BiopharmaIn build
An assistant that drafts and checks deviation and CAPA records.
We’re building an assistant that drafts and checks deviation and CAPA records against defined quality criteria, without writing to the quality system.
A biologics contract manufacturer
The situation
At a biologics manufacturing site, deviation investigation and CAPA documentation depended on the judgement of a small number of experienced investigators.
First-pass record quality varied, and investigation cycles ran long.
What we built
We’re building an assistant that drafts and checks deviation records across the three phases of a record – draft, investigation and CAPA – each against defined quality criteria.
A lean root-cause investigation method is part of the workflow from the start.
The investigator stays responsible for the record. The assistant helps produce a sound first pass and checks it against the criteria before review.
The decision that mattered
The assistant reads from the client’s quality management system and writes nothing back, a design the client’s quality function reviewed and approved as non-GxP for this intended use. The reason is that the investigator still writes and approves the record in the quality management system: the assistant’s draft is a working aid, not a GMP record. Hosting is in an EU data centre, early development ran in an isolated environment on synthetic data, and we assembled the evidence pack the client needs to show FDA auditors that the AI doesn’t edit source data.
Where it stands
The assistant is in build.
Along the way, the client’s own global technology function built a similar internal tool. The client chose to carry on with us, judging that the investigation method built into the workflow made our assistant stronger.