AI governance for life sciences
Faster research, safety and quality work, with records your quality system can rely on.
Peruze is a UK independent AI governance service for pharmaceutical, biotech, medical technology and contract research organisations. Life sciences companies are using AI across research, trials, safety, manufacturing and medical affairs. We help you capture the value while protecting patient safety, data integrity and your standing with regulators.
Where AI is arriving
AI is arriving across the product lifecycle.
Research and development
Assistants summarising literature and analysing data, with unpublished research kept in approved tools.
Clinical and safety
Trial documents drafted, and adverse event reports read and prepared for your safety teams to assess.
Manufacturing and quality
Support for deviation investigations, batch records and quality documents, with people deciding every GxP outcome.
Medical and commercial
Medical information, regulatory writing and field materials drafted with AI, and copilots in Microsoft 365.
What others expect of you
Inspectors, partners and patients will want to see how AI is controlled.
- Every GxP decision made and recorded by an accountable person
- Data integrity kept wherever AI touches regulated records
- AI used by your contract research organisations and suppliers held to your standards in the contract
- Unpublished research and patient data used only in tools you have approved
For pharmaceutical, biotech and medical technology companies, and the contract research organisations that work with them, we work with your quality and regulatory teams to map your AI controls to the guidance you already follow, such as GxP data integrity and computerised systems guidance, and to what the MHRA, EMA and FDA expect. EU GMP guidance on AI (Annex 22) is still in draft, so we follow the direction it sets and track it as it changes. We don’t validate systems or make GxP decisions: your quality and regulatory teams stay accountable for every GxP decision, and your quality system decides how our records fit into it.
The questions to start with
Three questions for your leadership and quality teams.
AI helps your people work
Which AI tools are scientists and staff using, and could unpublished research or patient data be reaching them?
AI does the work
Who owns each agent in safety, quality and clinical operations, and could you evidence its work to an inspector?
AI becomes your business
Where healthcare professionals or patients deal with your AI directly, could you explain every answer it gives?
Know what AI is running in your company, and keep it governed.
Start with a 45-minute walkthrough on the framework and where your AI sits today, and agree the right first step with us.