What does PIC/S · PI 041-1 cover?

Data management and integrity in regulated GMP and GDP environments. It applies to: GMP and GDP inspectorates and the sites they inspect.

What does the Regulayer pack for PIC/S · PI 041-1 prove?

That the record was made at the time by an identified person, and can be checked independently. The record is signed and tamper-evident, and anyone can verify it free, without an account.

Regulayer™ / The 151 laws / Pharma & life sciences

PIC/S · PI 041-1

Data management and integrity in regulated GMP and GDP environments.

Instrument: Inspectorate standardApplies to: GMP and GDP inspectorates and the sites they inspect.

What the signed record shows

That the record was made at the time by an identified person, and can be checked independently.

The proof is a signed, tamper-evident record. Anyone can check it, without an account, and nothing has to leave the building to make it. Evidence, not a promise.

Citation: PIC/S PI 041-1, effective 1 July 2021

In the same family

MHRA · GxP data integrityALCOA+ and audit-trail review FDA · Data integrity and CGMP Q&AAudit-trail review expectations EU GMP · Annex 11Computerised-systems integrity FDA · 21 CFR Part 11Electronic records & signatures

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 works Or verify a real record →

Part of the Regulayer™ proof catalogue: 151 laws and standards, one sealed engine. This page is a product description, not legal advice.

What the standard sets out

Pharmaceutical Inspection Co-operation Scheme, Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments, PI 041-1, effective 1 July 2021. The harmonised international reference inspectors carry:

Harmonised data-integrity expectations: A single reference across participating inspectorates, which is why it travels further than any one national guidance.
Audit-trail review expectations: Set out as a governance activity with defined frequency and responsibility, not as a system feature that merely exists.
Data governance across the lifecycle: Expectations attach to how data is generated, processed, retained and retrieved, not only to how it is stored.
Risk-based application: Depth of control is expected to follow the risk the data carries to product quality and patient safety.

An inspectorate standard rather than a statute. It is here because it is the document most likely to be in the room during an inspection, and because its audit-trail review expectations are the practical form the attribution question takes.

Built against the primary text published by PIC/S. Verified 17 August 2026.

This is the duty on the business. For what a lawyer in Europe must disclose about using AI in a filing, see Europe: the EU AI Act, the CCBE guides, and what Germany tells its lawyers.