Data integrity PIC S

Check that access to archived documents is restricted to authorised
personnel ensuring integrity of the stored records.
Check for the presence of records of accessing and returning of
records.
The storage methods used should permit efficient retrieval of
documents when required.
2. Expectation
All hardcopy quality records should be archived in:
- secure locations to prevent damage or loss,
- such a manner that it is easily traceable and retrievable, and
- a manner that ensures that records are durable for their archived life.
Specific elements that should be checked when reviewing records:
Check for the outsourced archived operations if there is a quality
agreement in place and if the storage location was audited.
Ensure there is some assessment of ensuring that documents will still
be legible/available for the entire archival period.
In case of printouts which are not permanent (e.g. thermal transfer
paper) a verified (‘true’) copy should be retained.
Verify whether the storage methods used permit efficient retrieval of
documents when required.
3. Expectation
All records should be protected from damage or destruction by:
- fire;
- liquids (e.g. water, solvents and buffer solution);
- rodents;
- humidity etc; and.
- unauthorised personnel access, who may attempt to amend, destroy
or replace records.
Specific elements that should be checked when reviewing records:
Check if there are systems in place to protect records (e.g. pest
control and sprinklers).
Note: Sprinkler systems should be implemented according to local
safety requirements; however, they should be designed to prevent
damage to documents, e.g. documents are protected from water.
Check for appropriate access controls for records.
8.11 Disposal of original records or true copies
8.11.1 A documented process for the disposal of records should be in place to
ensure that the correct original records or true copies are disposed of after
the defined retention period. The system should ensure that current records
are not destroyed by accident and that historical records do not inadvertently
make their way back into the current record stream (e.g. historical records
confused/mixed with existing records.)
PI 041-1 30 of 63 1 July 2021