1. May we define entries in our
CDS such as standard concentrations, densities, dilution factors, hence
parameters used for the quantification of content and purity as static data? Or
are these entries also part of the dynamic data such as the (re)integration of
peaks?
Answer: In my
opinion this is also dynamic data the user can influence or change.
2. Is it possible to shorten the audit
trail review by taking the status of the analytical sequence and controlling
the recorded parameters (such as concentration of the standards, at the end of
the analysis and by stating that all changes and corrections carried out in the
meantime are part of the analysis and evaluation and must consequently not be
commented?
Answer: In my view this is acceptable as long as a control is carried out
and confirmed by a second person.
3. 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?
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
4. 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?
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).
5. 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?
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. (Updated 20/12/2020)
