ALCOA+ applied to maintenance records
ALCOA+ is nine data-integrity attributes used in GMP guidance to evaluate a record: attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available. ALCOA++ adds a tenth attribute (traceable). It appears in EMA’s 2023 clinical-trials guideline and in the July 2025 consultation draft of the revised EU GMP Chapter 4, which has not been adopted.
It is the vocabulary used in PIC/S PI 041-1 (in force since July 2021) and WHO’s 2021 data integrity guideline.
The in-force GMP guidance cited here uses ALCOA+, and FDA’s drug CGMP data integrity guidance uses plain ALCOA.
For a maintenance record: attributable means you can identify who performed the work and when; contemporaneous means it was recorded as the work took place, not reconstructed afterward; enduring means the record survives for the whole period it is required. Three are usually the hard ones for a maintenance system: contemporaneous (written back at a desk an hour later), complete (evidence living in a phone camera roll instead of the record), and enduring (retention nobody actually implemented).
Where MYREX stands: attribution is to the authenticated session rather than to the person physically at the device; timestamps are computed server-side rather than taken from the device clock; and enduring is the one we do not address at all, because there is no retention or archival capability in the product today.
Sources and notes
PIC/S PI 041-1, Good Practices for Data Management and Integrity, in force 1 July 2021 · WHO Technical Report Series No. 1033, Annex 4, Guideline on data integrity, 2021 · MHRA, ‘GXP’ Data Integrity Guidance and Definitions, Revision 1, March 2018 · EMA/INS/GCP/112288/2023 (ALCOA++) · European Commission, draft revised EudraLex Volume 4, Chapter 4, consultation July–October 2025 (ALCOA++).
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