Implementation of 21 CFR Part 11 and EU GMP Annex 11

This white paper outlines the implementation of 21 CFR Part 11 and EU GMP Annex 11 in the epMotion software, focusing on regulatory compliance in the pharmaceutical, healthcare, and medical device industries. It details the legal requirements of both regulations and compares them with the technical specifications of the Enhanced Feature Set GxP for the epBlue software, which is used alongside the epMotion automated liquid handling device. The paper describes how the epBlue GxP software assists users in meeting compliance standards through features such as system validation, electronic record generation, and audit trails. It emphasizes the importance of maintaining data integrity and security, including user access controls and the ability to generate accurate electronic records suitable for inspection. The document also discusses the responsibilities of user organizations in validating their applications and ensuring compliance with relevant quality management systems, including ISO 13485 and ISO 9001. Overall, the white paper serves as a comprehensive guide for implementing these regulatory requirements effectively.