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It is now well known by the Life Sciences community that the new version of EU GMP Annex 1, which was issued on 22nd August 2022, will come into force on 25 August 2023 (with the exception of chapter 8.123 "Product transfer/loading/unloadin...

An Enterprise Quality Management System is a software solution that ensures compliance with regulatory guidelines. It supports the cross-distribution of data across the value chain via a communications platform that allows collaboration between vario...

Hearing complaints is dreaded by any organization, but it can be a deeper issue for the regulated sector. The truth is that addressing complaints is an opportunity for improvement if they are managed positively.