Are you ready for the FDA guidance on Data Integrity and Compliance?
By Deb Bartel,
This post was recently updated on September 19, 2018
The FDA just published a new, draft guidance document on good manufacturing practices (cGMP) for drugs. This document is intended to address the frequent data integrity issues found during FDA inspection of pharmaceutical and API manufacturing sites.
What’s new in this draft FDA guidance document:
Clarifications & Definitions of Terms
This draft guidance contains clarifications and definitions for the terms like:
- data integrity
- metadata
- audit trails
- backups
- computer systems
FDA Recommendations
It also contains the draft FDA recommendations regarding computer system:
- validation scope
- access restrictions
- unique logins
- audit trail reviews
- electronic copies of paper records
- print outs of electronic records, and
- data falsification investigations
Download the FDA Draft Guidance here: Data Integrity and Compliance with cGMP
Do you need more help implementing these recommendations in your organization? Talk to our CSV experts about how you can update your practices for compliance.
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.
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