The Connected Quality Platform for Life Sciences
One unified quality layer across 8 core modules with built-in ALCOA+ cryptographic data integrity.
Document Management
Automated GxP document lifecycle with 21 CFR Part 11 electronic signatures, controlled copy watermarks, and cryptographic source file hashing.
FDA 21 CFR Part 11 • Annex 11 • ISO 13485Quality Events & CAPA
Structured intake for 7 event types (Incidents, Deviations, Complaints, OOS/OOT) with guided 5-Whys RCA, auto-CAPA triggers, and effectiveness checks.
FDA QMSR (21 CFR 820) / ISO 13485 §8.5 • 21 CFR 211.192Change Control
Govern process, equipment, and IT changes with mandatory multi-disciplinary impact assessments and risk-based CCB approval routing.
FDA QMSR (21 CFR 820) / ISO 13485 §7.3 • ICH Q10 • Annex 15Training Management
Snapshot-locked quiz integrity, automated SOP training triggers upon document release, and expirable qualification matrices.
FDA QMSR / ISO 13485 §6.2 • 21 CFR 211.25Risk Management
Central dynamic FMEA engine with severity dominance, statistical drift alerts, ALARP justifications, and direct cross-module traceability.
ISO 14971:2019 • ICH Q9 (R1) • ISO 13485 §7.1Audit Management
End-to-end planning, execution, and reporting for internal, supplier, and regulatory audits with the Unified Assignment Framework.
ISO 19011:2018 • FDA QMSR / ISO 13485 §8.2.4Supplier Quality
Approved Supplier Lists, automated certificate renewal alerts, quality hold suspensions, and zero-license external SCAR vendor portals.
FDA QMSR / ISO 13485 §7.4 • ICH Q7 & Q10 • 21 CFR 211.84Command Center & Analytics
Real-time compliance scorecard, single-inbox My Work queue, management review packages, and cryptographic audit hash chain verification.
ISO 13485 §5.6 • ICH Q10 • ALCOA+ IntegrityDynamic ISO 14971:2019 / ICH Q9(R1) Risk Intelligence Core
See how QMSdesk automatically detects risk drift and auto-triggers CAPA workflows upon critical threshold breach.
5x5 Risk Heatmap Coordinate
- ✓ISO 14971 Hazard classification mapped automatically.
- ✓Cross-module traceability to SOPs, Audits, and Supplier records.
⚠️ HIGH RISK: Flags 30-Day Cluster Alert and requires Quality Manager formal mitigation plan approval.
Streamlined Document Lifecycle & Signature Workflow
Experience how QMSdesk simplifies compliance: from authoring to effective release in 5 intuitive, foolproof steps.
Drafting & Authoring
- Author SOP or Work Instruction in rich-text editor or upload DOCX template
- Attach scope, department metadata, and target effective date
- Define initial change justification and impacted job curricula
SHA-256 cryptographic file hashing on upload verifies zero byte-level corruption.
Auto-assigns unique document ID (e.g. SOP-QC-042-v1.0) and locks concurrent draft editing.