WHO Annex 5, Guidance on Good Data and Record Management Practices
Annex 5 was published as part of the WHO Technical Report Series No. 996, 2016. This represents a finalization of a draft document published for comment in September of 2015. Currently WHO and MHRA have published final guidance on the topic, and FDA recently published a draft guidance for comment. WHO initiated work in this area during a meeting in Geneva in April 2014.We provide the draft version of this guidance HERE for those who want to perform a deep-dive comparison on specific items.
Changes from the draft of September 2015 are primarily in re-organization of content and the addition of Appendix I titled ‘Expectations and examples of special risk management considerations for the implementation of ALCOA (-plus) principles in paper-based and electronic systems.’ The annex includes the tabulation of information on electronic and paper records, and examples of special risk management considerations that previously was included in a tabulation within the draft guidance. Content has also been expanded, in both the Appendix and in the document overall, increasing the length of Annex 5 by 10 pages over the 2015 draft.
Following are the changes between the 2015 draft guidance and the finalized 2016 Annex 5. This does not include minor changes in wording or reorganization of the same information.
- Section 2.3 in Aims and Objectives of the Guidance is new
- ALCOA-plus in the Glossary is new and reflects the more European view of ALCOA
- ‘Archivist’ in the Glossary is new
- ‘audit trail’ in the Glossary is expanded
- ‘control strategy’ in the Glossary is new
- ‘Corrective and preventive action’ in the Glossary is new
- ‘Good data and record management practices’ in the Glossary is new and reflects the new term for ‘good documentation practice’
- ‘Quality metrics’ in the Glossary is new
- Section 4.6 Management Governance is expanded
- Section 4.7 Quality Culture is expanded
- Section 4.12, providing examples of record keeping methodologies and systems is expanded
- Section 4.13 describing durability of data and record media is new
- Section 6.4 under Management Governance and Quality Audits is expanded
- Section 7.2 under Contracted Organizations, Suppliers and Service Providers is expanded.
- Section 7.6 under Contracted Organizations, Suppliers and Service Providers is new. This section addresses expectations where data and document retention is contracted to a third party.
- Sections 11.7 and 11.8 on Data Processing are new
- Section 11.15 and 16 on Data Retention and Retrieval are new