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Data integrity (ALCOA+) checklist

A working ALCOA+ assessment per the MHRA GxP DI guidance and PIC/S PI 041-1.

Complere Resource Library Excel workbookData integrityChecklist

ALCOA+ is easy to recite and hard to evidence. This checklist turns each attribute into an observable condition — what good looks like on the system in front of you — and records what you actually examined, so the assessment itself meets the standard it is applying.

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Data integrity ALCOA+ checklist — the Excel workbook you download, showing its attributes and columns

What the checklist covers

The workbook assesses nine ALCOA+ attributes plus three governance controls — one system or process per copy — each row pairing what good looks like with an evidence-examined column, an owner, and a Pass / Gap / N-A dropdown, plus an Instructions tab and a worked example.

All nine ALCOA+ attributes as observable, checkable conditions
Attributability: unique accounts, no shared logins on GMP actions
Original-record and true-copy handling, including dynamic data
Completeness: repeat tests, aborted runs and failures all present
Governance: DI policy, training, audit trail review, hybrid mapping

Frequently asked questions

What does ALCOA+ stand for?

Attributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring and Available. The MHRA GxP guidance and PIC/S PI 041-1 treat the full set as the working definition of trustworthy data, for paper and electronic records alike.

Does ALCOA+ apply to paper records too?

Yes — the attributes are format-neutral. Paper brings its own risks (legibility, loss, uncontrolled copies) and hybrid situations need the true record defined per data flow, which is why the checklist carries a dedicated hybrid-mapping row.

How is a data integrity assessment different from a Part 11 assessment?

Part 11 assesses a system's controls for electronic records and signatures; a DI assessment follows the data itself through its lifecycle, whatever the format. They overlap on audit trails and access control — we publish a separate checklist for each because inspectors ask for both.

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