Data Integrity, Review and Record Retention

A record has value only when users can determine who created it, when it was created, what was observed and whether it was later changed. Data integrity protects the connection between the actual process and the release or corrective-action decision.

Measurements and observations should be recorded at the time of work in the authorised system. Transcription, summary worksheets and exported reports must preserve linkage to the original data and identify any transformation.

Paper corrections should not obscure the original entry. Electronic systems should control access and retain sufficient audit information to reconstruct significant changes, deletions, configuration changes and approvals.

Review should address missing data, abnormal trends, instrument status, alarms, deviations and required signatures rather than only confirm that fields contain text. Automated exception flags can help, but their configuration and omissions require verification.

Retention periods depend on product, shelf life, legal obligations, customer requirements and the purpose of the record. Records should remain readable, backed up where appropriate and retrievable within the time needed for investigation or recall.

Access roles, version control, backup, cybersecurity and migration controls become more important as systems grow. A simple home record still benefits from dated, unaltered observations, while regulated establishments must follow their jurisdiction-specific record rules.