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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...

Top 11 FAQs about GMP Guidelines for Quality Management Systems The GMP guidelines are mandatory in most countries for pharmaceuticals, medical devices, and food industries. Companies that fail to comply with these guidelines can face severe regulato...

Change is essential for growth, no matter which sector your company or organization excels in. However, change can also be a trying period in any company unless you and your team are well prepared for it. The best way to prepare yourself and your tea...

Today, the Quality conversation is no longer about making the digital leap from an outdated paper-based Quality Management System (a traditional QMS) to managing your Quality processes with electronic Quality Management software (an eQMS).  That tran...

Implementing a Quality Management System is key to ensuring consistency in all your processes and, ultimately, guaranteeing your product quality and safety.  A well-established QMS will allow you to meet both customer and organizational requirements,...

CSV and CSA both play the same role in the digitally matured life sciences companies. Yet, these approaches have some key differences. In this article, we will review the differences between CSV and CSA. Until very recently, CSA was seen as a futuris...

Healthcare faces complex challenges in a world that is becoming more digital day-to-day. It has become clear that healthcare companies will need to embrace open systems that allow for the sophisticated analysis of multiple data streams and the develo...