Data integrity PIC S

Where appropriate, the reason for the correction should be clearly recorded
and verified if critical.
Initial and date the change made.
Specific elements that should be checked when reviewing records:
Check that the original data is readable not obscured (e.g. not
obscured by use of liquid paper; overwriting is not permitted).
If changes have been made to critical data entries, verify that a valid
reason for the change has been recorded and that supporting
evidence for the change is available.
Check for unexplained symbols or entries in records.
2. Expectation
Corrections should be made in indelible ink.
Specific elements that should be checked when reviewing records:
Check that written entries are in ink, which is not erasable, and/or will
not smudge or fade (during the retention period).
Check that the records were not filled out using pencil prior to use of
pen (overwriting).
8.8 Verification of records (secondary checks)
Item When and who should verify the records?
1. Expectation
Records of critical process steps, e.g. critical steps within batch records,
should be:
- reviewed/witnessed by independent and designated personnel at the
time of operations occurring; and
- reviewed by an approved person within the production department before
sending them to the Quality unit ; and
- reviewed and approved by the Quality Unit (e.g. Authorised Person /
Qualified Person) before release or distribution of the batch produced.
Batch production records of non-critical process steps is generally reviewed
by production personnel according to an approved procedure.
Laboratory records for testing steps should also be reviewed by designated
personnel (e.g.: second analysts) following completion of testing. Reviewers
are expected to check all entries, critical calculations, and undertake
appropriate assessment of the reliability of test results in accordance with
data-integrity principles.
Additional controls should be considered when critical test interpretations are
made by a single individual (e.g. recording of microbial colonies on agar
PI 041-1 27 of 63 1 July 2021