Ensure your quality processes, compliance and certifications. 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. 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.
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.
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