Question 11:
Many of our production processes are documented by means of a
batch record on paper. What should we do as concerns the review of the audit
trail? Should we review the good documentation practice in the batch record by
means of an audit trail review?
Best Answer: As long as you only document on paper the audit trail review is
not relevant for you, but the 4-eyes-principle for all critical steps.
The following is stated in the FDA Guidelines: "Critical
process steps have to be verified by a second individual".
Question 12:
Is it necessary to perform an audit trail review (ATR) after
each measurement/analysis carried out at the equipment in the laboratory? Who
carries out the ATR - laboratory personnel (operator) or the Head of the
Laboratory?
Best Answer: A SOP is required for the ATR for each system that describes the details. The
review after completion of the analysis is important.
Question 13:
How do you justify the reintegration of chromatograms versus
the method specification in the audit trail?
Best Answer: A reintegration should only be necessary if the analysis wasn't carried out for
one reason or another.
The
reason has to be specified and must be signed by the management. The laboratory
employee is not allowed to take the decision himself.
Question 14:
Can the review of a printout of the drying temperature profile
be considered to be part of the audit trail review of the batch?
Best Answer: In my opinion this is a good example for static data for which no audit trail
review has to be carried out. The reason is that the user cannot change or
access this data.
Question 15:
Is it acceptable that a user has the entitlement for
reintegration at a GC system or should the laboratory manager be the only
person authorised to do this? Are there any relevant requirements or
recommendations?
Best Answer: This should be regulated internally in an SOP. Preference should be given to
the laboratory manager since he has a control function. I know nothing about
any requirements concerning this.
Question 16:
16 Which measures may be taken if the audit trail (as well as the actual
data) can be deleted or changed at the level of Windows?
Best Answer: In the case of systems that can store locally on the HD of the user it is
possible to set up two local user profiles. Then, for instance, the system
stores data only on the profile the user cannot access.
Question 17:
What are the
essential parts of an audit trail?
Best Answer: An
audit trail has to at least record the critical variables/values, indicate the
initial value and the changed
one, indicate who has changed what and when.
This
includes a unique identification of the user, a date and time stamp as well as
possibly a
comment.
What’s new pursuant to Annex 11 is the comment on the reason for change. Here
it would be
possible to restrict the number of parameters to be commented by using risk
assessment.
Question 18:
What are the
requirements on a regular evaluation of the audit trail?
Best Answer: Regularly
would also be every ten years. The period of time must be substantiated by
means of the process risk and documented.
Example:
Part of the periodic review or in the case of a batch release, part of the
system’s event log, and therefore at every release.
Question 19:
What shall be done
in the case of legacy systems without audit trail?
Best Answer: First
of all, it must be clarified whether the data can be changed at all (e.g.: electronic
recorders or SPS). If not, this should be the reasoning within the risk
assessment for the audit trail not being necessary.
Define
in an SOP that each change has to be documented e.g. in a logbook and verified
by
a
second person.
Question 20:
Is a “paper-based”
audit trail also possible?
Best Answer: Not
with a new system. If a system is introduced today, it must comply with the
requirements of Annex 11.
An
exemption are legacy systems, though. In the case of legacy systems this can be
regulated by an SOP if it has been checked beforehand that there is no other
possibility.
“Trust but Verify “ Ronald Re
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