Seeking UK pharma/CDMO deployer: AI audit-trail review for GxP manufacturing (BridgeAI Assurance & Compliance)

Arithmia (Glasgow) is leading a BridgeAI Deployment Catalyst bid in the Assurance & Compliance strand.

The problem: audit-trail review is usually sampled and slow. It sits in the batch-release path, and data integrity remains a leading cause of MHRA and FDA findings.

Arithmia Assure:

• Reads audit trails from CDS, LIMS, MES and EBR systems, read-only

• - Checks every entry against your SOPs, change controls, deviations, training records and rosters

• - Flags only unexplained events (shared logins, self-approval, reprocessing, out-of-hours changes), with the reason and the requirement

• - Leaves every decision with QA; confirmed issues go to your existing eQMS

• - Aligned to Annex 11, Part 11, GAMP 5 and ALCOA+, and runs in your own cloud

Phase 1: 3-5 months from spring 2027. We define the use case, assess readiness and demo Assure on anonymised data from one system. No live connection is needed, and your team's time is part-funded.

We're looking for: a UK medium or large pharma manufacturer, CDMO, biologics site or GMP testing lab (including NHS-licensed manufacturing units) willing to act as deployer (30-50% of project costs).

A free one-week Assure trial on one month of anonymised audit trails is available first. Application deadline: 8 December 2026.