In 2022, the US Food and Drug Administration (FDA) issued their draft guidance “Computer Software Assurance for Production and Quality System Software”
Digital display labels (DDLs) offer an alternative solution to eliminate manual relabeling in the clinical supply chain, optimizing label content updates through a simple, system-controlled approach while providing new, uncharted opportunities. With increased efficiency in making regulatory-compliant changes and enhanced flexibility in the clinical supply chain, DDL technology has the...
This article provides a brief introduction into the standards and regulations for medical devices. It compares the ISPE GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) and applicable ISPE GAMP Good Practice Guides against the relevant regulations and standards for the development of software for medical devices and demonstrates GAMP® 5 Second...
