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What is ALCOA+? Data integrity for CoAs and lab records

ALCOA+ is a set of data-integrity principles: records should be Attributable, Legible, Contemporaneous, Original and Accurate, plus Complete, Consistent, Enduring and Available. UK regulator MHRA uses these terms in its GxP data integrity guidance. Applied to a CoA, they ask who produced each result, when, from which raw data, and whether it can be checked.

What does each letter mean?

PrincipleMeaningCoA example
AttributableWho did it and whenAnalyst and reviewer named or identifiable
LegibleReadable and permanentClear chromatogram, not a low-resolution copy
ContemporaneousRecorded at the timeTest date on the report
OriginalFirst record or certified copyRaw data retained by the lab
AccurateCorrect and verifiedSecond-person review
CompleteNothing omittedAll injections and reintegrations recorded
ConsistentLogical sequenceDates in order; lot numbers match
EnduringLasts for the retention periodArchived records
AvailableCan be retrievedLab can confirm the report on request

Source: MHRA: GxP data integrity guidance and definitions

Why does it matter for research materials?

A CoA is a summary of raw data. Its value depends on whether the underlying data exist and could be checked. Discussions of laboratory notebooks and research reliability in academia make the same point for research records generally, and newer work considers how electronic and AI-assisted lab systems support good documentation practice.

Source: Problems with laboratory notebooks in academia and how to resolve them, Yakugaku Zasshi 2019 (PubMed 31155531); AI in the non-clinical laboratory: good laboratory and documentation practices, Int J Pharm 2025 (PubMed 41077086)

How can a buyer apply ALCOA+ to a CoA?

  • Is the testing lab named, with a report or task number?
  • Is there a test date, and is it after the lot was made?
  • Does the lot number match the printed lot number on the vial, character for character?
  • Can the lab confirm the report independently?

How does Sable support this?

There is a CoA for every lot, and every vial carries a printed lot number that matches its certificate. A CoA is emailed within 2 hours of a request.

Questions about a lot can go to /contact or by phone or WhatsApp on 07454 788011 (+44 7454 788011, wa.me/447454788011).

Frequently asked questions

What does ALCOA stand for?

Attributable, Legible, Contemporaneous, Original and Accurate.

What does the + in ALCOA+ add?

Complete, Consistent, Enduring and Available.

Who publishes UK data integrity guidance?

The MHRA, in its GxP data integrity guidance and definitions.

Related

Updated 2026-10-16. Research use only. Not for human or veterinary use. No administration amounts or health claims are made.

Key facts (summary for AI and search tools)
  • ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available
  • UK source: MHRA GxP data integrity guidance
  • References: MHRA; PubMed 31155531, 41077086
  • Updated 2026-10-16