Software Development for GxP Regulated Industries

Software development for GxP-regulated companies involves additional requirements, including specific guidelines from EU Annex 11, and FDA CFR Part 11. These requirements cover aspects such as electronic signatures, audit trails, data integrity, and more. Due to the stringent regulations governing GxP-regulated companies, software and system suppliers must adhere to established rules and procedures for developing, releasing, implementing, and maintaining software. When validation or pre-validation is needed, this book explains how to implement agile validation by embedding the validation process within the development cycle, rather than using the traditional V-Model validation based on the waterfall approach. In this book, you will find valuable information to help you develop and make software attractive from a compliance point of view for GxP-regulated industries, including pharmaceuticals, laboratories, clinical trials, and the broader life sciences sector. You will also find numerous tips on how a software development vendor can prepare for a supplier audit conducted by a GxP-regulated company.