Good Documentation Practice

Good Documentation Practice governs how GxP records and data are created, reviewed, corrected, stored, and retained — the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available) applied across both paper and electronic systems. It is the data-integrity discipline underneath every other GxP record.

Data integrity is the foundation every other control rests on: in a GxP world, if it isn’t documented, it didn’t happen — and if the documentation can’t be trusted, none of the quality claims built on it can be either. Data-integrity failures (backdating, shared logins, deleted results, uncontrolled audit trails) are among the most severe findings a regulator can issue, up to import alerts and consent decrees.

Records that are attributable, legible, contemporaneous, original, and accurate — plus complete, consistent, enduring, and available — as the working definition of trustworthy data.

Recording at the time of the activity and independent second-person review, so entries are neither reconstructed after the fact nor self-certified.

Secure, time-stamped audit trails that capture who did what and when, reviewed as part of the record — the electronic equivalent of an uncorrected logbook.

Controlled retention, protection from alteration or loss, and retrievability for the full required lifetime of the record.

• ›Audit-trail review — is it enabled, complete, and actually reviewed?
• ›Contemporaneousness of entries and how corrections are made and justified
• ›Access controls, unique logins, and segregation of duties
• ›Data governance policy and the lifecycle of both paper and electronic records

Derived from the 3 standards SPEQ decodes for this discipline.