GxP Compliance Electronic Records and Signatures Guide

This guide provides an overview of GxP compliance, focusing on electronic records and signatures. It outlines the essential quality guidelines and regulations that ensure products and projects are safe and meet their intended use throughout various stages, including manufacturing and distribution. The document compares FDA 21 CFR Part 11 and EU Annex 11, highlighting their objectives and validation requirements. It details the importance of data integrity and security in maintaining electronic records and signatures, emphasizing the need for validated systems. Additionally, the guide presents best practices for managing electronic records, including access control, password policies, and audit trails. It introduces the ALCOA+ principles, which serve as benchmarks for data integrity in GxP compliance. The document concludes with a summary of necessary steps for compliance, such as documented procedures, trained personnel, and the implementation of an appropriate electronic quality system.