ALCOA and ALCOA+
ALCOA is the set of attributes every GMP record should have — Attributable, Legible, Contemporaneous, Original and Accurate — and ALCOA+ adds Complete, Consistent, Enduring and Available.
ALCOA is the set of attributes every GMP record should have — Attributable, Legible, Contemporaneous, Original and Accurate — and ALCOA+ adds Complete, Consistent, Enduring and Available.
Plain-English explanation, then the primary regulation it comes from.
Understanding alcoa and alcoa+
ALCOA began as a simple memory aid and became the common vocabulary regulators use to describe what a trustworthy record looks like. Its usefulness is diagnostic: when something feels wrong with a record and it is hard to articulate why, working through the nine attributes almost always locates the specific failure.
The attributes are not equally difficult. Legible and Available are largely solved by competent systems and archiving. Attributable, Contemporaneous and Original are where most real failures sit, because each is undermined by ordinary working habits rather than by bad intent — a shared login for convenience, a result written down at the end of a shift, a printout kept instead of the source file.
The '+' attributes were added because the original five left gaps that mattered. Complete addresses records where failing results or repeat injections were quietly omitted. Consistent addresses sequence and date-stamp integrity across a record set. Enduring addresses media that degrades or formats that become unreadable. Available addresses records that exist but cannot be retrieved within a reasonable time — which is also, in practice, an inspection-readiness problem.
- Attributable
- Who performed the action and when. Unique accounts and signatures; shared credentials defeat this outright.
- Legible
- Readable and permanent, for the full retention period. Includes readable electronic formats, not only handwriting.
- Contemporaneous
- Recorded at the time of the activity. Transcribing later from a note breaks this.
- Original
- The first capture, or a verified true copy. For dynamic records this means the source file, not a printout.
- Accurate
- Correct, truthful, and reflecting what actually happened — including the results nobody wanted.
- Complete
- All data, including repeats, failures and reprocessing history. Nothing silently omitted.
- Consistent
- Sequenced logically, with date and time stamps in expected order across the record set.
- Enduring
- Preserved on durable media in a readable format throughout the retention period.
- Available
- Retrievable for review and inspection throughout retention, within a reasonable time.
Common failure modes
- Attributability lost through shared or generic accounts — the most common single failure.
- Contemporaneity broken by recording on scrap paper and transferring to the record later.
- Originality lost by retaining a printout of a record that is inherently dynamic.
- Completeness lost by excluding a failing injection from the reported set without explanation.
Where this is written down
- MHRAMHRA — GxP Data Integrity Guidance and Definitions
Defines each attribute with worked expectations
- PIC/SPIC/S PI 041 — Good Practices for Data Management and Integrity
PI 041, on ALCOA+ across paper, hybrid and electronic systems
Read next
Data integrity
ReadTechnicalComputerised systems
ReadTechnicalAnnex 11 — computerised systems
ReadQualityOOS — out of specification
ReadLooking for a definition rather than an explanation? The GMP glossary covers the abbreviations in one line each.
Knowing the requirement is not the same as closing the gap
If you want to know where your site actually stands against this, the readiness score covers seven quality-system domains in twenty questions, and takes about ten minutes.