ABOUT VERHEIM

Built by people who have done the work.

Verheim brings experience from regulated manufacturing, validation and life-science consulting into a structured approach to AI.

We develop SAGA to help quality and validation teams turn project work into GxP deliverables. Defined workflows and customer-adapted templates give the work structure. Your specialists bring the expertise, assess the content and make the decisions.

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OUR BELIEF

We believe life-science companies should be able to adopt better technology while meeting their quality obligations.

THE PEOPLE BEHIND SAGA

Experience behind the method.

Our founders bring experience from both sides of the work: delivering projects inside regulated manufacturing and helping life-science companies manage computerised systems and compliance.

That experience shapes the questions we ask, the methods we build and the responsibilities we keep clear.

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Morten Hechmann Ekdahl

Morten’s experience spans validation projects, equipment integration and production cyber security in regulated manufacturing.

He has led development work using neural networks for production fault diagnosis and contributed to the rollout of GAMP 5, including training and the practical work of keeping documentation current after projects end.

His perspective brings the realities of production into the method: how equipment enters operation, how people take over the work and what they need to understand the decisions already made.

Connect with Morten on LinkedIn ↗

Klavs Esbjerg

Klavs founded Epista Life Science and built it into an international consultancy. A chemical engineer by training, he brings extensive experience in computerised system validation, 21 CFR Part 11 and GAMP 5 in manufacturing systems.

His perspective combines hands-on validation experience with the work of building teams and helping life-science companies adopt and manage technology.

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WHAT WE BELIEVE

Better technology. Professional judgment.

Make better technology practical.

That starts with the work itself. What does the team need to produce? Which procedures apply? What input matters? And what would a useful deliverable contain?

SAGA brings those questions into defined workflows, with methods and templates adapted to the agreed scope.

Put expertise where it matters.

Quality and validation work depends on people who understand the subject, recognise the trade-offs and take responsibility for their decisions.

Their expertise should shape the work throughout the process. SAGA supports preparation of the deliverables, giving specialists a structured basis to assess, question and develop.

Your people decide whether the content meets its purpose and approve it under your procedures.

AI GOVERNANCE AND RESPONSIBILITY

Clear answers before the first meeting.

Bringing AI into GxP work raises practical questions. Your quality, IT and security teams need to understand the setup, the boundaries and their responsibilities.

Here is where SAGA fits.

What happens to our existing systems?

SAGA prepares deliverables. It does not write to your document management system or quality management system, and it does not sign.

Formal review, approval and controlled records remain in your systems, under your procedures, with your designated people.

What information does SAGA need?

The starting point is the material needed for the task.

For Deviations and CAPA, your team supplies files such as event records, procedures, investigation results and relevant earlier cases. These workflows do not require a connection to your source systems.

Where a source connection is agreed for another workflow, its setup and permissions are scoped for the engagement.

Can we use any AI configuration?

We state the configurations each module is built and checked for.

A change to a different model requires re-checking against the workflow requirements. The supported setup and the implications of changing it are part of the conversation before implementation.

Who assesses and approves the work?

Your designated people assess the professional content, make the decisions and approve under your procedures.

We verify the defined functions and workflows. That verification is not computerised-system validation for your intended use; that responsibility remains within your quality system.

Have questions about data handling, security or your intended setup? Bring your IT, security and quality colleagues into the conversation so we can address the specific requirements together.

LET’S TALK

Bring the work. Bring the questions.

Tell us what your team needs to produce and what you need to understand before introducing AI. We can walk through a relevant SAGA workflow and discuss the setup, review and responsibilities around it.

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