Guide: what the draft Annex 22 requires of AI in GMPRead the guide

Tell us what's getting stuck

The first conversation is technical, and you have it with the person who will design the system. If it turns out we're not the right option, we'll tell you on that same call.

Send us your inquiry

How the work is done today and which part of it lives in spreadsheets, emails or paper.

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We assess a process with you

The first step in every project.

Where time is lost

We review how the work is done today and which part of it lives in spreadsheets, emails or paper.

How much control it calls for

What impact it has on the patient, the product and data integrity, and what evidence would have to be produced as a result.

Whether AI adds value

Whether a model can prepare part of the work, what a person would always decide and what would have to be validated.

Whether it's worth it

By the end you'll know whether the project pays off for you. If it doesn't, we'll tell you, even if that means we don't work together.