Embrace eBMR : 3 Key elements to Meeting Global Pharma Regulations – EU Annex 11; 21 CFR 11; Data Integrity – The core purpose of The Digital Imperative relating to eBMR application is to document every step of the manufacturing process
You’ve heard the buzz, the big promises, the dystopian warnings. But what’s the real story? Let’s peel back the curtain and talk about the good, the bad, and the truly, unbelievably ugly parts of AI, with a little help from some of the smartest people
The journey to the GMP lab of the future is not without its obstacles. These challenges require careful planning, significant investment, and a willingness to embrace change at every level of the organization.
Automating digital data management in biopharmaceutical manufacturing is a process of using digital technologies such as cloud, artificial intelligence, data lakes, and wearables to collect, store, analyze, and share data across the entire development lifecycle.
Biopharmaceuticals shall demonstrate at any time their compliance with Data Integrity (DI) requirements. We all know that data Integrity is not a new topic rather, it is an old concept made essential in today’s digital age.