The AI quality agent.
Spec comparisons, deviations, and change control. The agent does the work — your team signs the decisions.
Quality work is scattered across documents, inboxes, and disconnected systems
COA reviews
Line-by-line COA checks against specs. Manual, slow, and one miss means a failed lot.
Deviation handling
Investigations live in email threads and Word docs. Root cause and CAPA steps slip, and aging deviations are a top inspection finding.
Change control
Change requests crawl through manual approval chains. Impact assessments and training get missed, and changes go live before they’re fully validated.
Ovada AI handles the operational work that slows regulated teams down
AI agents for regulated operations
From COA review to deviation handling to change control, Ovada AI handles end-to-end QA workflows with humans in the loop for decisions that matter.
Review COAs, handle deviations, and route issues — automatically
From COA parsing through deviation handling and change control, the QA agent handles the legwork. Humans approve the decisions that matter.
From COA to disposition, automatically.
The QA agent handles the parsing, comparison, and routing. Your team approves the decisions that matter.
COA Intake
Documents arrive from suppliers via email, portal, or upload. Ovada parses every field automatically.
Field Extraction
Test names, results, units, methods, and lot numbers — extracted with citations back to the source PDF.
Spec Comparison
Each result compared against your internal specs, USP monographs, or customer requirements.
Flag & Route
Mismatches, missing tests, and out-of-spec results are flagged and routed to the right reviewer with full context.
Human Disposition
Your reviewer approves, rejects, or escalates — with one click and a complete audit trail.
COA-2026-0512.pdf
Microcrystalline Cellulose, NF
Meridian Pharma Solutions · Lot MCC-2026-0512 · Spec Comparison
Spec vs COA
| Parameter | Spec | COA | Status |
|---|---|---|---|
| Identification (IR) | Conforms | Conforms | Pass |
| Assay | 97.0–102.0% | 99.2% | Pass |
| Loss on Drying | ≤ 7.0% | 4.8% | Pass |
| Residual Solvents (USP <467>) | Per USP <467> | Method ref missing | Flagged |
AI Summary
3 of 4 parameters pass. Residual solvents result is missing the USP <467> method reference. Routed to QA for review before lot disposition.
Ready to see Ovada AI in action?
Get StartedReviews in minutes. Nothing slips.
Live in days, not quarters
Regulation-anchored templates ship ready to run. Your SOPs apply as overlays — not a six-month implementation project.
Hours become minutes
Spec comparisons designed to complete in minutes, every parameter checked, with citations back to the source document.
Nothing falls through
Follow-ups, routing, and status-chasing run in the background. Deviations don't age in inboxes.
See how Ovada AI fits into your team's workflow.
Get StartedBuilt for the validated environment.
Every decision cites its source
Each agent decision traces to the regulation section or SOP clause that governs it. No uncited output.
Humans sign what matters
Part 11 electronic-signature ceremonies on dispositions, approvals, and workflow authorization. The agent never signs for you.
An audit trail that can't be edited
Append-only records, version-stamped decisions. Nothing overwritten, everything replayable.
Inspection-ready by default
When an auditor asks, the answer already exists. Retrieve what's already true — instantly.
GAMP 5 risk-based validation scoping. EU Annex 11 alongside Part 11.
See security & validationThe AI Validation Toolkit
GAMP 5 and Part 11 guidance for quality leaders evaluating AI — validation scoping, vendor audit questions, and audit-trail requirements. Coming soon.
We'll send it when it ships. No other email.
Frequently asked questions
Always inspection-ready.
Every decision cited, signed, and instantly retrievable. See how Ovada fits your quality system.