Ideas, reactions, and news for quality and validation professionals in life sciences. From the team at VLMcare.
Digitizing a document-based process keeps its inefficiencies. Here's what validation looks like when requirements, evidence, traceability, workflow, and signatures become connected records.
Why AI requires ongoing monitoring, governed retraining, and periodic reviews that verify the monitoring process.
How VLMcare's object-based validation platform maps to the ten ALCOA++ data integrity principles, from attributable e-signatures to live, always-current traceability.
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.