WHO Guidance on Good Data and Record Management Practices
The WHO guidance on good data and record management practices (Technical Report Series No. 996, Annex 5, 2016) — the data-integrity reference the WHO Prequalification Programme applies. It sets out the ALCOA(-plus) attributes, data governance through quality risk management, and expectations for paper-based and electronic records across the whole data lifecycle.
What this does not cover
stated in the document's own scope- Sets data and record management expectations; the underlying manufacturing requirements remain in the WHO GMP texts such as TRS 986 Annex 2.
- Provides WHO guidance that binds only through national adoption or WHO Prequalification; it is not a statute in any jurisdiction by itself.
- Covers data governance and record reliability; the validation methodology for computerised systems as such is the province of dedicated CSV frameworks like GAMP 5.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
The WHO Guidance on Good Data and Record Management Practices (Technical Report Series No. 996, Annex 5, 2016) is the World Health Organization's data-integrity reference. It defines the ALCOA attributes — attributable, legible, contemporaneous, original, accurate — with the additional emphasis that records be complete, consistent, enduring, and available, and it builds data governance on quality risk management: controls proportionate to data criticality and risk across the whole data lifecycle. The guidance addresses management governance and quality audits, contracted organisations, training, good documentation practices, and the design and validation of both paper-based and electronic systems, and its appendix works through what each ALCOA(-plus) attribute demands of paper and electronic records side by side.
Scope & applicability
Organisations performing GxP activities assessed against WHO norms — notably manufacturers and laboratories in the WHO Prequalification Programme and jurisdictions that adopt WHO guidance as their national standard. Written to apply across GMP, GCP, and GLP records, paper and electronic alike.
Legal basis & how it acquires force
An annex to the fiftieth report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations, published in WHO Technical Report Series No. 996 (2016). WHO guidance is not itself law: it acquires force when national regulatory authorities adopt it, and operationally through the WHO Prequalification Programme, which assesses manufacturers and laboratories against WHO norms as a condition of supplying UN procurement agencies.
Document structure
| Part | Covers |
|---|---|
| Background, aims and glossary | Why the guidance exists, the activities it addresses, and the defined terms it uses |
| Principles | The ALCOA(-plus) attributes and the foundations of reliable records in a quality system |
| Quality risk management and management governance | Risk-proportionate data controls, leadership accountability for data reliability, and quality audits |
| Contracted organisations, suppliers and training | Extending data-management expectations to third parties and building personnel capability |
| Good documentation practices and system design | Expectations for creating, correcting, and maintaining records, and for designing and validating paper and electronic systems that assure data quality |
| Appendix 1 | Expectations and examples for implementing ALCOA(-plus) attributes in paper-based and electronic systems |
Key requirements
- Records meet the ALCOA(-plus) attributes: attributable, legible, contemporaneous, original, accurate — plus complete, consistent, enduring, and available
- Data governance built on quality risk management, with controls proportionate to data criticality and risk
- Management governance: leadership accountability for data reliability, supported by quality audits
- Contracted organisations, suppliers, and service providers covered by the data-management framework
- Good documentation practices and validated system design for both paper-based and electronic systems
- Data managed and protected across its full lifecycle, from creation through retention to disposal
Implementation tips
- Use Appendix 1 — the paper-vs-electronic expectations table per ALCOA attribute — as a gap-assessment checklist against your own systems
- Where a site supplies WHO-prequalified products, align the data-governance SOP vocabulary to this annex; it is the reference the assessment team works from
Revision notes
Adopted in WHO Technical Report Series No. 996 (2016). WHO later issued a broader Guideline on Data Integrity (TRS 1033, Annex 4, 2021) that builds on the same principles.
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
The guidance is the WHO member of the international data-integrity family, sharing the ALCOA(-plus) framework with the MHRA GxP Data Integrity Guidance, PIC/S PI 041, and FDA's CGMP data-integrity Q&A. It is deliberately cross-cutting — written to apply to GMP, GCP, and GLP records alike — and WHO later built on it with the Guideline on Data Integrity in TRS 1033, Annex 4 (2021).
WHO TRS 996, Annex 5: frequently asked questions
Quick answers to common questions about WHO TRS 996, Annex 5.
What does ALCOA-plus mean in the WHO guidance?
Records should be attributable, legible, contemporaneous, original, and accurate — ALCOA — with additional emphasis on being complete, consistent, enduring, and available. The guidance applies these attributes equally to paper-based and electronic records.
Who is assessed against WHO TRS 996 Annex 5?
Primarily manufacturers and laboratories participating in the WHO Prequalification Programme, plus organisations in jurisdictions whose national regulator adopts WHO norms. Many multinational quality systems also reference it as the cross-GxP data-integrity baseline.
How does the WHO guidance differ from the MHRA data-integrity guidance?
They share the ALCOA(-plus) framework and a cross-GxP scope. The WHO text is aimed at the global setting — including markets where WHO norms are the operative standard — and carries a detailed appendix contrasting paper and electronic expectations attribute by attribute; the MHRA document is built around definitions and data-governance expectations for MHRA-regulated organisations.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.