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
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Navigating the Pitfalls of MSAT for Successful Technology Transfer: In the biopharmaceutical sector, MS&T responsibilities extend to both upstream and downstream processes. This includes optimizing cell culture conditions, managing bioreactor performance, and ensuring effective purification
Unleashing the Power of AI in BioPharma : Artificial Intelligence (AI) has the potential to transform industries, enhance efficiency, and drive innovation across various sectors, from healthcare to finance and beyond. AI is revolutionizing how we approach problems and create solutions.
FDA regulation of Artificial Intelligence (AI) and Machine Learning (ML) follows a risk-based framework focused on safety and effectiveness throughout the product lifecycle. As of mid-2025, the FDA has authorized over 1,250 AI-enabled medical devices, with nearly 80% used in radiology .
The pharmaceutical industry stands at a crossroads where regulatory expectations continue to evolve, patient safety remains paramount, and competitive pressures demand operational excellence. In this complex landscape, organizations …