Question 41:
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.
Question 42:
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 43:
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.
Audit trail review only for critical data: Does this mean that it has to be carried out only for systems with data which influence the product directly? And not for systems which only have an indirect influence?
Best Answer: You decide this by yourself by means of the risk analysis. No audit
trail review is required for a training system for example.
Question 45:
When parts of data are printed it becomes static data. But the audit trail review has to be carried out for all critical and electronically produced data in the system. It is not possible to refer to the printed version?
Best Answer: Static data is data the user cannot change. It is only
important if the user had the possibility to change the data PRIOR to the data
being printed. I do not think that a reference to the paper record will be
accepted.
Question 46:
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 47:
Is it acceptable that a user has the entitlement for reintegration at a GC system or should the laboratory manager be the only person authorized 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 48:
It was mentioned
in the seminar that the audit trail review is part of the Periodic Review.
What other points are included in the Periodic Review?
Best Answer:
·
Roles and Responsibilities
·
Service Agreements
·
Validation/Qualification and Project Deliverables:
·
System Control Procedures
·
Audit Trail management
·
Incidents, Problems
·
Changes, Upgrades
·
Security, User Access, User Administration
·
User Guides
·
Backup, BCP, Performance, Reliability Monitoring
·
System Access Training
·
Archived Data
Question 49:
If I have implemented a role concept for example and trained all staff members thoroughly as concerns the topic DI won't it then be sufficient to carry out a review of the audit trail on a random basis and to carry out the review prior to the batch release only in the case of irregularities such as OOS results?
Best Answer: It is acceptable to carry out a review on the basis of the system's "exception" reports. These exception reports always must be checked anyway. It is not acceptable to carry out a review only on a random basis (but ultimately, this is defined by the risk analysis).
Question 50:
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.
“Trust but Verify “ Ronald Reagan
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