New WHO Draft on "Good Data and Record Management"

Recommendation

22-24 May 2024
Copenhagen, Denmark

IT / OT Infrastructure Qualification and Operation in a GMP Environment

After several FDA Warning Letters were issued in the last 2-3 years, regulatory authorities have set their focus on the data integrity topic - see also our News "Data Integrity: New Inspection Focus of the FDA." Both the PICS and the FDA are elaborating new guidelines on the topic; the English MHRA has already published an own Guideline - see also our News "GMP Data Integrity: New MHRA Guideline". 

Now, the WHO has released the draft of a guideline - after a one-year development phase - "Good Data and Record Management Practices" which can be commented on until 30 November 2015. 

A substantial part of the decisions taken by the authorities with regard to the regulated industry are based on dossiers. For this reason, their data have to meet the ALCOA principles (Accurate / Legible / Contemporaneous / Original / Attributable). Although those principles aren't new, an increasing number of observations with regard to "Good Data Management" in the area of GMP, GCP and GLP have been made during inspections in the last years. The reasons for this are manifold.

The present WHO draft on "Good Data Management" should bring together all the existing normative principles and close the gaps left behind in the current guidelines. The focus is on those principles which are already listed in existing WHO guidelines and which have an influence on data integrity and reliability.

The draft itself is sectioned as follows: 

• Introduction and background
• Aims and objectives of this Guidance
• Glossary
• Principles
• Quality risk management to ensure Good Data Management
• Management governance and quality audits
• Contracted organizations, suppliers, and service providers
• Training in Good Data and Record Management
• Good Documentation Practice
• Designing Systems to assure data quality and reliability
• Managing data and records across the data lifecycle
• Addressing data reliability issues
• References and further reading

Delegates and former delegates of ECA events as well as ECA members have access to the Members Area where the WHO Guidance on Good Data and Record Management Practices can be downloaded.