Validatingcomputerizedsystem com

Consideration should be given to the system creating a complete record of all entries and amendments (an "audit trail"). Alterations to a system or to a computer program should only be made in accordance with a defined procedure which should include provision for validating, checking, approving and implementing the change.Such an alteration should only be implemented with the agreement of the person responsible for the part of the system concerned, and the alteration should be recorded. Data should be secured by physical or electronic means against wilful or accidental damage, and this in accordance with item 4.9 of the Guide.

Any alteration to an entry of critical data should be authorised and recorded with the reason for the change.

The introduction of computerised systems into systems of manufacturing, including storage, distribution and quality control does not alter the need to observe the relevant principles given elsewhere in the Guide.

Where a computerised system replaces a manual operation, there should be no resultant decrease in product quality or quality assurance.

It specifically does not require the 21CFR11 requirement for record retention for tracebacks by food manufacturers.

Most food manufacturers are not otherwise explicitly required to keep detailed records, but electronic documentation kept for HACCP and similar requirements must meet these requirements.

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