M-Files QMS

M-Files QMS makes it easy to ensure that quality processes and policies are actually being followed!

Meet Quality Certification and Regulatory Compliance Requirements

M-Files QMS is an easy and practical solution that helps manufacturing organizations and related businesses fulfill the documentation requirements associated with:

ISO & FDA Compliance
  • 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

Pharma & Manufacturing QMS

M-Files QMS is ideally suited for businesses in regulated industries, such as:

  • Pharmaceutical and Life Sciences, including Medical Devices, Biotechnology and Clinical Research Organizations
  • Petrochemicals and other process-related manufacturing
  • Food Production
  • Transportation, including aviation, automotive, etc.
  • Mining

Improve Quality Systems and Meet Quality Certification Requirements

M-Files QMS includes a comprehensive set of modules to cover quality procedures such as:

  • Document Control: Organize and manage all quality related documents such as SOPs with complete version history, security, workflow, publishing

  • Quality Assurance, Audits and Deviations: Manage audits and inspections, and efficiently process and document deviations and corrective actions.

  • Repetitive Task Automation: Automate and document recurring tasks and processes with reminder.

  • Personnel: Assign role-based access rights and track experience and skills for employees and subcontractors

  • Training: 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 system inventories with full version history

Simplify and Automate with Powerful M-Files QMS Tools

  • Signing, eSignatures, and Handwritten Signatures:
    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 certificate

  • Calendar view with integrated scheduling and follow-up reminders

  • Validation toolkit to validate your implementation, remain in compliance

For more information on how to use M-Files in Pharmaceutical and Life Sciences, please read the brochures:

For more information on improving your Quality Systems with M-Files QMS, please contact your local M-Files partner, or contact M-Files directly at
sales@m-files.com.