21 CFR part 11 compliance guide

21 CFR part 11 compliance guide

This document presents the technical features of Version Control in regards to 21 CFR part 11 subpart B – Electronic Records and how these individual regulations can be satisfied and help your organisation comply with the Food and Drug Administration’s (FDA) 21 CFR part 11 regulations.

Each regulation is translated and explained for a more easy-to-read document.

We outline how our Version Control software and the customer organisation share responsibilities for achieving compliance.

Before reading the document please note that the explanations we provide represent our interpretations of the 21 CFR part 11 regulations. We do not represent any government agency and nothing in this guide should be taken as fact.

The regulations we provide are true to the publishing date.

Version Control is intended to address GLP/GMP requirements in compliance with 21 CFR part 11. It is the user’s responsibility to ensure that the software is appropriately validated within the context of the user’s particular environment, and to ensure that the other part 11 compliance elements are implemented appropriately.

Download the guide: Version Control Compliance Guide