1. How do you
justify the reintegration of chromatograms versus the method specification in
the audit trail?
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.
2. 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?
Answer: You decide this by yourself by means of the risk analysis. No audit
trail review is required for a training system for example.
3. How or
where (guidance document) is it advisable to define raw data?
Answer: (Unfortunately) there is no uniform definition. This means you are
flexible to define this for your company.
4. 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?
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.
5. Can the
review of a printout of the drying temperature profile be considered to be part
of the audit trail review of the batch?
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.
6. Is
analytical data (raw data, metadata) from the validation of analytical
procedures classified as being non critical? In this case the audit trail
review would not be required.
Answer: The validation of analytical procedures precedes the daily analyses for
the batch release and constitutes the basis for them. The validation data is
released with a report. The audit trail review is not required. (updated on 20/12/2020)
