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

Projects

Systems the ComplAI team has built: the problem they solved and how they were built. Only what we can prove.

Projects

CNP, for Gutis

The panel for Gutis's New Product Committee: projects, their plans and their dates live in the application and tracking is computed live. From the program review to the committee in nine days.

AI for queries onlyNew product portfolio

“Nine days after reviewing our processes, we were already presenting the panel to the committee.”

Greivin Mora, SAP Competence Center Manager at Gutis

Lingua, for Gutis

It translates GxP documents between Spanish and English without touching the format: AI translates, fixed rules watch figures and codes and a person resolves the doubts.

AI translates the documentsGxP document translation

“AI translates, we resolve the doubts and every document comes out with the same format as the original.”

Greivin Mora, SAP Competence Center Manager at Gutis

OqoVal, for Oqotech

A platform that uses AI to draft the complete CSV validation documentation, so that every project is done faster and costs less, with 21 CFR Part 11 signatures and an unalterable audit trail.

AI drafts the documentationCSV validation

“We validate faster and at a lower cost, without giving up anything on regulatory compliance.”

Mayte Garrote, CEO of Oqotech

Let's talk about your process

Tell us which process you want to solve and we'll tell you how we would approach it.