Ideas, reactions, and news for quality and validation professionals in life sciences. From the team at VLMcare.
Why object-based validation turns validation data into connected, reusable objects and makes the requirements traceability matrix a real-time asset.
The current guidance from FDA and EMA on AI in life sciences manufacturing for validation teams. Bottom line: the practice of risk-based validation hasn't changed with AI, and why the barrier to AI use is a myth.
VLMcare completed a full CSV, CQV, and lab instrument validation rollout — from kickoff to production go-live — in just six weeks, powered by its object-based platform.
How GAMP 5, PIC/S PI 041-1, MHRA, and FDA guidance build on ALCOA+ principles to define data integrity in GxP environments for validation programs.