Quality management is the act of overseeing adherance to processes, complaince and certification of tasks needed to maintain a desired level of excellence.

Organizations require quality management software 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.

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

M-Files QMS provides a truly unique, real life problem solving training solution that tracks not just all the training records you have, but also the ones you should have.

• 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 Quality Management Software 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. Read this white paper to learn more – M-Files Approval and Signing Solutions.

Watch video: Learn how to simplify and streamline document approvals with digital signatures.

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.

• Pharmaceutical and life sciences, including medical devices, biotechnology, health tech, diagnostics and CROs
• Petrochemicals and any process-related manufacturing
• Food and beverage
• Transportation, aviation, automotive and off-shore
• Energy, mining and more