regenold GmbH
regenold GmbH: “regenold GmbH is an end-to-end integrated development partner for pharmaceuticals, medical devices, and drug-device combination products. Since 1994, regenold has guided more than 2,000 innovators through over 10,000 successful product submissions across 90+ countries.”
Do we need documentation if AI is "just drafting"?
“Yes. If an AI tool influences clinical, CMC, or regulatory decisions, you must document how it works, how it was validated, and what controls are in place, regardless of whether the output is "final" or "just a draft." The question that should be asked is not "does it make the decision?" but "does it influence the decision?".”
在公司资料中查看What should we be ready to show in an inspection?
“Based on the current regulatory frameworks, AI systems used in regulated processes are expected to have documented risk classification, validation evidence, and change control. Responsibility for approving and monitoring the model should be clearly assigned, with defined human oversight.”
在公司资料中查看How do we qualify a vendor AI tool?
“Start with due diligence on the vendor's training data, model evidence, and update practices. Review documentation and contracts. Classify the tool's risk. Make sure you can demonstrate control over updates, performance monitoring, and bias. The depth of qualification depends on the GxP impact of the tool's output.”
在公司资料中查看