Data integrity PIC S

plates). A secondary review may be required in accordance with risk
management principles. In some cases this review may need to be performed
in real-time. Suitable electronic means of verifying critical data may be an
acceptable alternative, e.g. taking photograph images of the data for
retention.
This verification should be conducted after performing production-related
tasks and activities and be signed or initialled and dated by the appropriate
persons.
Local SOPs should be in place to describe the process for review of written
documents.
Specific elements that should be checked when reviewing records:
Verify the process for the handling of production records within
processing areas to ensure they are readily available to the correct
personnel at the time of performing the activity to which the record
relates.
Verify that any secondary checks performed during processing were
performed by appropriately qualified and independent personnel, e.g.
production supervisor or QA.
Check that documents were reviewed by production personnel and
then quality assurance personnel following completion of operational
activities.
Item How should records be verified?
2. Expectation
Check that all the fields have been completed correctly using the current
(approved) templates, and that the data was critically compared to the
acceptance criteria.
Check items 1, 2, 3, and 4 of section 8.6 and Items 1 and 2 of section 8.7
Specific elements that should be checked when reviewing records:
Inspectors should review company procedures for the review of
manual data to determine the adequacy of processes.
The need for, and extent of a secondary check should be based on
quality risk management principles, based on the criticality of the data
generated.
Check that the secondary reviews of data include a verification of any
calculations used.
View original data (where possible) to confirm that the correct data
was transcribed for the calculation.
PI 041-1 28 of 63 1 July 2021