In an age where paper-based records are being replaced by digital systems, 21 CFR Part 11 is the regulatory backbone that pharma manufacturers need to secure electronic records and signatures. It’s not just about meeting compliance requirements—it’s about ensuring data integrity across the board.
What Is 21 CFR Part 11?
The FDA’s 21 CFR Part 11 governs the use of electronic records and signatures, ensuring that they are trustworthy, reliable, and equivalent to paper records. It’s a comprehensive set of regulations that covers everything from data capture to storage, providing a framework for how manufacturers handle electronic data.
Key Requirements of 21 CFR Part 11
For compliance with 21 CFR Part 11, pharma manufacturers must ensure:
Secure and validated electronic records with appropriate timestamps
User authentication and access controls for electronic signatures
Audit trails to track all record creation, modification, and deletion
Procedures to ensure data accuracy, security, and retention for required periods
How ProcessXE® Supports 21 CFR Part 11 Compliance
By integrating the principles of 21 CFR Part 11 into your operations, ProcessXE® helps ensure:
Automated capture of validated electronic records with secure timestamps
Real-time audit trails for every action taken in the system
Full traceability of electronic signatures and their corresponding actions
Robust user authentication and access control mechanisms
In today’s digital age, ensuring compliance with 21 CFR Part 11 is not just a legal requirement—it’s vital to maintain the trust of regulators, auditors, and patients. ProcessXE® gives you the tools to stay compliant while ensuring your data integrity and security.
Why 21 CFR Part 11 Matters for Pharma Manufacturers
Pharmaceutical manufacturing is an industry with minimal tolerance for error. As regulations tighten and technology advances, manufacturers need a system that ensures compliance while enhancing operational efficiency. ProcessXE® enables you to achieve that balance.