Data integrity PIC S

4. Expectation
Documents should be stored in a manner which ensures appropriate version
control.
Master documents should contain distinctive marking so to distinguish the
master from a copy, e.g. use of coloured papers or inks so as to prevent
inadvertent use.
Master documents (in electronic form) should be prevented from
unauthorised or inadvertent changes.
E.g.: For the template records stored electronically, the following precautions
should be in place:
- access to master templates should be controlled;
- process controls for creating and updating versions should be clear
and practically applied/verified; and
- master documents should be stored in a manner which prevents
unauthorised changes.
Potential risk of not meeting expectations/items to be checked
Inappropriate storage conditions can allow unauthorised
modification, use of expired and/or draft documents or cause the loss
of master documents.
The processes of implementation and the effective communication,
by way of appropriate training prior to implementation when
applicable, are just as important as the document.
Item Distribution and Control
1. Expectations
Updated versions should be distributed in a timely manner.
Obsolete master documents and files should be archived and their access
restricted.
Any issued and unused physical documents should be retrieved and
reconciled.
Where authorised by Quality, recovered copies of documents may be
destroyed. However, master copies of authorised documents should be
preserved.
Potential risk of not meeting expectations/items to be checked
There may be a risk that obsolete versions can be used by mistake if
available for use.
2. Expectation
Document issuance should be controlled by written procedures that include
the following controls:
- details of who issued the copies and when they were issued;
PI 041-1 23 of 63 1 July 2021