Agentic AI for Biotech Operations
Multi-step AI agents that move work through your MES / LIMS / QMS instead of just answering questions about it. Wired into your operational systems via Anthropic MCP. Defined action envelope, named human-approval points, full audit trail. Built to survive a GxP inspection.
A4BEE Service
Agentic AI for Biotech Operations
Duration
10–14 weeks per agent (scope grows with integration count)
Who it's for
Pharma + biotech ops orgs with an integrated MES / LIMS / QMS estate and a named operational workflow they want to automate end-to-end
Format
Remote — kickoff workshop on-site week 1; weekly steering calls with QA + ops + IT leads; UAT + PQ on-site if required by local validation policy
Engagement size
1 Senior Engineer + 1 Validation Lead + 1 Solution Architect (full-time) + 0.25 Łukasz
Use cases we ship today
Deviation triage agent · change control router · supplier qualification agent · batch release pre-check · tech transfer dossier assistant
Integration model
Anthropic MCP servers wired to your MES (Werum / DeltaV / Opcenter), LIMS (LabWare / Empower), QMS (TrackWise / Veeva), ERP (SAP / Oracle)
Validation profile
Full V-model + GAMP 5 Category 5 (custom application) + 21 CFR Part 11 audit trails + EU Annex 11
What's different from a RAG assistant
Agents WRITE back into regulated systems. Read-only RAG is a separate, lighter-validation engagement (Service: GxP RAG).
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What you'll get, how we run it, the FAQ, and the book-now CTA are available to signed-in users. Free to register — and you get your assessment history in the same account.