GxP Compliant AI
Enabling AI at scale in GxP-regulated processes in the Pharma, Biotech and Medtech industry
The successful transformation of GxP regulated processes, IT systems, and data is a complex challenge in the highly regulated life sciences sector. We support with smart solutions in the areas of GxP Quality Assurance, Regulatory Affairs, IT-Quality / CSV, as well as AI Compliance & Data Integrity.
After an initial wave of AI pilot projects, the Life Science industry is beginning to scale AI across the value chain – including GxP regulated areas. As AI adoption grows, it is crucial to implement frameworks that address the AI-specific risks and controls to maintain product quality, patient safety, and data integrity.
The IT Quality unit plays a key role in the acceptance and scale-up of AI usage in GxP regulated processes. It can do so by facilitating effective and efficient risk management, building trust with health authorities, and proactively engaging with AI platform providers to assess and support their qualification for the GxP environment.
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Successful scaling of AI in the GxP environment requires development teams to collaborate closely with AI compliance experts right from the start and throughout the development cycle. Regulators expect documented evidence that an AI development project is fully embedded in a risk and control framework covering the AI model and the training data. They also expect documented evidence that validation protocols were followed stringently.
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