SAP-Connected Manufacturing QC
SAP QM. 21 CFR 211. ICH Q10. Your lab data, speaking SAP.
Native SAP QM integration for manufacturing quality control labs. Bi-directional sync of inspection lots, usage decisions, and QC results — with full AILS audit trail, AI-assisted analysis, and GMP-compliant documentation that satisfies both your ERP team and your FDA inspector.
Built for SAP-Connected Manufacturing QC
Every capability is purpose-built for your compliance environment — not adapted from a generic platform.
Bi-Directional SAP Sync
Inspection lots pulled from SAP QM automatically. Usage decisions (A/R/RE) pushed back to SAP after AILS review. No manual data entry, no transcription errors.
Batch Release Integration
Manufacturing batch release decisions in AILS — with AI risk assessment, reviewer re-authentication, and full audit trail — sync back to SAP as usage decisions with GMP documentation.
QC Results Management
Inspection results captured in AILS with full traceability, then synchronized to SAP. Out-of-spec results trigger SAP quality notifications automatically.
GMP Electronic Signatures
21 CFR Part 11 controls on electronic signatures for every critical decision — with re-authentication, timestamping, and meaning — all synchronized to SAP records.
In-Process & Final Testing
In-process testing at manufacturing stages linked to batch records. Final product release testing with AI risk scoring and documented disposition.
Validation Documentation
IQ/OQ/PQ documentation for the SAP-AILS interface. RTM, OQ protocols for your team to execute, and a validation summary template — the vendor half of the binder your quality function completes for FDA review of the integrated system.
Purpose-built agents for SAP-Connected Manufacturing QC
Each agent operates on your live lab data, scoped to one specific job. Not a generic assistant.
Batch Release Risk Assessor
Evaluates batch records against ICH Q10 release criteria and SAP-sourced batch history. Returns scored risk assessment that drives SAP usage decision recommendation.
OOS AI Investigator
When SAP quality notifications trigger OOS events, AILS AI guides the 21 CFR 211.192 investigation — root cause, CAPA, and disposition documentation.
Validation Co-Pilot
Generates IQ/OQ/PQ protocols for the SAP QM interface validation. RTM maps AILS-SAP data flows to your regulatory requirements.
Enabled at tenant provisioning.
One platform. Your vertical. Ready today.
The SAP-Connected Manufacturing QC 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.