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FDA’s Draft Guidance – A New Dawn for Software Validation

Home / News, Views & Updates / Monthly Archives: February 2026

FDA’s Draft Guidance – A New Dawn for Software Validation

By John Lafferty Article updated: March 2025 Read time: 3 minutes The draft guidance entitled Computer Software Assurance for Production and Quality System Software (dated 13th September 2022) represents a new dawn for software validation in a manufacturing environment. New: Un-...

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How to Make Software Validation Easier for Compliance with ISO 13485 and Pharma Regulations

By John Lafferty Software Validation just got a whole lot easier. The effort required comply with the software validation requirements of ISO 13485:2016 and 21 CFR Part 820 has been greatly reduced due to recent changes in regulations and guidance. Under the latest guidance, so...

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