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ERP
Pharma & Life Sciences
August 17, 2026
Launching a Medical Device in the US? Start With These Four Steps
Being ISO 13485 certified doesn't automatically make you FDA-inspection-ready. It gets you close, but the two frameworks are not a one-to-one match, and the...
Thomas Van Dorpe
ERP
Pharma & Life Sciences
August 17, 2026
Why your CE mark won't get you onto the US Market
For many European medical device companies, the US represents the next growth market. The surprise comes when they discover thata CE mark, established quality...
Thomas Van Dorpe
ERP
Pharma & Life Sciences
August 17, 2026
AI in medical devices: What the FDA's predetermined change control plan actually covers
Your medical device's AI algorithm will not stay the same after it reaches the market. It will be retrained, refined, and improved, and every one of those...
Thomas Van Dorpe
ERP
Pharma & Life Sciences
August 11, 2026
Surfing the AI Wave: How Pharma can Harness Agents
The Fastest Tech Wave Ever Technology adoption has never moved this fast. Mobile phones took 16 years to reach 100 million users. The Internet needed seven....
Thomas Van Dorpe
ERP
Pharma & Life Sciences
May 04, 2026
What Pharma Can (and Cannot) Do with AI Under Annex 22
The business wants AI agents. The use cases look compelling. The technology is evolving faster than most organisations can comfortably track. Then someone from...
Thomas Van Dorpe
ERP
Pharma & Life Sciences
May 04, 2026
Who Owns AI in Pharma? Why Governance Must Be Cross‑Functional
Most pharma AI initiatives do not fail because the technology does not work. They fail because no one can clearly answer a much more basic question: Who owns...
Thomas Van Dorpe
ERP
Pharma & Life Sciences
May 04, 2026
EU GMP Annex 11 & Annex 22: The New Compliance Reality for AI in Pharma
Pharma is in the middle of its biggest regulatory shift in more than 30 years. For the first time, regulators are explicitly addressing AI, with dedicated...
Thomas Van Dorpe
ERP
Pharma & Life Sciences
March 19, 2026
Why AI belongs on the Pharma C-level strategic agenda
Artificial intelligence is no longer a future technology for pharma; it is already part of the infrastructure that supports scientific progress, operational...
Thomas Nielsen
ERP
Pharma & Life Sciences
December 15, 2025
Use Case: Post-Market Surveillance and Safety Powered by AI
The work doesn’t stop when a drug reaches the market. In fact, one of the most critical phases begins: monitoring patient safety. Pharmacovigilance is a...
Thomas Van Dorpe
ERP
Pharma & Life Sciences
December 15, 2025
Use Case: Clinical Trials Reimagined with AI Agents
Bringing a new drug to market is one of the most demanding challenges in the pharmaceutical industry. Clinical trials are essential, but they are long, costly,...
Thomas Van Dorpe