Integrated Quality Management
Across Multi-Standard Compliance
CNWAYLab QMS covers ISO 9001/17025, GMP, ISO 13485 multi-standard requirements, integrating document management, training management, change control, deviation/CAPA, audit management, and risk management — achieving a fully digital quality management closed loop with complete traceability. Supports electronic signatures and audit trails, meeting 21 CFR Part 11 compliance requirements.
Six Quality Management Capabilities
Covering all elements of a quality management system, from document control to risk management, building a digital compliance closed loop.
Document Management
SOP version control, controlled distribution and expired document retrieval with electronic signatures and approval workflows. Full document lifecycle traceability with automatic periodic review and revision reminders, ensuring only current effective versions are in use.
Training Management
Online learning platform, assessment question bank, and training matrix that automatically links personnel qualifications to position permissions. New hire onboarding and SOP revisions automatically trigger corresponding training tasks — no operational access without passing assessments.
Change Control
Full-chain digitization from change request, impact assessment, and multi-level approval through to implementation tracking. Automatically links affected documents, equipment, and processes; upon change completion triggers related SOP revisions and personnel re-training for a management closed loop.
Deviation & CAPA
Complete closed loop for OOS/OOT deviation registration, root cause analysis, CAPA development and effectiveness verification. Supports fishbone diagram and 5-Why analysis tools with automatic CAPA due-date reminders and post-closure effectiveness review triggers.
Internal & External Audits
Integrated audit planning, configurable checklists, non-conformance registration, and corrective action tracking. Supports ISO 9001/17025, GMP, ISO 13485 multi-system audit templates with audit findings directly initiating CAPA and real-time closure rate dashboard monitoring.
Risk Management
Built-in FMEA, HACCP, ICH Q9 and other risk assessment tools with customizable risk matrices. Quality risks are automatically linked to change, deviation, and CAPA processes, forming a complete risk management chain from identification to control.
Ready to Digitize Your Quality Management System?
Book a 30-minute demo to see how QMS helps your organization achieve multi-standard compliance digitally.
We offer a 14-day free trial with no commitment required.