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 immutable 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 Enforcement
Electronic signatures with re-authentication, complete audit trail, record integrity (SHA-256), and validated system documentation — enforced at the architecture layer.
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.
Module key: pharma — enabled at tenant provisioning
One platform. Your vertical. Ready today.
AILS is already live in Pharmaceutical environments. Every workflow, every compliance framework, every AI agent — deployed and tested. Zero architectural changes needed to go live.