FDA CSA Guidance Published

The FDA has published their draft guidance for Industry, "Computer Software Assurance for Production and Quality System Software". This guidance provides recommendations on CSA for computers and automated data processing systems used as part of medical device production or the quality system. Copies of the guidance are available on the FDA website.

GAMP CoP UK Forum

Great to meet with other businesses at the forum on 11 Oct 2022, which focussed on the recent publication of ISPE GAMP 5 Second Edition. The presentations were very informative and prompted useful interactive discussions with the attendees. Many thanks to ITS for sponsoring the event at the Centre for Professional and Executive Development in Darlington.

GAMP 5 Second Edition

ISPE GAMP 5 Second Edition has been published! This document maintains the principles and framework of the First Edition, but has been revised to address the increased importance of service providers, evolving approaches to software development, use of software tools & automation, and the use of Critical Thinking by Subject Matter Experts.