Data integrity PIC S

- Data should be entered in a specified format that is controlled by the
software, validation activities should verify that invalid data formats
are not accepted by the system.
- All manual data entries of critical data should be verified, either by
a second operator, or by a validated computerised means.
- Changes to entries should be captured in the audit trail and
reviewed by an appropriately authorised and independent person.
For automated data capture: (refer also to table 9.3)
- The interface between the originating system, data acquisition and
recording systems should be validated to ensure the accuracy of
data.
- Data captured by the system should be saved into memory in a
format that is not vulnerable to manipulation, loss or change.
- The system software should incorporate validated checks to ensure
the completeness of data acquired, as well as any relevant
metadata associated with the data.
Potential risk of not meeting expectations/items to be checked
Ensure that manual entries of critical data made into computerised
systems are subject to an appropriate secondary check.
Validation records should be reviewed for systems using automated
data capture to ensure that data verification and integrity measures
are implemented and effective, e.g. verify whether an auto save
function was validated and, therefore, users have no ability to
disable it and potentially generate unreported data.
2. Expectation
Any necessary changes to data should be authorised and controlled in
accordance with approved procedures.
For example, manual integrations and reprocessing of laboratory results
should be performed in an approved and controlled manner. The firm’s
quality unit should establish measures to ensure that changes to data are
performed only when necessary and by designated individuals. Original
(unchanged) data should be retained in its original context.
Any and all changes and modifications to raw data should be fully
documented and should be reviewed and approved by at least one
appropriately trained and qualified individual.
Potential risk of not meeting expectations/items to be checked
Verify that appropriate procedures exist to control any
amendments or re-processing of data. Evidence should
demonstrate an appropriate process of formal approval for the
proposed change, controlled/restricted/defined changes and
formal review of the changes made.
PI 041-1 48 of 63 1 July 2021