Advisory Document on GLP Data Integrity
The OECD Working Party on GLP's advisory document on data integrity (Series on Principles of GLP and Compliance Monitoring No. 22, September 2021). It applies data-integrity thinking to the nonclinical safety-study world: a risk-based approach built on data criticality, data risk, and the data lifecycle, with defined responsibilities for test facility management, the study director, study personnel, and quality assurance.
What this does not cover
stated in the document's own scope- Covers GLP studies and study phases at test facilities and test sites; manufacturing and clinical data integrity are addressed by the GMP and GCP frameworks, not this document.
- An advisory document interpreting the OECD Principles of GLP; the binding obligations come from national GLP legislation implementing those principles.
- Addresses data integrity; the validation and lifecycle management of computerised systems as such is the subject of OECD Advisory Document No. 17.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
OECD Advisory Document No. 22, GLP Data Integrity, applies data-integrity thinking to the nonclinical safety-study world governed by the OECD Principles of Good Laboratory Practice. Published by the OECD Working Party on GLP in September 2021, it promotes a risk-based approach to managing study data built on three ideas — data criticality, data risk, and the data lifecycle — and asks facilities to understand their data flows end to end so the data that bear on GLP compliance and study reconstruction are identified and controlled. It devotes substantial attention to the responsibilities of the roles GLP defines — test facility management, the study director, study personnel, and quality assurance — and to electronic data capture systems, where most integrity questions now arise.
Scope & applicability
Test facilities and test sites conducting GLP studies or GLP study phases under the OECD Principles of GLP — the studies behind the Mutual Acceptance of Data system. Particular attention is given to electronic data capture systems.
Legal basis & how it acquires force
An advisory document in the OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring (No. 22, reference ENV/CBC/MONO(2021)26, published 20 September 2021). It interprets the OECD Principles of GLP, which member and adherent countries implement in national law — for example through the EU GLP Directives and national GLP compliance-monitoring programmes — under the OECD Mutual Acceptance of Data system, which obliges members to accept compliant studies from one another.
Document structure
| Part | Covers |
|---|---|
| Introduction and scope | Purpose of the advisory document and the GLP studies and study phases it addresses |
| Data integrity in the GLP framework | How integrity expectations flow from the OECD Principles of GLP and support study reconstruction |
| Roles and responsibilities | Data-integrity duties of test facility management, the study director, study personnel, and quality assurance |
| Risk-based data management | Data criticality, data risk, the data lifecycle, and understanding data flows |
| Electronic data capture systems | Integrity expectations for the computerised systems that capture and hold study data |
Key requirements
- A risk-based approach to data management driven by data criticality, data risk, and the data lifecycle
- Defined data-integrity responsibilities for test facility management, the study director, study personnel, and QA
- Understanding and documentation of data flows so GLP-impacting data are identified and controlled
- Controls for electronic data capture systems proportionate to their role in study reconstruction
Implementation tips
- Map each study-critical data flow end-to-end (capture → processing → reporting → archive) before assigning controls — the document's lifecycle framing assumes you know where the data travels
- Use it beside OECD Advisory No. 17 (computerised systems): No. 17 governs the systems, No. 22 governs the integrity of the data they hold
Revision notes
Published 20 September 2021 (ENV/CBC/MONO(2021)26). It closes the GLP-specific gap left between the cross-GxP MHRA guidance and the GMP-scoped FDA Q&A.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
No. 22 completes the international data-integrity family on its nonclinical axis: the MHRA guidance spans all GxP disciplines, the FDA Q&A interprets drug CGMP, PIC/S PI 041 serves GMP/GDP inspectorates, and this document serves GLP test facilities and their monitoring authorities. Within the OECD series it pairs with Advisory Document No. 17 on the application of GLP principles to computerised systems — No. 17 governs the systems, No. 22 the integrity of the data they hold — and both operate under the Mutual Acceptance of Data framework.
OECD GLP Advisory No. 22: frequently asked questions
Quick answers to common questions about OECD GLP Advisory No. 22.
What does OECD Advisory Document No. 22 cover?
A risk-based approach to data integrity in GLP studies — built on data criticality, data risk, and the data lifecycle — with defined responsibilities for test facility management, the study director, study personnel, and QA, and particular attention to electronic data capture systems.
Is Advisory Document No. 22 legally binding?
Not directly. It is an OECD advisory document interpreting the Principles of GLP. Its force comes through the national legislation that implements those principles and through the OECD Mutual Acceptance of Data system, under which compliance-monitoring authorities assess facilities against the OECD framework.
How does No. 22 relate to OECD Advisory Document No. 17?
They are companions. No. 17 (2016, with a 2023 cloud-computing supplement) applies GLP principles to computerised systems — their validation and operation. No. 22 (2021) addresses the integrity of the data those systems capture and hold. A GLP facility using electronic data capture needs both.
Why does GLP need its own data-integrity document?
Because GLP's central obligation is study reconstruction: a nonclinical safety study must be reconstructable from its records years later, under the study director's single point of control. General GMP data-integrity guidance does not map cleanly onto that structure, so the Working Party on GLP issued guidance in GLP's own terms.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.