Regulayer / The 143 laws / Pharma & life sciences
MHRA · GxP data integrity
ALCOA+ and audit-trail review as a governance duty.
Instrument: Regulatory guidance, nonbindingApplies to: GxP-regulated organisations (UK).
What the signed record shows
That the record was made by an identified person at the time of the action, and has not changed since.
The proof is a signed, tamper-evident record. Anyone can check it, free, without an account, and nothing has to leave the building to make it. Evidence, not a promise.
Citation: MHRA GxP Data Integrity Guidance and Definitions, March 2018
What to do about it
Keep the evidence this asks for, as the work happens.
A consequential AI-proposed action is checked against the human authority in force at that moment, and the decision leaves a signed record that a third party can verify independently, offline, without Regulayer. It runs inside your own environment and nothing has to leave it.
Life sciences: how the control worksOr verify a real record, free →
Part of the Regulayer proof catalogue: 143 laws and standards, one sealed engine. This page is a product description, not legal advice.
What the guidance requires, in outline
Medicines and Healthcare products Regulatory Agency, GxP Data Integrity Guidance and Definitions, March 2018. The reference that defines the vocabulary a UK inspector uses:
- ALCOA and ALCOA+
- Data should be attributable, legible, contemporaneous, original and accurate, and in the extended form also complete, consistent, enduring and available. Attributable is first, and it is the one AI-assisted work puts under pressure.
- Attributable, specifically
- It must be possible to identify the individual who performed the recorded action. A record that identifies an account rather than a person, or a person who did not in fact decide, does not satisfy this.
- Contemporaneous
- The record is made at the time of the activity, not reconstructed later from other material.
- Audit-trail review as a duty
- Reviewing audit trails is treated as part of data governance rather than an optional capability of the system.
Guidance rather than statute, and it applies across GxP rather than to manufacturing alone. It is included because ALCOA+ is the language quality functions actually think in, and because contemporaneous attribution is exactly what breaks when a model drafts and a person signs.
Built against the primary text published by the MHRA. Verified 17 August 2026.
