Quality and Compliance Management Solutions

M-Files QMS is an easy-to-use quality management solution for SOP management, quality document control, audits, CAPAs, risk management, training and employee qualification.
Globally, Organizations use M-Files QMS to support compliance with ISO 9001, ISO/IEC 27001, ISO 13485, ISO 27002, FDA 21 CFR Part 11, EU GMP Annex 11, and many others.

Benefits of M-Files Quality and Compliance Solutions

Document Control
  • Organize and manage all quality documents, such as Standard Operating Procedures (SOPs), policies and work instructions with complete major/minor version history, automatic permissions, built-in annotation and redlining, eSigning, configurable workflows, several publishing options and unprecedented ease of use.
  • Manage a single key document in several languages simultaneously, with dedicated workflows for both document creation and translation. Great for global policies, user guides, patient material etc.
  • Provide controlled printing with printout copy stamping and tracking of controlled printouts.
  • Ensure that quality documents are actually learned by the correct personnel.
  • Training and Learning
  • Elevate any content, such as quality documents and courses, into mandatory learning material for selected staff. Define the learners via any HR property, role or group membership.
  • Automate: System automatically calculates and constantly updates a personal training to-do list for every person, including a full induction training list for the new employee.
  • Extend training requirements to personnel without login access to M-Files QMS system, such as factory workers, temporary staff and subcontractors.
  • Build up-to-date reports on training performance, or pending and overdue training requirements.
  • Quality assurance, audits and deviations
  • Manage audits and inspections, and efficiently record and process deviations, audit findings and risks.
  • Easily store all audit records, files and email correspondence.
  • Ensure corrective actions are actually completed in due time - and not forgotten in memos, spreadsheets or emails.
  • Personnel
  • Assign role-based access rights and track experience and skills for employees and subcontractors.
  • Extend learning and qualification requirements to any personnel, including external persons with no login access to the M-Files QMS system.
  • Periodic task automation
  • Automate recurring tasks and processes, and capture auditable evidence of all task completion with comprehensive task handling capabilities.
  • Inventory, lists and registries
  • Build and manage company-specific inventories and lists, including software and hardware inventories, with full version history.
  • Signature management
  • M-Files QMS provides a rich set of approval and signing options from single-click workflow approval all the way to Part 11 compliant eSigning or legally binding digital signatures. Please learn more at this white paper M-Files Approval and Signing Solutions.
  • Other features
  • PDF overlay processing, watermarking and content protection with certificates.
  • Calendar view with integrated scheduling and follow-up reminders.
  • Ensure sensitive documents exclusively remain in the M-Files QMS system with the Print and Download Prevention feature.