ALCOA+

Attributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring, Available

ALCOA was articulated by FDA in the 1990s as the minimum attributes of a reliable GxP record: Attributable (you can tell who recorded it), Legible (it can be read, now and in twenty years), Contemporaneous (recorded when the activity happened), Original (the first capture, or a verified true copy), and Accurate (it reflects what actually occurred).

The “+” attributes, formalised by MHRA and PIC/S, close the gaps the original five left open. Complete — nothing omitted, including repeats and failures. Consistent — sequences and timestamps make sense against each other. Enduring — the medium survives the retention period. Available — it can be retrieved for review or inspection throughout that period.

The attributes work as a system, not a menu. A result that is accurate but written up a shift later fails Contemporaneous. A chromatogram reprocessed until it passes fails Original and Accurate. An audit trail that was switched off fails Complete. Inspectors read them together, which is why a single weak attribute can undermine an otherwise sound record.

• —Attributable · Legible · Contemporaneous · Original · Accurate — the original five.
• —Plus: Complete · Consistent · Enduring · Available.
• —Applies to paper and electronic records equally, for the full retention period.
• —Complete includes failures, repeats, and aborted runs — not just the results you liked.
• —The attributes are assessed as a system; one weak attribute undermines the record.

MHRA GXP Data Integrity Definitions and Guidance for Industry (2018); PIC/S PI 041-1; WHO TRS 1033 Annex 4; underpins 21 CFR Part 11, 21 CFR 211.194, and EU GMP Chapter 4 / Annex 11.