An AI copilot — trained on your controlled content.
Built by life science experts to simplify ai / llm assist.
“It’s the first AI we’ve trusted on GxP content — because it cites, refuses obsolete docs and never decides on its own.”
Improved traceability & automation
Replace manual coordination with structured, configurable workflows — with a full audit trail on every action.
Confident compliance
Designed to support FDA 21 CFR Part 11, EU GMP Annex 11 and ISO 13485 — inspection-ready by default.
Data-driven oversight
Monitor activity, backlogs and compliance KPIs in real time so leadership has the visibility it needs.
Faster implementation
Go live in weeks — not quarters — with structured rollout, training and 24/7 support.
From day one — every step controlled.
Semantic search across SOPs
- Ask in natural language, get the right paragraph
- Cite the SOP, version and effective date
- Respect role-based access at query time
- Never return obsolete or draft content
Complaint auto-triage
- Classify incoming complaints
- Suggest reportability based on past cases
- Draft acknowledgement and investigation prompts
- Hand off to a human with a clean summary
Validation drafting
- Draft URS, test scripts and summary reports
- Reuse content from prior validated systems
- Flag gaps against GAMP 5 expectations
- Keep a human in every approval step
Audit-prep summaries
- Summarise a topic across documents and events
- Surface inconsistencies before an inspector does
- Prepare interview briefs by role
- Cite every claim back to source
Everything LLM ships with.
Grounded retrieval
Answers cite controlled, current sources — no hallucinated content.
Role-aware access
Queries respect document and record permissions.
Private deployment
Your data stays in your tenant. No training on customer data.
Audit trail of prompts
Every prompt, response and citation logged.
Human-in-the-loop
AI drafts, humans review and sign — always.
Configurable guardrails
Restrict scope by module, role or document class.
Designed to support the standards you’re audited against.
See LLM on your own data.
Bring a real scenario from your operations — we’ll show you exactly how AI / LLM Assist handles it.