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m files qms

Ensure your quality processes and policies are being followed with M-Files QMS – the practical solution to compliant document management.


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 & BenefitsM filesUses

Improve your quality procedures with a comprehensive set of features that assist with:
• Quality standards such as ISO 9001
• CE marking or labelling
• 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
• Food production
• Transportation, including aviation and automotive
• Mining and more

Quality assurance, audits and deviations

Manage audits and inspections, and efficiently record and process deviations and corrective actions.

Document control

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.

Other features

• Repetitive task automation
• Inventory, lists, and registries
• Signature management
• 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

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