M-Files QMS makes it easy for businesses to improve their quality management systems and meet certification requirements with document and process management capabilities designed for organizations with strict quality and compliance needs.
Top Features & Benefits
Improve your quality procedures with a comprehensive set of features that assist with:
- Quality standards such as ISO 9001
- CE marking or labeling
- Compliance with FDA 21 CFR Part 11 and EU GMP Annex 11
- Audits associated with all of the above
Is your business in a highly regulated industry? M-Files QMS is also ideal for:
- Pharmaceutical and life sciences, including medical devices, biotechnology and clinical research organizations
- Petrochemicals and other process-related manufacturing
- Food production
- Transportation, including aviation and automotive
- Mining and more
Repetitive task automation
Automate and document recurring tasks and processes with comprehensive workflow capabilities and reminder notifications.
Quality assurance, audits and deviations
Manage audits and inspections, and efficiently record and process deviations and corrective actions.
Organize and manage all quality-related documents, such as Standard Operating Procedures (SOPs) and Corrective and Preventative Actions (CAPAs), with complete version history, security, workflow and publishing.
Assign role-based access rights and track experience and skills for employees and subcontractors.
Manage course lists and materials, and record, track and report on training.
Inventory, lists, and registries
Build and manage company-specific inventories and lists, including software and hardware inventories, with full version history.
When documents must be approved or authorized, M-Files QMS supports three signing options: built-in digital signing, external digital signing services and handwritten signatures.
- PDF conversion, watermarking and content protection with certificates
- Calendar view with integrated scheduling and follow-up reminders
- Validation toolkit to validate your implementation and remain in compliance