Data integrity PIC S

- in the case of changes or modifications to data, the name of any
person authorising the change.
The audit trail should allow for reconstruction of the course of events
relating to the creation, modification, or deletion of an electronic record.
The system should be able to print and provide an electronic copy of the
audit trail, and whether viewing in the system online or in a hardcopy, the
audit trail should be available in a meaningful format.
If possible, the audit trail should retain the dynamic functionalities found in
the computerised system, (e.g. search functionality and ability to export
data such as to a spreadsheet).
Note: An audit trail should not be confused with a change control system
where changes may needed to appropriately controlled and approved
under a PQS.
Potential risk of not meeting expectations/items to be checked
Verify the format of audit trails to ensure that all critical and relevant
information is captured.
The audit trail should include all previous values and record
changes should not overwrite or obscure previously recorded
information.
Audit trail entries should be recorded in true time and reflect the
actual time of activities. Systems recording the same time for a
number of sequential interactions, or which only make an entry in
the audit trail, once all interactions have been completed, may not
be in compliance with expectations to data integrity, particularly
where each discrete interaction or sequence is critical, e.g. for the
electronic recording of addition of 4 raw materials to a mixing vessel.
If the order of addition is a critical process parameter (CPP), then
each addition should be recorded individually, with time stamps. If
the order of addition is not a CPP then the addition of all 4 materials
could be recorded as a single timestamped activity.
9.7 Data capture/entry for computerised systems
Item:
Data capture/entry
1. Expectation
Systems should be designed for the correct capture of data whether
acquired through manual or automated means.
For manual entry:
- The entry of critical data should only be made by authorised
individuals and the system should record details of the entry, the
individual making the entry and when the entry was made.
PI 041-1 47 of 63 1 July 2021