Image 1 of 1
Image 1 of 1
Image 1 of 1
Image 1 of 1
This white paper demystifies 21 CFR Part 11 and Eudralex Annex 11, offering pharmaceutical professionals a clear, practical guide to achieving software compliance. It unveils the interconnected world of predicate rules, data integrity, and electronic signatures, weaving them into a cohesive narrative that underpins patient safety and regulatory confidence. From audit trails to GAMP 5 software categories, it illuminates common pitfalls, such as shared accounts and inadequate validations, that jeopardize compliance. Rich in expert insights, it challenges readers to rethink software validation as not merely a checkbox exercise, but a strategic pillar protecting public trust. A must-read for quality leaders, IT architects, and regulatory specialists dedicated to robust, inspection-ready digital systems that enable excellence in pharmaceutical manufacturing.
This white paper demystifies 21 CFR Part 11 and Eudralex Annex 11, offering pharmaceutical professionals a clear, practical guide to achieving software compliance. It unveils the interconnected world of predicate rules, data integrity, and electronic signatures, weaving them into a cohesive narrative that underpins patient safety and regulatory confidence. From audit trails to GAMP 5 software categories, it illuminates common pitfalls, such as shared accounts and inadequate validations, that jeopardize compliance. Rich in expert insights, it challenges readers to rethink software validation as not merely a checkbox exercise, but a strategic pillar protecting public trust. A must-read for quality leaders, IT architects, and regulatory specialists dedicated to robust, inspection-ready digital systems that enable excellence in pharmaceutical manufacturing.