Quality & Compliance Management Intelligence
Accelerate quality event resolution and regulatory compliance through intelligent workflow automation that extends SAP QM capabilities. Enable structured NCMR processes, CAPA orchestration, and audit trail management for FDA, ISO, and GMP-regulated manufacturing environments.
Compliance-first architecture: Side-by-side sidecar designed for regulated industries with strict audit and validation requirements. Each implementation aligns to your quality management system, regulatory framework, and SAP QM configuration.
Upgrade-Safe Compliance
Keep SAP QM stable for audits. Extend quality workflows through APIs and events—no brittle customizations.
Faster Issue Resolution
Structured workflows for NCMRs, root-cause analysis, and CAPA tracking reduce resolution time and improve compliance.
Audit-Ready Evidence
Automated evidence packets, immutable audit trails, and compliance reporting for FDA, ISO, or GMP audits.
Example Capabilities We Can Build
Your quality sidecar will include only the modules that address your specific compliance gaps and workflow bottlenecks. Common starting points:
NCMR logging & tracking
Simple forms for non-conformance reports with batch/lot traceability—auto-linked to SAP quality notifications or independent tracking.
Root-cause analysis assistant
Guided templates (5 Whys, Fishbone) with optional AI suggestions for common failure modes—keep analysis structured and auditable.
CAPA workflow automation
Corrective and preventive action tracking with approvals, due dates, and escalation rules—evidence trail for auditors.
Batch/lot notifications
Automated alerts when quality issues arise for specific batches—route to production, QA, and supply chain stakeholders.
Supplier quality management
Track vendor defects, PPM rates, and corrective action requests—integrate with vendor scorecards and procurement workflows.
Compliance reporting & evidence packs
Pre-built reports for ISO audits, FDA inspections, or internal reviews—export evidence packets with full lineage and approvals.
How It Integrates with SAP QM
The quality sidecar sits beside SAP, handling user workflows and compliance documentation while SAP QM remains the system of record for quality data. We typically start with simple read-only connections and add write-back only as needed.
Integration Patterns (Start Simple)
- • Read-only first: Pull quality notifications, inspection lots, batches, and material master data via SAP OData/REST APIs.
- • Event-driven (optional): Subscribe to quality notification changes or batch status updates for real-time alerts.
- • Write-back (as needed): Post approved CAPA actions or supplier quality claims back to SAP QM through controlled APIs.
- • Compliance exports: Generate evidence packets and reports without touching SAP—keep audit trails separate and immutable.
Data Model (Keep It Simple)
- • Start with basic NCMR fields (defect type, batch, root cause)—expand schema as your quality processes mature.
- • Map SAP quality notification IDs and inspection lot numbers to sidecar records for traceability.
- • Add audit trails and evidence storage only where compliance requires it—no over-engineering.
Notifications & Workflow
- • Automated alerts when quality issues arise for specific batches or materials—route to QA, production, and suppliers.
- • Escalation rules for overdue CAPAs or pending approvals—ensure compliance deadlines are met.
- • Email/SMS/Slack integrations for notifications—keep stakeholders informed without SAP logins.
Security & Compliance
We implement security and compliance controls appropriate to your regulatory environment—starting with basic authentication and expanding to FDA 21 CFR Part 11 or ISO requirements as needed.
Audit Trails & Evidence
Immutable audit logs for all NCMR changes, CAPA approvals, and root-cause edits. Export evidence packets with full lineage for FDA, ISO, or internal audits.
Access Control (As Needed)
Role-based access for QA, production, and management users. Add electronic signatures and approval workflows only if 21 CFR Part 11 or equivalent compliance requires it.
Delivery Approach
We start small, ship quickly, and expand based on what you actually need—not what a requirements doc promised.
Scoping & access
Confirm which quality processes need automation, which SAP QM data is available, and define MVP scope—typically 1-2 core workflows (e.g., NCMR logging + CAPA tracking).
Build & ship MVP
Deliver a working quality portal with your priority features—usually read-only integration with SAP QM to start, expanding to write-back as needed.
Production deployment
Deploy with basic monitoring and compliance controls—add complexity (electronic signatures, 21 CFR Part 11 compliance) only if regulations demand it.
Expand (optional)
Add modules like supplier quality management, advanced analytics, or AI-assisted root-cause analysis based on actual usage and feedback.
Related Content
Vendor 360: SAP Vendor Portal
Supplier onboarding and performance tracking—complements supplier quality workflows.
Manufacturing Solutions
Our approach to regulated manufacturing environments requiring FDA, ISO, and GMP compliance.
All Integration Examples
Explore other SAP sidecar applications for field service, master data, and more.
Ready to discuss quality management automation?
We'll scope a custom quality sidecar that fits your SAP QM landscape and compliance requirements—starting with a simple MVP that solves your immediate NCMR, CAPA, or audit challenges.