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
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 .
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 artificial intelligence revolution isn’t coming, it’s here. While only 13% of companies globally are ready to leverage AI and AI-powered technologies to their full potential, the organizations that prepare…