Good Documentation Practice
ALCOA+ data integrity and record governance.
What this page does not claim
Educational orientation — not a determination of regulatory applicability, compliance, validation scope, or organizational approval.
WHAT IT GOVERNS
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.
WHY IT MATTERS
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.
KEY FOCUS AREAS
The ALCOA+ principles
Records that are attributable, legible, contemporaneous, original, and accurate — plus complete, consistent, enduring, and available — as the working definition of trustworthy data.
Contemporaneous recording & review
Recording at the time of the activity and independent second-person review, so entries are neither reconstructed after the fact nor self-certified.
Audit trails & electronic records
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.
Record retention & archival
Controlled retention, protection from alteration or loss, and retrievability for the full required lifetime of the record.
STANDARDS SPEQ DECODES · 6
Open the full library →WHAT INSPECTORS LOOK AT
- 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
RELATED DISCIPLINES
GDocP: frequently asked questions
Reference answers on Good Documentation Practice — what it governs, what regulations define it, and what it requires.
What is Good Documentation Practice (GDocP)?
GDocP governs how GxP records and data are created, reviewed, corrected, stored, and retained across both paper and electronic systems. It is the data-integrity discipline underneath every other GxP record — the working principle that if something isn’t documented, it didn’t happen, and if the documentation can’t be trusted, the quality claims built on it can’t be either.
What is ALCOA+?
ALCOA+ is the set of data-integrity principles at the core of GDocP. Records must be Attributable, Legible, Contemporaneous, Original, and Accurate — plus Complete, Consistent, Enduring, and Available. Together they form the working definition of trustworthy GxP data.
What does GDocP require for audit trails and corrections?
GDocP requires contemporaneous recording at the time of the activity and independent second-person review. For electronic records, secure, time-stamped audit trails must capture who did what and when, and be reviewed as part of the record. Corrections must be made so the original entry stays legible, with the reason justified.