21 CFR Part 11
21 CFR Part11 is a regulation established by the FDA that governs the use of electronic records and electronic signatures in regulated operations of the Life Sciences.
EU GMP Annex 11
EU GMP Annex 11 is a guidance document that supplements the European Union’s GMP rules and provides guidelines for computerized systems used in GMP-regulated activities in the Life Sciences.
It covers various aspects such as electronic forms, documents, signatures, and increased scrutiny of site inspections.
21 CFR Part 11 vs. EU GMP Annex 11
FDA 21 CFR Part 11 and EU GMP Annex 11 address similar concerns and aim to achieve the same goals, namely data integrity, comprehensive audit trails, limited system access, trained users, and more.
However, there are notable differences between these regulations.
Framework
The FDA 21 CFR Part 11 regulatory framework outlines the criteria governing electronic records and signatures.
It is a comprehensive set of requirements for ensuring electronic documentation’s integrity, authenticity, and reliability within FDA-regulated industries.
On the other hand, the EU Annex 11 is a guideline that provides general principles for computerized systems used in GMP activities.
Overarching Structure
21 CFR Part 11 is divided into three subparts:
Subpart A – General Provisions discusses the scope of the regulation, the implementation process, and includes definitions of some terms used in the regulation.
Subpart B – Electronic Records describes the control requirements of users of closed and open systems. It also describes the requirements for signature manifestations and requirements linked to electronic records and signatures.
Subpart C – Electronic Signatures focuses on general requirements for electronic signatures, electronic signature components and controls, and controls for identification codes/passwords.
Annex 11 consists of four sections:
The first section provides general guidance on topics such as risk management, personnel, suppliers, and service providers.
The second section provides guidelines for the project phase and operational phase, including best practices for validation.
The third segment covers best practices for the operational phase and maintenance of computerized systems: accuracy checks, data storage, printouts, audit trails, change and configuration management, periodic evaluation, security, incident management, electronic signature, batch release, business continuity, and archiving.
The fourth section covers key definitions in the glossary.
Audit Trails
In 21 CFR Part 11, audit trails are required for all electronic records, encompassing a broader range of data.
On the other hand, in EU Annex 11, audit trails are specific for GMP-relevant data.
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