Navigating the complex waters of Life Sciences regulations? Two standards tower above the rest – 21 CFR Part 11 and EU GMP Annex 11. Here’s why they’re non-negotiable:
Foundation of quality and integrity: Both safeguards ensure the highest standards of Quality, product integrity, and safety in the Life Sciences.
Compliance isn’t just about checking legal boxes; it’s about patient welfare, data precision, and cementing your organization’s gold-standard reputation.
21 CFR Part 11 vs. EU GMP Annex 11
21 CFR Part 11: Part 11 is a regulation issued by the U.S. Food and Drug Administration (FDA).
EU GMP Annex 11: Annex 11 is part of the European Union’s Good Manufacturing Practice (GMP) guidelines.
21 CFR Part 11: Renowned for its meticulous framework. It’s the regulatory magnifying glass, highlighting specifics and demanding precision, surpassing the level of general guidance inherent in EU GMP Annex 11.
21 CFR Part 11: Part 11 specifically deals with electronic records and electronic signatures used in FDA-regulated industries.
EU GMP Annex 11: Annex 11 focuses on computerized systems used in GMP-regulated activities.
EU GMP Annex 11: While both standards play pivotal roles in ensuring data integrity and product Quality, Annex 11 offers a broader guidance, painting the bigger picture for organizations and helping them set the right course.