21 CFR part 11 Compliance Guide
What is 21 CFR Part 11 Compliance?
21 CFR Part 11 compliance is an FDA regulation that establishes the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. It requires strict controls for data integrity, audit trails, and system validation in pharmaceutical and biotech environments.
How AuditSafe Ensures 21 CFR Part 11, ALCOA and EU Annex 11 Compliance
This document presents the technical features of our AuditSafe software and how it complies with respect to FDA 21 CFR part 11 subpart B – Electronic Records and EU Annex 11 and how these individual regulations can be satisfied to help your organization comply with them.
Each regulation is translated in easy to understand terms and explained to present a more easy-to-read document.
We outline how our AuditSafe software and the customer’s organization share the responsibilities for compliance and where the boundaries for each lie.
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.
The regulations we provide are true to the publishing date.
AuditSafe is intended to facilitate FDA 21 CFR Part 11, EU Annex 11, ALCOA, GAMP5 and more general GMP/GxP compliance. It is the user’s responsibility to ensure that the software is appropriately validated within the context of the user’s particular environment (a service which TotalLab can provide in the form of IQOQ during installation), and to ensure that the compliance elements that sit outside of the software are implemented appropriately.
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