Meet Requirements For Daily Quality Processes And Regulatory Compliance With 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 and benefits
– Improve your quality procedures with a comprehensive set of features that assist with:
– 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

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
– Petrochemicals and other process-related manufacturing
– Food production
– Transportation, including aviation and automotive
– Mining and more

Compliance and Risk Management

  • Gated access ensures information security with control over who can access documents at different process stages

  • Version tracking ensures documentation is accurate and the most recent at all times

  • Role-⁠based permissions change information access automatically when people leave or change roles

  • Artificial Intelligence enables greater visibility and control over existing documents through automatic metadata tagging

  • Master record tagging keeps documents aligned and auditable by client, engagement, or project

  • Dark data scanning brings risks under control with discovery and tagging across all storage systems and repositories

  • Audit trail views of document version histories help speed up the process of demonstrating compliance

  • Data retention and destruction policies can be automatically implemented across storage platforms, users, and teams.

More on quality management platform

Want to know more about how M-Files manages quality and compliance? Here are some concrete examples.

GDPR compliance – With our quality management platform, you can find documents that contain personal information (PII), sort them out and ensure they are managed according to GDPR rules. 
 
LIBOR transition – By the end of 2021, many financial services companies will have to remove any reference to LIBOR in active financial products and contracts. We have a 5-steps solution for this. 
 
Safety and risk – Storing or transporting hazardous material exposes companies to further scrutiny and regulations. One of our customers has improved their safety and risk management procedures with M-Files.

 

Mitani Case Study

Read how Mitani has improved quality processes with M-Files

Our customer provides custom-made food products for food manufacturers. With M-Files quality management platform they have decreased Corrective Action Reporting processes from 60 to 14 days, and they have been green-lighted for one audit per year instead of two for certification from industry bodies. “M-Files has made people’s daily tasks much easier and less tedious, which means people are excited about their work; and it shows in their performance.”

Find out more about Navigating Through Security & Compliance Obstacles 

Contact us to learn more about how M-Files can work for you: