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AI Governance for Life Sciences.

Helping Organisations Become AI Inspection Ready

Know where AI is used. Govern the decisions. Demonstrate the evidence.

 AI is entering regulated work faster than many organisations can account for it. We help life sciences organisations understand how AI is being used, build the capability to manage it responsibly, and establish governance they can demonstrate when questioned. 

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TRUSTED BY

AI may already be influencing decisions across your site

Some use is approved and understood. Some happens informally. AI may also arrive through tools and suppliers that are already part of your operation.

For site leaders, Quality and operational teams, the question is practical: where is AI being used, what decisions does it affect, who is accountable, and what evidence supports the controls in place?

An approved tools list cannot answer all of that. People, processes and records must work together.

OUR PROGRAMME

Trust by Design™

A practical route from uncertainty to evidence 

Trust by Design™ is our approach to AI governance in regulated organisations. It connects the way people use AI with the decisions, controls and records needed to manage it.

Three clearly scoped areas of support. We begin where your organisation needs us.

Assess your position

Governance Diagnostic

 Understand where AI is being used, the decisions it affects and the controls already in place. We work with your leadership team to identify the gaps that matter most. 

 

 

Build capability

 AI Governance Enablement  

 Equip people to use, approve and oversee AI responsibly. We shape learning around their roles and the decisions they make at work. 

 

Evidence and assurance

Put governance into practice 

 Put the agreed approach into practice and maintain a clear record of how AI use is managed. Build a position your team can explain and support with evidence. 

 

Who we work with

One site. Connected responsibilities.

AI affects more than one function. Site leadership needs visibility and direction. Quality and Compliance need appropriate controls and evidence. Operational teams need to know where AI is useful and how to use it within agreed boundaries.

We bring those perspectives into the same conversation.

 

Pharma, medtech & life sciences

 For organisations where AI may affect regulated processes, records or decisions, and where accountability has to be clear. 

The suppliers who serve life sciences

 For engineering, validation and technical service providers whose people use AI while working with client processes, information or systems. 

 

Why The Institute of Applied AI?

Built for the realities of regulated work

We bring experience in pharmaceutical operations, capability development and AI governance. We understand that a framework has little value unless the people responsible can use it, maintain it and explain the decisions it supports.

Our work is designed to help your organisation develop that capability. We provide a defined starting point, practical support and a route your team can carry forward.

 

Could your team explain how AI is being used today?

 The first step is a conversation about what is already happening, what controls exist and where you may need a clearer view. A Governance Diagnostic can turn that conversation into agreed priorities. 

 

AI in Motion

 Practical analysis of AI governance, regulation and adoption in life sciences. 

 

Pharma & MedTech