https://qlogix.ai/blog QLogix blog: regulatory updates on AI in GxP, FDA and EU guidance explained, and how life sciences quality teams adopt and validate AI. en-us Tue, 13 Oct 2026 04:27:48 GMT https://qlogix.ai/blog/fda-ai-credibility-framework https://qlogix.ai/blog/fda-ai-credibility-framework Mon, 12 Oct 2026 12:00:00 GMT AI in quality FDA's draft guidance asks sponsors to show that an AI model is credible for a specific context of use. The effort scales with model risk: how much the model's output drives the decision, and how serious a wrong decision would be. https://qlogix.ai/blog/ai-in-drug-manufacturing-fda https://qlogix.ai/blog/ai-in-drug-manufacturing-fda Mon, 12 Oct 2026 12:00:00 GMT Manufacturing science FDA has no final guidance written only for AI in drug manufacturing. It has a 2023 discussion paper naming five open areas and a 2025 draft framework that covers manufacturing models. Together they show what a process model has to prove. https://qlogix.ai/blog/ai-enabled-medical-devices-fda https://qlogix.ai/blog/ai-enabled-medical-devices-fda Mon, 12 Oct 2026 12:00:00 GMT Medical devices FDA's public list counted 1,614 AI-enabled medical devices through June 2026, about three in four of them in radiology. Two documents shape how they are built and changed: the final guidance on predetermined change control plans and the draft guidance on lifecycle management. https://qlogix.ai/blog/robotics-aseptic-manufacturing-annex-1 https://qlogix.ai/blog/robotics-aseptic-manufacturing-annex-1 Mon, 12 Oct 2026 12:00:00 GMT Manufacturing science The revised EU GMP Annex 1 names robotic systems, with isolators and RABS, as technologies to consider for protecting sterile products. Taking the operator out of the critical zone removes the largest contamination source and moves the quality work to design, software and data. https://qlogix.ai/blog/eu-gmp-annex-22-ai-draft https://qlogix.ai/blog/eu-gmp-annex-22-ai-draft Mon, 12 Oct 2026 12:00:00 GMT Regulatory updates Draft Annex 22 is the first GMP annex written for AI. It allows static, deterministic models in critical GMP applications, keeps generative AI out of them, and asks for a defined intended use, independent test data and ongoing monitoring. https://qlogix.ai/blog/computer-software-assurance-final-guidance https://qlogix.ai/blog/computer-software-assurance-final-guidance Mon, 12 Oct 2026 12:00:00 GMT Validation FDA's final guidance on computer software assurance replaces test-everything validation with effort matched to risk. Features that could compromise safety get scripted testing; the rest can be covered by unscripted testing and supplier evidence.