Question 01:
When does an audit trail begin?
Best Answer: Audit Trail initiation requirements
differ for data vs. textual materials.
For data: If you are generating,
retaining, importing or exporting any electronic data, the
Audit Trail begins
from the instant the data hits the durable media.
For textual documents: if the
document is subject to approval and review, the Audit Trail begins upon
approval and release of the document.
Question 02:
Should execution of a signature be audit trailed?
Best Answer: Yes, execution of a signature must
be audit trailed.
Question 04 :
For clinical data management systems, where does the
audit trail begin after first entry or after the data has been verified and
uploaded to the data management system?
Best Answer: In GMP there are mandated to comply
with 21 CFR Part 11, which requires tracking the activity and ownership of
electronic clinical data in audit trails.
If you are using Remote Data Entry
(RDE) software for data entry, or especially a Web-based RDE, you need to
exercise due diligence to protect your data from inadvertent or malicious
changes.
Question 04:
Is the audit trail review prior to the release of each batch a
regulatory requirement or is it only recommended so far?
Best Answer: Annex
11 requires the audit trail review. Inspectors consider the release of batches
to be the most critical process of all.
Question 05 :
In Hybrid systems No audit trail retrofitting possible. What
can be done?
Best 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 (= priority) if the data is critical.
Question 06 :
It is useful to review the "windows event viewer" for
GxP devices?
Best Answer: This is a
good idea but it will probably not be realistic as too many events would be
reported.
Its use would anyway only be worth considering for systems which
save data locally, and this isn't done by many modern systems anymore.
Question 07:
Must the report for a review of the audit trail be generated by
the system itself? Or is it possible to use another system which is better
suited for carrying out analyses?
Best Answer: Strictly
speaking, the audit trail must be generated by the system itself ("system
generated audit trail"). Which other system do you have in mind?
Question 08:
May the Head of Laboratory have admin rights for example to
carry out the audit trail review?
Best Answer: Yes, as
long as she/he does not operationally process analyses herself/himself.
Question 09:
Do you know a system that fulfils all requirements for the
audit trail function of a CDS?
Best Answer: So far
there are hardly any systems on the market which allow to carry out the review
with a minimum effort. Unfortunately, this is also true for modern systems as
Empower 3.
Question 10:
Whose job is it to carry out the audit trial review in the
laboratory?
Best Answer: This can be
a colleague. The FDA requires "Quality Unit" (=QA) in the Draft
Guideline. All other Draft Guidelines allow for a peer review.
“Trust but Verify “ Ronald Re
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