Data integrity PIC S

and that they maintain access to the necessary software to enable
review of the archived data.
Where external or third party facilities are utilised for the archiving
of data, these service providers should be subject to assessment,
and all responsibilities recorded in a quality technical agreement.
Check agreements and assessment records to verify that due
consideration has been given to ensuring the integrity of archived
records.
4. Expectation
It should be possible to print out a legible and meaningful record of all the
data generated by a computerised system (including metadata).
If a change is performed to records, it should be possible to also print out
the change of the record, indicating when and how the original data was
changed.
Potential risk of not meeting expectations/items to be checked
Check validation documentation for systems to ensure that systems
have been validated for the generation of legible and complete
records.
Samples of print-outs may be verified.
5. Expectation
Procedures should be in place that describe the process for the disposal of
electronically stored data. These procedures should provide guidance for
the assessment of data and allocation of retention periods, and describe
the disposal of data that is no longer required.
Potential risk of not meeting expectations/items to be checked
Check that the procedures clearly stipulate the conditions for the
disposal of data, and that care is taken to avoid the inadvertent
disposal of required data during its lifecycle.
9.10 Management of Hybrid Systems
Item:
Management of Hybrid Systems
1. Hybrid systems require specific and additional controls in reflection of their
complexity and potential increased vulnerability to manipulation of data. For
this reason, the use of hybrid systems is discouraged and such systems
should be replaced whenever possible.
Each element of the hybrid system should be qualified and controlled in
accordance with the guidance relating to manual and computerised
systems as specified above.
PI 041-1 52 of 63 1 July 2021