Are you prepared for WHO draft guidance on Good Data and Record Management Practices?
By Deb Bartel,
This post was recently updated on September 19, 2018
In September 2015, the World Health Organization (WHO) published a draft guidance document focused solely on data integrity. This is due to recent increases in the number of inspection observations related to data management practices. These WHO recommendations are intended to ensure the integrity of both paper and electronic data and records. Share this with your team, so you can incorporate these practices into your procedures.
What’s new in this WHO Guidance document:
Definitions of Terms:
This draft guidance contains definitions of the following terms:
- Data Integrity
- Metadata
- Audit Trail
- Static and dynamic record formats
- Backup
- Computerized system
WHO Recommendations
The draft guidance also provides recommendations regarding system:
- Design and validation for data integrity
- Access restrictions
- Unique user logins
- Audit trail reviews
- Original records and true copies
- Lab system and data controls
- Electronic signatures
- Controls for IT suppliers and service providers (e.g., cloud)
- Periodic GDP training for employees and IT service providers
This document is open for comments through November 30, 2015. Contact information is in the document for where to direct your feedback.
Obtain a copy of the WHO Draft Guidance here: Guidance on Good Data and Record Management Practices
Do you need more help implementing these recommendations at your organization? Talk to our CSV experts about how you might be affected.
About the Author:
Deb Bartel is a long-time leader of software quality and information system initiatives. Her expertise is built on 25 years of work in pharmaceuticals, medical device, chemicals, and textile manufacturing industries. She is a Principal at Praxis Life Sciences, where she is responsible for the Computer System Validation (CSV) and Software Quality Assurance (SQA) practice.
Deb has trained hundreds of Life Sciences professionals in risk-based computer system validation.
Copyright Policy
Unless otherwise noted, Praxis Life Sciences, LLC is the legal copyright holder of all (written, multimedia and graphic) material on this website and it may not be used, reprinted, (partially) modified or published without written consent. A link to Validation Center must appear in all copies of any artwork or content, including articles and press releases.
You are welcome to share this article on social media so long as you link back directly to this post (providing the link). No copy & paste of this content will be allowed under any circumstances.
