Pharmaceutical / GMP
21 CFR 211. ICH Q10. Batch release. OOS. All in one governed platform.
Every pharmaceutical QC workflow — from OOS investigation to batch release decision — managed under 21 CFR 211 and ICH Q10 governance. AI-assisted root cause analysis, automated risk assessment, and tamper-evident audit trails built in from day one.
Built for Pharmaceutical / GMP
Every capability is purpose-built for your compliance environment — not adapted from a generic platform.
OOS Investigation Workflow
Structured 21 CFR 211.192 OOS investigations — Phase I lab investigation, Phase II manufacturing investigation, and disposition decision — all documented, linked, and audit-trailed.
Batch Release Management
Full batch record review workflow with AI risk assessment. Hold / Release / Conditional output with documented rationale and reviewer re-authentication.
Method Validation
Track method validation protocols and results — linearity, accuracy, precision, specificity, LOD/LOQ — linked to COA issuance gates.
Stability Studies
Schedule and track ICH Q1A stability protocols. Automated out-of-trend alerts and trend analysis across time points and conditions.
Change Control
Formal change control workflow with impact assessment, approvals, implementation verification, and effectiveness monitoring.
21 CFR Part 11 Controls
Designed to meet 21 CFR Part 11: electronic signatures with re-authentication, a complete audit trail, record integrity (SHA-256), and the vendor documentation your validation cites — enforced in code, not left to procedure.
Reserve & Retain Samples
Track reserve samples against their retention requirement, with a record of who pulled one, when, and why — the evidence a 211.170 retained-sample inspection asks for.
Purpose-built agents for Pharmaceutical / GMP
Each agent operates on your live lab data, scoped to one specific job. Not a generic assistant.
OOS AI Investigator
Guides root cause analysis through 21 CFR 211.192 criteria. Suggests probable causes, supporting evidence requirements, and documentation standards for each phase.
Batch Release Risk Assessor
Evaluates batch records against ICH Q10 release criteria. Produces a scored risk assessment with Hold / Release / Conditional recommendation and documented rationale.
Validation Co-Pilot
Generates IQ/OQ/PQ step protocols from validation objectives. Automatically builds a Requirements Traceability Matrix (RTM) against your regulatory basis.
Enabled at tenant provisioning.
One platform. Your vertical. Ready today.
The Pharmaceutical workflows, compliance frameworks and AI agents ship today — built, tested, and covered by the platform test suite. Configuration, not architectural change, is what stands between you and go-live.