Software Simplifies Compliance With 21 CFR Part 11 And EudraLex Good Manufacturing Practice Volume 4 Annex 11

The FDA’s 21 CFR Part 11 and the EU’s EudraLex Volume 4 Annex 11 outline standards for electronic records and signatures in GMP-regulated industries. These regulations ensure that electronic documentation is as reliable and secure as paper-based systems, facilitating compliance and operational efficiency. Key requirements include maintaining data authenticity, linking electronic signatures to individual users, and implementing validated systems to ensure accuracy, reliability, and data integrity.

Both regulations emphasize access control, requiring user-specific permissions to safeguard records and prevent unauthorized actions. Immutable audit trails, electronic backups, and enhanced searchability improve operational reliability and streamline audits. The systems must ensure secure storage and accessibility throughout data retention periods, with regular backups validated for accuracy and restoration capability.

Annex 11 highlights additional responsibilities, such as conducting accuracy checks for critical manually entered data and ensuring software validation and change control documentation. Similarly, 21 CFR Part 11 mandates that software be validated to prevent altered or invalid records, with users responsible for defining retention policies and ensuring proper system usage.

Modern software like Bio4C ProcessPad™ and Bio4C ACE™ supports compliance by providing built-in tools for data management, audit trails, and electronic signatures. These systems facilitate regulatory alignment while enabling streamlined operations and improved collaboration. However, users remain responsible for process validation, system qualification, and compliance with operational standards, ensuring their systems meet regulatory requirements for their intended use.