Data integrity means that the data behind every GMP decision — a test result, a batch record entry, a release signature — is complete, consistent and accurate, and stays that way from the moment it is created until it is destroyed at the end of its retention period. It applies equally to paper, electronic and hybrid records.
Good data integrity rests on three things: data governance (policies, ownership and risk assessment of data flows), a quality culture where people report errors rather than hide them, and technical controls such as unique logins, audit trails, access rights and secure storage.
Why it matters in GMP
Data integrity failures have driven many warning letters, import alerts and non-compliance statements over the last decade. The FDA’s guidance on data integrity and cGMP, the MHRA GxP data integrity guidance and PIC/S guidance PI 041 all expect manufacturers to understand their data flows, review audit trails and design systems so that falsification is difficult and detectable.
- Map critical data flows and assess the risk at each step.
- Review audit trails as part of routine record review, not only after a problem.
- Make second-person review of critical raw data part of the process.
How Swat iQua Suite handles it
Swat iQua Suite combines a complete, cross-module audit trail with periodic, risk-based audit trail review. The review automatically flags deletions and voids, privileged changes, configuration changes, after-hours activity and changes made after approval, and a finding can raise a CAPA. Second-person raw data review enforces that the reviewer is not the analyst, with a finding raising a deviation.