01:12:29
and fictions about structures even if01:12:30
infrastructure is managed by a third01:12:32
party and specification validation package01:12:35
testing protocol01:12:37
most often the group of auditors is included01:12:41
to an employee at a production site with01:12:42
relevant knowledge and01:12:44
competencies in these areas01:12:48
areas on and applications considered01:12:50
only as per the relevant categories01:12:53
four or five about classifications yes with01:12:57
pharmaceutical company point of view01:12:59
cloud application configuration should01:13:01
considered category 4 at the same time01:13:03
any custom development01:13:05
interfaces or data transfers are affected01:13:07
on Jim and associated with the cloud01:13:10
applications should be considered as01:13:11
corresponding to category 5 and should01:13:14
be tested accordingly01:13:18
spreadsheet validation each01:13:21
spreadsheet01:13:23
considered as singles01:13:25
canned systems and therefore01:13:27
critical spreadsheets are subject to01:13:30
inventory risk assessment and validation01:13:33
Accordingly, there are three categories01:13:36
tables purpose this category 301:13:40
not configuring this is electronic01:13:43
tables are simply used01:13:45
functions without configuration e.g. data01:13:48
conditional formatting validation01:13:51
category 4 configuration is01:13:55
spreadsheet performs calculations01:13:57
using customized formula formulas01:14:01
use basic zyxel for example01:14:03
addition subtraction division and category 501:14:06
this is custom this is electronic01:14:09
table use custom01:14:11
macros for complex or stacked01:14:14
logical similar functions01:14:17
Many laboratories use01:14:19
calculations customize spreadsheet01:14:22
to avoid possible data leaks01:14:24
must be checked to ensure that01:14:27
spreadsheet for him01:14:29
intended use01:14:31
this template will be on protect limited01:14:34
permissions to change the template and01:14:36
removal until usually01:14:38
validation customizing spreadsheets01:14:40
provides for checking the form which01:14:43
entered into a spreadsheet by01:14:45
fixes with accurate calculations01:14:47
testing boundaries and related01:14:49
functions01:14:51
minimal means of control that01:14:53
must be installed for custom01:14:56
spreadsheets and which should be01:14:58
standard operating procedures are prescribed01:14:59
procedures are01:15:02
encryption with password protection01:15:05
limit editing by click01:15:08
set to read-only so that01:15:10
this was stored in that blog01:15:12
saving spreadsheets to01:15:14
specified location on the server01:15:16
periodic password changes and revolution01:15:18
in accordance with standard specifications01:15:20
procedures01:15:22
what problems can there be with01:15:24
using spreadsheets01:15:25
for example a spreadsheet on it01:15:28
leading01:15:29
or pour accidental or intentional01:15:32
changes in forms01:15:35
entered by unsecured electronic01:15:37
tables01:15:38
here are other control results01:15:41
corresponding place not corresponding01:15:43
in a sophisticated spreadsheet01:15:46
lack of access controls01:15:49
spreadsheets where lack01:15:50
personnel training on use01:15:52
passwords01:15:54
the following slides will discuss01:15:57
Zarinsky's main requirement01:15:59
applications with themes 7 solutions01:16:02
systems must be designed for01:16:05
correct data collection obtained from01:16:08
using manual or automated01:16:11
manual entry facilities01:16:13
this should only be carried out01:16:17
authorized persons, the system must01:16:19
record progress and face data01:16:23
creating a record on and time to oblige01:16:26
has been done data must be entered01:16:29
on the provided format which01:16:31
controlled by software01:16:34
the validation event should01:16:35
confirm that they are valid and01:16:37
data formats they accept these walls01:16:40
All data entered manually must be01:16:42
verified either by a second operator or01:16:44
were green computer tools01:16:46
in that case and if01:16:49
they may affect product quality01:16:51
or patient safety01:16:54
changes in records including reasons for it01:16:58
register as a control01:17:00
trace and01:17:02
checked by the appropriate authorized01:17:04
and an independent person in accordance with01:17:07
risks to product quality and01:17:08
patient safety for01:17:09
automated data collection01:17:11
interface between source system01:17:14
data collection and recording systems01:17:16
you must be in the lead to ensure01:17:18
accuracy of data on data received01:17:21
systems must be stored in memory01:17:23
format that is not subject to01:17:25
manipulation and loss or change01:17:28
the system software must01:17:31
include in alloy checks for01:17:33
ensuring the completeness of the received data and01:17:35
also any methods related to data01:17:37
all necessary data changes must01:17:40
authorize and delete accordingly01:17:43
approved procedures, for example manual01:17:46
cropping and reprocessing01:17:48
laboratory test results01:17:49
must be carried out by an approved and01:17:52
in a controlled manner01:17:53
quality service company must01:17:56
take measures to ensure and introduce01:18:00
data changes only in case01:18:01
necessary and only designated01:18:03
persons01:18:04
This slide presents the requirements01:18:07
To01:18:10
here you are from the city01:18:12
this is considered strength control01:18:15
which says that for01:18:17
critical data, we enter it manually01:18:19
additional consideration should be given01:18:21
control of data entry accuracy01:18:24
control should be carried out on01:18:26
atr market or using its alloyed01:18:28
electronic means and paragraph 1001:18:31
configuration change management01:18:34
which states that any changes in01:18:36
nervous system including configuration01:18:38
systems should only be carried out01:18:40
in a controlled manner and in accordance01:18:43
with established procedure01:18:47
access to the system for controls01:18:51
user access both physically and01:18:53
so electronic they should be01:18:55
configured and used for01:18:59
crouched unauthorized access01:19:01
change not and delete data for everyone01:19:05
employees need access and01:19:07
use specific on electronic01:19:09
systems are established by Christ his01:19:11
individual logins and shared passwords01:19:14
Login credentials do not allow01:19:17
track the person who performed it01:19:18
actions for this reason general passwords01:19:20
should be completely banned01:19:23
beam and there is a system they turn on for01:19:26
access control functions using an example for01:19:28
it does not require a password or if it should01:19:31
use shared accounts01:19:34
or valences must be realized01:19:36
control measures which may include01:19:38
for example, we fill out a paper journal01:19:41
transparent ensures traceability01:19:43
access to the system or third party01:19:45
the software allows01:19:47
provide the system only01:19:49
pre-authorized by the emperor01:19:52
suitability of such alternative note01:19:56
must be justified and01:19:57
documented01:19:59
user authorization01:20:01
should be fully used01:20:04
access control mechanisms for01:20:06
ensuring that it is difficult to have01:20:08
access only to the relevant01:20:10
official role and so that action01:20:12
treated tankred01:20:14
the company must be able01:20:16
demonstrate access level01:20:18
provided to individual employees and01:20:20
ensured after all retrospective01:20:22
information about access levels01:20:23
users01:20:25
access control should be applied as01:20:28
when leaving the operating system even01:20:30
at the application level to the individual01:20:32
taste of the system at the operating level01:20:34
systems may not require driving01:20:37
appropriate controls for01:20:39
ensuring data integrity01:20:42
computer administrator access01:20:44
systems01:20:45
used to launch the application01:20:47
must be controlled by normal01:20:49
users should not have access via01:20:51
critical aspect of software01:20:53
software for example to system01:20:55
time for file deletion functions and so on01:20:57
Further01:20:58
system administrator right01:21:02
allowing actions such as deletion01:21:04
database change data or01:21:07
changes to the system configuration should not be01:21:09
be assigned to you directly01:21:11
interested in data, that is, those who01:21:13
creates this test she approves with whom01:21:17
Users must authorize01:21:18
ensure separation of duties01:21:22
backup backup process01:21:24
data backup and recovery01:21:27
must be documented using01:21:29
procedures are not determined exactly01:21:31
backup steps01:21:33
restoration that should01:21:34
be carried out if necessary01:21:36
backup process and01:21:38
recovery must be01:21:40
tested for01:21:42
provision01:21:44
full recovery possibilities01:21:46
data and metadata failure case by all01:21:49
a mechanism must be created01:21:52
backup for current01:21:54
upcoming corruption process01:21:56
backup and recovery file01:21:58
must be documented with us01:22:01
for example, using the procedure there should be01:22:03
should take the lead01:22:05
periodic checking is recommended01:22:07
so that a regular backup, for example01:22:10
media on which copies are stored01:22:12
data were born in a remote place01:22:15
physically separate in case of emergency01:22:19
situations01:22:22
data transfer check transfer then01:22:27
the data transfer itself is01:22:29
transfer process and method of income01:22:32
between media types or01:22:34
convert at the same time01:22:36
data transfer may be necessary01:22:38
change the data format to01:22:41
make them usable01:22:42
or visible to native Voltaire01:22:44
computer system transfer procedures01:22:46
data must contain appropriate01:22:49
rationale and you are carefully designed01:22:51
and tested to ensure integrity01:22:52
data over the course of life many cycles and01:22:56
on this slide01:22:58
you see01:23:00
data security requirements is a point01:23:03
5 data with the data storage in which01:23:09
point m2 which says happy01:23:12
perform regular backup01:23:13
copying all necessary data for01:23:17
maintaining the accuracy of backup copies01:23:20
also the possibility of data recovery01:23:21
must be checked during the process01:23:23
validation is periodically monitored01:23:25
And01:23:27
on this slide we see 12 I won't01:23:33
read the points here regret01:23:36
means of ensuring01:23:40
protection01:23:41
yes and01:23:44
on this slide you see01:23:48
Issue 15 of the series which says that01:23:51
from for registration procedure01:23:54
series release approval used01:23:56
the system is politicized it should01:23:58
provide access to release the series01:24:00
only to an authorized person and01:24:02
must clearly identify and01:24:03
register an employee who01:24:05
approved and exported the series for sale01:24:08
actions must be carried out with01:24:10
using01:24:11
electronic signature01:24:13
as I already said access control to01:24:17
electronic system is necessary for01:24:18
prevent potential problems01:24:20
related to data integrity for01:24:23
systems to protect to high criticality01:24:26
for each individual user01:24:27
means must be provided01:24:29
unique identification and01:24:31
authentication01:24:33
others should also be available01:24:35
functions such as mandatory shift01:24:36
password after a certain number01:24:39
days01:24:40
bloggers account after01:24:42
a certain number of unsuccessful01:24:44
repeated password attempts01:24:46
use of previously used01:24:48
password should only be allowed01:24:50
after a certain number of cycles01:24:53
annual account review01:24:55
users for systems that store data from an average01:24:58
degree of criticality01:24:59
measures can be of the same many types01:25:02
strict for low critical system01:25:04
access control can be much01:25:05
less strict for these types of systems01:25:08
a password or group password is acceptable01:25:12
cut however must be01:25:14
controls are provided to01:25:16
ensure separation of duties01:25:17
between user levels for example01:25:20
administrator engineer and operator password01:25:24
or group account should01:25:25
change after a certain period01:25:27
time and frequency with which should01:25:29
perform certain actions01:25:30
which01:25:32
I said01:25:34
must be determined based on01:25:36
risk assessments to ensure that01:25:38
frequency of action of mirri maz01:25:39
demonstrated risks, this assessment should01:25:41
take into account the overall system architecture01:25:44
interface between systems criticality01:25:47
access by unauthorized persons and the possibility01:25:49
network security violations01:25:52
regarding backup01:25:54
electronic data were identified two01:25:56
different scenarios which are acceptable01:25:59
distinguish between the control measures applied in01:26:02
depending on criticality first01:26:04
script for clean execution01:26:07
production backup01:26:08
data stored electronically01:26:10
companies should consider01:26:12
possibility of development01:26:14
principles-based strategies01:26:16
backup to01:26:18
differentiate periodicity01:26:19
backup this strategy01:26:22
must take into account the company's tolerance for01:26:25
risk including the mouth01:26:27
how can I recreate it in production?01:26:29
activities in case of system failure when01:26:32
backup failed01:26:34
data if single and foliage01:26:37
activities that affect01:26:38
the safety or quality of the product is01:26:42
lost data this company should01:26:44
be prepared to reject the series and may01:26:47
require more frequent backup01:26:49
copying from the other side from the main01:26:51
if you can create it with the help of others01:26:53
means, for example, a fingerprint is recorded in01:26:55
manual information it may be01:26:57
used to justify less than 501:27:00
electronic backup01:27:01
data if the equipment supports01:27:04
automatic backup01:27:05
It is recommended to make a backup01:27:08
with the same frequency as01:27:10
data is created01:27:13
if new data is created daily and01:27:15
require daily backups01:27:18
in addition, the volume should also be taken into account01:27:21
data generated within a given period01:27:24
time period and ability01:27:25
electronic systems they have a volume of data01:27:27
without overwriting existing data01:27:30
the second scenario is associated with cyclical01:27:33
memory upon reaching capacity limit01:27:35
new data automatically01:27:37
re-record old ones for example long time ago01:27:40
don't wait for him capable they are 10 packs01:27:42
data given for package 1101:27:45
automatically overwrite this01:27:46
package number one for storage systems01:27:49
especially important data backup01:27:51
must occur before the data01:27:53
will be overwritten01:27:55
a similar expectation should be in01:27:57
regarding the system storing data01:27:59
medium criticality system should01:28:02
provide automatic recording01:28:03
audit trail01:28:05
which is a form01:28:07
metadata01:28:08
containing information related to01:28:10
actions related to creatures01:28:12
changes and deletions settled01:28:15
electronic records01:28:16
control environment notes must have01:28:19
the form and content are clear and they don’t believe it yet01:28:21
the following information01:28:22
name of person external change to data on01:28:27
description of time change date01:28:30
changes reason for change in item01:28:34
audit trail must be maintained at all times01:28:36
enabled and access to it is blocked as01:28:39
and other functionality01:28:40
aimed at ensuring integrity01:28:42
data to control should01:28:44
verify during system validation01:28:46
the system should be based on01:28:48
properly controls01:28:50
synchronized time for01:28:52
registration of events in order to ensure01:28:54
reconstruction possibilities and01:28:56
traceability a bunch of information hourly01:28:59
the zone in which this data is used01:29:01
if there are several remote sites01:29:04
operator does not return to change01:29:06
time or panel train case01:29:10
lack of automatic01:29:11
snake trace01:29:14
Jim with critical data as01:29:16
example, temporary measures will be01:29:19
papers and notes were used but when01:29:22
as long as the system is functioning01:29:24
audit trail and will not become available01:29:26
according to where the audit trail01:29:29
related to regulates donut throne01:29:31
are subject to external audit01:29:33
authorized user for the purpose01:29:35
checking for correct execution01:29:37
operations and making any changes01:29:39
modifications deletion or when writing these01:29:43
changes in source information in01:29:46
electronic dreams in those changes should01:29:49
be duly authorized01:29:50
check are related to control data01:29:53
traces should be part of the routine01:29:55
data verification approval process01:29:58
frequency of functions and responsibilities for01:30:01
audit trail testing should01:30:03
be based on risk assessment01:30:06
compliance and data recorded01:30:08
the topic should be motivated01:30:10
a procedure has been developed that01:30:13
describes how to check01:30:15
control environment01:30:17
This slide presents the requirements01:30:20
traceability of relationship data01:30:22
audit trail that says that01:30:25
control from the environment should01:30:27
available to be able to01:30:29
transformations are clear to users01:30:31
forms and01:30:33
be checked regularly01:30:36
electronic audit trail for can01:30:38
include several01:30:40
sources01:30:42
related to equipment on01:30:45
production, that is, information can01:30:46
stored files are called antennas than01:30:50
audit trail for example log what01:30:52
you and the system alarm log01:30:54
log file is worth the trend and tet them01:30:58
understanding where it is recorded01:30:59
information in the system at the same level01:31:01
operating system is still at the level01:31:02
applications is important for data protection and01:31:05
understanding where to become in the system01:31:07
information when performing a check01:31:09
audit trail and the person performing01:31:12
audit trail must be checked01:31:14
be independent and technically capable01:31:16
understand01:31:17
the audit trail is not recorded by this person01:31:20
must take part in the creation or01:31:22
checking checking in dana01:31:24
audit trail review assessment is01:31:28
risk-based tool01:31:30
which can help determine which01:31:32
audit trail elements should be01:31:34
check how often01:31:35
the tool can be used for01:31:38
any system having electronic01:31:40
control log and this assessment01:31:42
focus on change detection01:31:44
given and criticality to the point of view01:31:48
patient safety or quality01:31:49
products as well as the likelihood or01:31:52
possibility of changing data for01:31:54
assessment, it is necessary to gather between01:31:56
functional group in the team should01:31:58
enter people who fully understand01:32:01
technical capabilities and system01:32:03
understand how it works from the point of view01:32:06
user management where they are stored01:32:09
data what type of data is part of01:32:12
audit trails command also01:32:15
should include users familiar with01:32:17
operation of the system is the first step in the process01:32:20
the score is the score of each of the three01:32:23
factors presented on the slide01:32:25
we discover the signs of seriousness and01:32:28
probabilities that may require01:32:30
checking based on system stuff01:32:32
controls for each element01:32:34
in the audit trail for each01:32:37
factor, a lower score means01:32:39
less risk, for example, assessments that01:32:42
can be used are shown on the slide01:32:45
although each company can change01:32:47
assessment based on your own01:32:48
analysis for indicators we find01:32:50
together based on probability01:32:52
change or deletion detection01:32:54
data has two possible values01:32:56
detected units or 0 if01:33:00
it is possible to detect any changes01:33:02
or deleting data to contain in01:33:04
audit trail and this data is what01:33:06
tested as part of existing01:33:08
checks according to requirements01:33:10
stops are the execution of additional01:33:12
audit trail checks for01:33:14
detection of potential integrity01:33:16
data01:33:18
not required, for example, if the report01:33:21
production series listed01:33:23
critical parameters are used in01:33:25
production time and any snakes shown01:33:27
entered into these parameters during01:33:29
series production01:33:31
audit trail review that is later01:33:34
no information needed01:33:36
suppose the report is created01:33:38
automatically on the equipment cannot01:33:39
be changed01:33:41
put at20 if you add days were01:33:44
have been verified or have only been verified01:33:46
some further may be required01:33:48
audit trail estimates then01:33:49
rating remains 1 severity rating01:33:52
based01:33:53
she always evaluates critically01:33:56
potential impact of a change or01:33:58
data deletion exists exists01:34:01
three possible values of the degree01:34:02
severity 10 4 or days place if01:34:06
data is considered very important or has01:34:08
direct impact on patient safety01:34:10
or product quality for example01:34:13
temperature change01:34:16
being outside the permissible limits01:34:18
range01:34:19
then the potential impact has01:34:21
high severity01:34:22
the action is rated if it’s been a while01:34:25
has an indirect impact on safety01:34:26
patients or product quality, that is01:34:29
changes to data that are only related01:34:31
with the risk of compliance with indirect01:34:34
influence only on the quality of the product or01:34:36
patient safety01:34:39
this is a special average potential01:34:42
severity level01:34:44
score 4 if the data is significant01:34:47
influence or and influence safety01:34:48
patient or product quality01:34:52
they have a low potential for seriousness01:34:55
then the score is 1 rating01:34:58
probability it is based on possibility01:35:01
changing or deleting data01:35:03
users and system operators01:35:05
there are three possible meanings01:35:07
probabilities01:35:09
10th or units if the data can be01:35:12
changed or deleted user01:35:14
user applies to anyone in the forest world01:35:18
fixed as independent01:35:20
registrar then estimate 10 months if data01:35:23
cannot be changed or deleted01:35:27
user may be changed or01:35:29
deleted by an independent administrator then01:35:31
there is a face they have direct interest01:35:33
yes then01:35:35
the assessment was given01:35:37
if the data cannot be changed or01:35:42
deleted by more than one user or01:35:44
the administrator considers this very01:35:45
low probability he is trying score 101:35:50
after that then threaten'd and01:35:52
discover the severity and likelihood01:35:54
multiply to get the final01:35:56
ratings, the lower the rating, the lower the risk in01:35:59
The table shows how to use01:36:00
final grade to reduce01:36:02
required frequency of inspection01:36:04
audit trails when used01:36:06
risk-based approach01:36:09
the frequency of inspections should be01:36:11
measurable with identified system risks01:36:13
and and apply if during01:36:15
periodic checks detect01:36:17
a number of friends disagree on the matter and01:36:20
controls or frequency01:36:23
checks should be re-evaluated to01:36:25
stop violating the future or quickly01:36:28
or detects a violation faster01:36:32
practical examples of shades01:36:35
maybe if we, for example, are with you01:36:38
consider01:36:40
we can consider three different types01:36:42
data01:36:44
electronic audit trail which01:36:48
which registers given01:36:51
during the production of the rs series he drug01:36:54
for example, the audit trail may be01:36:56
such data related to settings01:37:00
series such as the recipe used and01:37:04
set value or time01:37:06
planned for certain01:37:08
operations during batch production01:37:11
throne magazine may not include information about01:37:13
series that represent data01:37:15
production process for example01:37:16
temperature operation duration01:37:19
then the action was performed and the log be01:37:23
system configuration data included01:37:25
which are not data related01:37:28
to the series are data associated with01:37:31
system configurations such as information01:37:33
about the user account01:37:35
but provided by the user01:37:38
privileges where data is stored01:37:40
the audit log contains all this data and01:37:43
each of these parts which log01:37:45
has a number of elements that can be01:37:47
considered during inspection01:37:49
consistent assessment tool01:37:50
should be used for everyone01:37:52
separate element to define01:37:54
final assessment01:37:56
data verifiability requirements01:37:59
electronic copy the system should01:38:02
allow you to create accurate and complete01:38:04
copies of the recording as we read in the ice in01:38:07
electronic form suitable for verification01:38:09
for grades and first place sides01:38:13
inspectors01:38:14
data archiving should be done periodically01:38:16
archive in accordance with written01:38:19
backup archival procedures01:38:21
copies of data should be stored in different01:38:23
data must be accessible and01:38:26
readable and their stealth should01:38:28
be supported throughout01:38:31
period surgery should be01:38:33
recovery procedure provided01:38:34
archived data is better than necessary01:38:36
conducting an investigation01:38:38
recovery procedure for archived data01:38:40
should be checked regularly01:38:42
removal must be worked out01:38:44
procedures describing the removal process01:38:47
electronically stored data01:38:49
these procedures must contain01:38:51
guidelines for assessing data and their01:38:54
during the storage period and01:38:56
describes the order01:38:57
they are data that is no longer required01:38:59
This slide presents the requirements01:39:02
verifiability from requirements data01:39:04
printout for working with printouts and01:39:08
archiving01:39:11
to confirm suitability and control01:39:16
regarding signed entries should01:39:18
carry out proper validation is related to01:39:20
topic signature processes case preparation01:39:23
paper or pdf copies of the document with01:39:26
metadata is associated with an electronic signature01:39:29
with an electronic signature must be preserved01:39:30
per month of relevant documents01:39:32
electronic signature or systems01:39:35
electronic signature must01:39:36
provide for the manifestation that is01:39:38
display01:39:39
within the visible record of the one who01:39:41
signed the position to sign what01:39:44
where possible date and time if it is01:39:47
necessity means we and also01:39:50
value of signatures for example verified01:39:52
inserted image approved01:39:54
signatures or footnote indicating that01:39:57
the document was signed electronically01:39:59
form and if it was visible in a way01:40:01
excellent aque doped process01:40:03
electronic signatures are01:40:04
insufficient if the document is signed in01:40:08
electronic form01:40:09
who the metadata associated with the signature should01:40:11
be stored in01:40:12
This slide presents the requirements in01:40:16
respect01:40:18
whose electronic signature says01:40:21
that electronic signatures must01:40:24
within the enterprise has the same01:40:25
meaning as a handwritten signature be01:40:28
inextricably linked with the corresponding01:40:30
records include the time and date when they01:40:33
were delivered01:40:36
basic principles for ensuring01:40:39
alignment of these laboratories on how01:40:42
previously discussed data can and01:40:44
static01:40:45
that is, devices01:40:49
laboratories can take01:40:53
paper printout or static01:40:57
images during data collection in01:40:58
as the original recording and if we01:41:01
talking about dynamic data here01:41:03
the device on the printout cannot convey01:41:06
the nature of the data is only part01:41:07
original recording01:41:09
companies must justify their choice of entry01:41:11
paper electrons depending on01:41:13
static and dynamic data in01:41:15
in case of dynamic data is required01:41:17
enter the original electronic record01:41:20
records include original data with those01:41:22
this data must be recorded01:41:23
simultaneously with step a or event for01:41:25
xp regardless of whether01:41:27
process and data manual paper or01:41:30
automatic electrons at01:41:32
conducting microbiological tests01:41:35
visual graphic data after01:41:37
established incubation times01:41:39
must be observed01:41:42
extracted from materials such as01:41:45
petri dish contact plates and01:41:47
recorded either manually on paper01:41:50
document or into a digital system without01:41:52
Various changes or distortions01:41:54
psychological factors can cause01:41:57
or put pressure on a person in01:41:59
as a result of which a person may behave01:42:01
inappropriately or to allow01:42:03
careless mistakes01:42:05
every company should have01:42:07
related controls and01:42:09
system that will allow you to easily01:42:11
detect by seeing and pattern and which01:42:14
does not meet the expected norm and may01:42:17
affect the quality of the product01:42:18
products01:42:20
let's talk about data integrity in01:42:23
microbiological laboratory01:42:25
approaches used for investigation01:42:28
problems related to data integrity01:42:30
which originated from microbiological01:42:32
laboratories can be problematic in01:42:34
in some cases they can be very01:42:36
different from those used01:42:38
to assess similar incidents in01:42:40
chemistry laboratories many01:42:42
microbiological methods are performed01:42:44
manually and subsequently accurate results01:42:47
are common based on visual01:42:49
observations of an individual specialist01:42:51
perform a protest on the slide01:42:53
examples provided do not correspond01:42:56
related to data accuracy01:42:58
microbiological duck is a practice01:43:00
foreign regulatory authorities01:43:05
let's look at each example01:43:09
microbiological results01:43:11
monitoring the production side of the environment01:43:12
were unreliable here we are talking about01:43:15
that the results found01:43:17
microbiological monitoring during01:43:19
inspection01:43:21
that is, 1 to 3 on a petri dish after01:43:25
counting microorganisms and01:43:30
the results were inconsistent01:43:33
the results that were reflected in01:43:36
electronic monitoring report01:43:38
it would be a stretch to kill thrush organisms and01:43:40
Cairo was discovered but in the reports there were01:43:43
have you written down the value01:43:46
in this example at the production site01:43:50
the site was not provided01:43:51
carrying out01:43:53
investigations upon receipt01:43:54
unsatisfactory results with01:43:56
conducting testing of intermediate01:43:58
products according to the indicator moved the approach01:44:01
the enterprise provided for carrying out01:44:03
investigation of the case of receipt do not tell01:44:06
this result obtained repeatedly01:44:09
that is, on more than one loss01:44:11
intermediate products01:44:14
the following example company used01:44:17
used the services of 2 9 points gical01:44:19
laboratories and01:44:21
periodic checklist somewhere01:44:23
third party laboratory was filled01:44:25
employees of a third-party laboratory and not01:44:27
was born by company employees01:44:29
in the following example the entry was found01:44:32
all his personal unofficial note01:44:33
microbiology book entries01:44:36
testified to the discovery01:44:38
pathogenic microorganism in water for01:44:39
mental application she herself records01:44:42
this information was missing01:44:45
in the following example were found01:44:48
materials about erase what and what01:44:50
All that's left is just a nutrient medium01:44:52
used for01:44:54
conducting a media phil test01:44:57
there was information missing from the records01:44:59
that the growth properties of nutritional01:45:01
Wednesdays were confirmed01:45:03
This slide presents ongoing01:45:06
microbiological laboratory operation01:45:08
when carrying out these operations one way or another01:45:11
otherwise problems may arise with01:45:12
data plane for the most part01:45:15
which are related to the specifics of work on01:45:17
I wanted to go to the biological laboratory01:45:19
I would like to highlight here two groups related to01:45:22
equipment that is used for01:45:24
microbiological laboratory work and01:45:26
discuss various equipment and01:45:29
measuring01:45:30
used microbiological01:45:31
laboratories can become a source01:45:33
problems associated with accuracy01:45:35
for example, improper operation01:45:38
equipment or durable calibration01:45:40
may lead to unreliable01:45:42
results if handled incorrectly01:45:44
various equipment and tools01:45:47
use of microbiological01:45:48
laboratories, for example, water incubators01:45:51
bathhouse crying meter and devices for01:45:54
production environment monitoring01:45:56
temperature control systems microscopes01:45:58
may become a source of problems associated01:46:01
it was worth here what could be an example01:46:04
connect the appropriate ones01:46:06
equipment and01:46:07
potential receipt corresponds01:46:09
Always01:46:10
for example during01:46:13
inspections or audits including01:46:15
himself and inspections for example can be01:46:18
checked for electronic data that01:46:20
were determined by automated01:46:21
microorganism identification system01:46:24
regular files store information in01:46:26
all isolates that were Ravana spokes01:46:29
electronic data can be01:46:31
compared with the data that is attached01:46:33
to up to 7 on the drug stereo01:46:35
or contributed paths to the backup system01:46:39
backup system used in01:46:41
laboratories, discrepancies in data may01:46:43
cause non-conformity or01:46:45
for example, an operation log01:46:48
equipment include repair records01:46:50
calibration of equipment during alcohol01:46:53
data can be compared01:46:55
from such magazines with actual01:46:57
using01:46:58
equipment that can be traced01:47:01
test reports, but it might work out01:47:03
so it was exploited in fear01:47:05
uncalibrated equipment then this01:47:07
may cause a violation01:47:08
data integrity since the result01:47:10
tests may not be delivered01:47:14
the following example is related to01:47:19
clogging of samplers over time01:47:23
and the holes of the sampler which01:47:25
is used for01:47:26
aspiration sampling01:47:29
gets clogged, which significantly impedes01:47:32
filling the air volume01:47:34
so that this air gets to the surface01:47:37
then despite the fact that01:47:39
communication technical malfunction01:47:41
maintenance or operation01:47:43
equipment this directly affects01:47:44
for data integrity01:47:47
microbiological01:47:51
physical-chemical data integrity01:47:53
laboratories01:47:54
physico-chemical cureit is blocked01:47:57
hybrid system is technical01:48:00
equipment01:48:01
the use of which depends on the rewards01:48:04
electronic and paper hybrid01:48:07
systems can be simple and systems01:48:10
capable of storing system test data01:48:12
this is an analytical balance, our meter and01:48:15
systems are capable of storing data this01:48:17
titrators01:48:19
equipped for dissolving and so on01:48:21
and if the devices are connected to a computer and01:48:23
is there any software01:48:25
then this is already laboratory optimized01:48:28
system risks associated with thick data01:48:31
when working with hybrid systems can01:48:34
be such a lack of traceability01:48:38
for all received data absence01:48:40
no passwords, no audit trail01:48:43
or deactivating it vulnerability dates and01:48:46
time for manual change01:48:49
is not enough and recovery is backup01:48:51
copying or single failure for example01:48:53
with hard drive no funds01:48:56
control preservation of original electronic01:48:59
data and data that is complete01:49:00
and regarding meta-data that can01:49:03
be associated with access to the computer itself01:49:05
basket or file lack of verification01:49:08
the second person of what is printed01:49:10
the document is an exact copy01:49:12
original data or effective01:49:14
fruitless electronic data report01:49:16
including all metadata result01:49:20
canned systems are devices01:49:23
which are connected by a computer to collect01:49:25
analysis and data storage typical01:49:27
examples are equipment for01:49:29
your g01:49:33
systems include hardware and01:49:35
sleep platform software01:49:38
as well as management01:49:40
standard operating procedures and01:49:43
ordinary analysts are shown in the picture01:49:46
typical data flow when conducting01:49:48
chromatographic methods of analysis and01:49:52
data management are included for01:49:55
creating processing reporting01:49:57
archiving before01:49:59
creation up01:50:01
criteria or characteristics that01:50:04
define the file yes this is the name of the analyst01:50:08
name of the drug01:50:13
sample description date and time of printing01:50:18
method parameters flow wavelength01:50:20
directorate volume recording time01:50:22
chromatograms01:50:23
sequential information about01:50:25
controls recommended for01:50:28
logging events in a log somewhere01:50:30
this is the number name introduction01:50:32
analyst name01:50:35
medicinal product01:50:37
reasons for change01:50:38
descriptions of the lek there for testing are not a review01:50:42
or permission of 2 analysts before01:50:44
performing the following test behavior01:50:46
data processing and peak requirements01:50:49
the quality service must determine01:50:51
standard protocols for processing01:50:53
data depends on the device or application01:50:58
must be determined again01:51:00
peak processing application tool01:51:03
specific applications by integrating01:51:05
event algorithm01:51:06
full integration of peaks banning or01:51:10
requirements of any games for test lameness01:51:13
gram without scientific basis01:51:15
application of one and the same01:51:18
integration for everyone about a set of samples01:51:20
and for the sequence rim base01:51:21
any changes to the integration01:51:23
printed on the programs must be01:51:25
visibility scale is presented according to01:51:28
corresponding analysis there is the top and01:51:30
the base of the peak is clearly visible for analysis01:51:32
after integration the results can01:51:35
be saved electronically01:51:37
results printed or published are not01:51:41
option of putting data on paper in01:51:43
in this case this is when it works out01:51:45
the final result which is impossible01:51:46
change without prior approval01:51:49
in the right system where you can't01:51:52
be changed without re-analysis01:51:53
which will only give you cheese01:51:57
after the approval of the manager and so on01:51:59
the final result is checked01:52:01
manager in accordance with01:52:03
established procedure01:52:05
chromatograms can be printed on01:52:08
paper and they should also be available in01:52:10
system for viewing01:52:13
in this slide you see the type01:52:15
audit trails01:52:17
control somewhere which may include01:52:20
chromatographic system01:52:22
Means01:52:24
there is sometimes an audit log at the level01:52:27
systems01:52:28
this is the testing log any along the way01:52:32
inputs-outputs01:52:33
ID01:52:35
dates and times of login and logout attempts01:52:38
device used functions01:52:41
executed when logging into applications01:52:43
And01:52:44
Application level audit log is01:52:48
control over the years at the project level is01:52:50
monitoring is available for such open and01:52:53
closure of data and actions regarding01:52:55
data for example editing walls01:52:57
processing and deleting records and fields on01:53:00
published and journal reports somewhere01:53:03
techniques clarify registration actions01:53:06
in the process of carrying out the technique this story01:53:08
changes in methodology methodology for and no01:53:12
changes between sequence01:53:14
log results somewhere01:53:17
chromatogram or reports contain type01:53:19
integrating the date of collection and processing and01:53:23
who performed them01:53:24
changes in chromatograms after01:53:27
obtaining results01:53:29
vogue magazine to sequence01:53:32
registration change make process01:53:34
sequence or or changes01:53:36
titles for series about or lectures01:53:39
after centuries you01:53:41
series changes about01:53:44
changing the sample name on time01:53:47
execute sequences using01:53:50
method for all injection removal01:53:52
sequence audit log on01:53:55
project level this registration is01:53:57
performed in relation to the series about entrances01:54:00
results of calibration curves a and01:54:03
peaks and the injection log is a registration01:54:06
date and time information01:54:09
The room is unsuitable for those standards01:54:12
sample and either simply01:54:14
let's now look at the possible01:54:16
problems related to data integrity01:54:19
this is also a practice in production01:54:23
foreign regulators and01:54:27
let's consider01:54:29
like each group and possible examples01:54:33
problems that may be associated with01:54:35
full data01:54:37
bond falsification fabrication01:54:40
record for example visual data01:54:43
control record for cleaning validation01:54:46
series production record annual01:54:49
reviews product quality check01:54:52
integrity of gloves insulator01:54:54
false or misleading01:54:57
statements made to inspectors01:55:01
or delay of castes01:55:04
restrictions when checking failure01:55:07
provide access to recording objects on01:55:09
google document or responsible persons01:55:11
and what prevents the inspector from completing01:55:13
check01:55:14
computer access control01:55:18
unsecured spreadsheet and for01:55:20
performing calculations and statistical01:55:23
general production data evaluation01:55:25
credentials that did not allow01:55:27
infect a specific person01:55:29
using a common login and for binding01:55:32
certain actions and to a certain01:55:33
to the operator in the general password used01:55:36
several people to gain access01:55:39
for each individual unit01:55:40
equipment and access level are not01:55:43
insufficient control to ensure that01:55:46
change in main production01:55:48
during control notes or other01:55:50
entries are made only by authorized01:55:52
staff01:55:54
next group01:55:57
[music]01:55:58
the following example is the absence of records01:56:01
data made simultaneously with01:56:02
of the operation being performed is a preliminary01:56:05
behind as if described by the notes01:56:07
production in the recording series01:56:09
production series signed by persons01:56:10
who did not perform the action01:56:13
control not spreadsheets01:56:15
which are used to record data01:56:17
quality in the production process which01:56:20
then transcribe and retroactively01:56:21
is recorded in the production record and01:56:23
in the recording both vices do not match01:56:26
video recordings serial data01:56:29
production in the 1st on breadboards01:56:32
for the next one for the next one01:56:34
transfer to official record01:56:36
dated words01:56:38
unexplained discrepancies in data01:56:42
production equipment marked01:56:43
as clean but found dirty in records01:56:46
production series missing important01:56:49
signature information01:56:51
erroneous grows and and use and01:56:53
correct amount of starting material01:56:55
during production on not accurate01:56:57
quantity for quality defects01:57:00
or recording optical filters01:57:04
production record tracking01:57:06
series01:57:07
well here01:57:10
programmable logic controller and01:57:14
production equipment01:57:16
and with general credentials that are not01:57:18
allowed01:57:19
stains or who uses that common label01:57:25
dante deleted destroyed or missing01:57:28
For example, records for01:57:30
series production, subscriptions,01:57:33
sanitization annual reviews01:57:35
product quality change control01:57:39
filtration checking filter integrity01:57:41
this media fil test this01:57:43
sterilizers checking weight in progress01:57:46
production output calculations01:57:49
undocumented deviations01:57:52
broken audit trail01:57:55
lack of audit trail for01:57:57
documented who had access01:57:59
to each of01:58:03
controllers and equipment shortage01:58:07
cars01:58:08
operating equipment parameters or01:58:10
electronic taste disabled01:58:11
audit trails for the system01:58:13
aerosol particle monitoring01:58:17
inaccurate incomplete data or records01:58:19
inaccurate entries in records01:58:22
production series is incorrect01:58:24
amount of active ingredients or01:58:25
raw precision, media stupidity inaccurate01:58:29
notes about spotter you win01:58:32
events or inaccurate clearance recording01:58:35
product quality01:58:37
series production records01:58:40
given in pencil and01:58:42
no one will wash down this use01:58:45
social01:58:46
recording which draft notes01:58:50
This slide shows the conclusions01:58:55
means when building a control system01:58:59
data you need to know the requirements and01:59:01
recommendations which you which01:59:03
defined in regulatory standards01:59:05
documents about mystical companies01:59:08
bear full responsibility for01:59:09
computerized ones they use01:59:11
electronic systems and generation01:59:14
data fulfillment of expectations I managed and01:59:16
plus this is a guarantee of product quality and01:59:19
patient safety quality culture01:59:22
must be transparent open01:59:24
improved the prognostic system01:59:26
quality is the use of modern01:59:29
principles of risk management and01:59:30
application of good practices01:59:32
data management01:59:34
computerized system must be01:59:36
he was led by demands01:59:38
regulatory requirements regarding01:59:39
operation of compensated systems01:59:41
must be respected colleagues thank you for01:59:44
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