1. Are
the analytical data emerging in the course of the validation of analytical tests
critical data?
Solution: No, since these data are released with the completion of the validation
process and it only presents the basis for future analyses. Therefore
there is only an indirect criticality; no audit trail review is required.
2. The
calibration of equipment influences the correctness of data. Does this mean
that the calibration is critical?
Answer: No, Since the calibration does not influence the patient safety directly,
hence audit trail review is not mandatory, however it is nice to be provided.
4. Is the
audit trail review prior to the release of each batch a regulatory requirement
or is it only recommended so far?
Answer: Yes, Audit trial review is must based on Annex 11.Audit inspectors
consider the release of commercial batches to be the most critical process of
all.
5. Hybrid
systems: No audit trail retrofitting possible. What can be done?
Answer: First of all I would clarify all other criteria (access, user/admin
profile, safety). How critical is this data? Plan a replacement according to
the classification of the criticality if the data is critical.
6.
Role concept: Is a user allowed to carry out a reintegration?
Answer:
No, To carry out any reintegration it should be authorized by Head of
Department (QC/ARD) and later on approved by competent authorities like QA. The
documentation should include relevant reason for reintegration, further
approved by both QA and QC.
7. Is it
possible that the admin and the user being the same person?
Answer: In short NO, but in certain conditions, this is possible but it needs
to be clearly defined in a SOP. Providing guarantee by means of an SOP that the
admin account will NOT be used operational use.
8. Process
validation data are category 3 data – therefore no audit trail review is
required. Answer: As you have stated correctly, validation data have the
criticality of category 3.
It is very unlikely that the user will carry out changes since there is no
reason for falsification – in contrast to the batch release.
9. Must the report for a review of the audit trail be generated by the system itself?
Answer: Yes, Strictly speaking, the audit trail must be generated by the system itself.
(Updated on 12/20/2020)