Every good documentation practice observation is an data integrity issue

every GDP observation is Data Integrity Issue

  • Every GDP is DI Issue

    Votes: 0 0.0%
  • Every GDP Investigation need to defend why it is not DI Issue

    Votes: 1 100.0%
  • Every GDP evaluation for 'Impact' will lead to DI scope of action.

    Votes: 0 0.0%
  • Others!

    Votes: 0 0.0%

  • Total voters
    1

v9991

Trusted Information Resource
#1
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v9991

Trusted Information Resource
#2
ok, let me try to rephrase the question...
* How do you differentiate data integrity aspects vs documentation practices in your incident sop
* is there a checklist u follow to evaluate the incident wrt data integrity!
 

John Broomfield

Staff member
Super Moderator
#3
v9991,

Information is meaningful data.

Naturally, we try to avoid collecting invalid data from our measurements and observations for which you’d have to study the applicable testing, inspecting and auditing processes.

And data analysis is meant to exclude invalid data.

But valid data does not become documented information until the data are analyzed.

So, in PACA (prevention comes first!) if we suspect the integrity (completeness, accuracy) of the data we may design and conduct a study to determine or verify the facts.

Rarely, in my experience, does a data integrity problem become a documented information control problem.

Why are you jumbling data integrity with the control of documented information?

John
 

v9991

Trusted Information Resource
#4
v9991,

Why are you jumbling data integrity with the control of documented information?

John
Thank you helping me understand and ask the question correctly,.
the question is at system and process level of implementation of incident management procedure.

consider following scenario,
a. observation on 'online documentation of a log book or ongoing process" ' is reported or it is noted during the self-audit.​
a.1couple of other observations are also noted in the past.​
a.2 for scenario of 'reported incident', there could be unnoticed instances of online documentation​
a.3 for self audit observation, that certainly does not cover all.​

'online documentation' falls under "contemporaneous documentation". hence 'data integrity';
and hence the question on differentiating the DI vs Documentation practices.

b. similarly observation on " documentation on informal sheets or personal notebooks" reported or it is noted during self-audit.
and here the it is not 'traceability' and 'attributable' and 'accurate' and have data integrity.
hence the question where and how do your differentiate the DI vs Documentation practices
 

John Broomfield

Staff member
Super Moderator
#6
As in “I made the record at the end of the shift”?

Or

“I created the record just before I checked my own work”?

Yes, both of these tardy activities could result in inaccurate, false or fraudulent records.

By the way, “self audit” is a contradiction. You can check you own work but not audit it.
 

v9991

Trusted Information Resource
#7
As in “I made the record at the end of the shift”?
Or
“I created the record just before I checked my own work”?

Yes, both of these tardy activities could result in inaccurate, false or fraudulent records.
(y)AGREE.
and my question is how/what are the Data integrity points integrated with respective observation / incident .
are there any standard references / processes defined.
is there any standard practices

By the way, “self audit” is a contradiction. You can check you own work but not audit it.
(y) i meant to indicate internal-audit.
 

John Broomfield

Staff member
Super Moderator
#8
v9991,

Thanks.

Contemporaneous records are widely accepted as good practice in many industries, including pharma.

At first glance ISO 9001 is silent on this until you think about this requirement specified for record keeping:

“Documented information needed to be retained by the organization for the purpose of providing evidence of result achieved (records). These include:

Documented information to the extent necessary to have confidence that the processes are being carried out as planned

From: ISO/TC 176/SC2/N1286 Guidance on the requirements for Documented Information of ISO 9001:2015

Clearly, if the records are not kept at the time then we lose confidence in them. And confidence may diminish further as time passes.

Your organization may need to specify a requirement for timely record keeping.

Meanwhile here is a presentation on the subject:

http://asq.org/audit/2017/10/auditi...-not-just-for-the-pharmaceutical-industry.pdf

By the way, if you come across tardy record keeping, ask the supervisor or the users of the records how they feel about it. You may find that they would have little or no confidence in a tardy record. You then have your evidence of a nonconformity. You may write the nonconformity a little differently if you had evidence that the supervisor had failed to require contemporaneous record keeping or had not been monitoring and correcting record keeping.

Best wishes,

John
 
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