Annex 11 : Electronic signature and Batch release for Medicinal products
The Annex 11 regulation provides guidance on how to implement an electronic signature system that meets the requirements of the
21 CFR part 11 : Electronic records and Electronic signatures
The Code of Federal Regulations (CFR) is the official codification of the general and permanent rules published in the Federal
The Key Differences Between CFR Part 11 and Annex 11
The compliance landscape for electronic records and signatures is constantly evolving. Two key sets of regulations that have shaped this landscape are
