M-Files QMS - FTS

M-Files QMS

Get ready for audits and certifications!

Short Overview

M-Files Quality Management is an easy-to-use and practice-oriented solution for quality management.

The M-Files Quality Management solution helps manufacturing and other companies from high-regulated industries meet specific documentation requirements related to:

  • international quality standards such as ISO 9001;
  • CE marking;
  • FDA 21 CFR Part 11 and EU GMP Annex 11 standards;
  • audits for compliance with the above standards.

Benefits for Business

Improved quality management system

You can be sure to fully comply with certification requirements, standards, and audit procedures.

Simplified and automated business processes

The solution allows you to reduce errors and misinterpreting as processes become automated and standardized across the entire enterprise.

Shared information

Employees use a single database of quality documents and actions, notes and trainings.

Control over important documents

Compliance with review and approval procedures. The electronic archive ensures the use of only up-to-date versions of documents.

Timely task completions

Employees responsible for quality management carry out tasks on schedule: revision of standard operating procedures, staff training, maintenance of assets, deadlines of corrective and preventive actions, etc.


Document management

The system helps employees to organize and manage all quality-related documents (standard operating procedures, specifications, regulations, etc.) secured, keeping all versions and document changes, with mandatory approval processes and controlled publication.

Quality control management

Quality managers can launch processes and fix notes on quality audits and inspections. In the system, where all objects connected and history of actions available, you can process documents on deviations, nonconformances and corrective actions more efficiently.

Task automation

Supervisors and managers can use templates for repetitive tasks and processes; they get notifications on status of jobs done, and responsible employees receive automatic reminders on the deadline.

Personnel management

Access rights become assigned to users based on roles. All proofs of experience and qualifications of employees and contractors are kept in the storage.

Training management

You can plan and schedule regular and advanced trainings, register participants, mark their progress and outcomes.

Directories and registries

Responsible employees can create and manage directories, including on fixed assets, inventories, software, etc.

Converting documents for archiving

For archiving, you can convert documents to PDF, watermark, and secure content with a certificate.

Digital, electronic and handwritten signature

When documents need to be approved, M-Files QMS supports three signature options: embedded digital signature, external digital signature services, and handwritten signature.

Working calendar

Working calendar helps schedule tasks, plan trainings, audits, quality actions. It sends automatic reminders for due dates.

Toolkit for compliance with international standards

Who is this for?

Pharmaceuticals and clinical research

Manufacturing of medical equipment


Chemical and petrochemical industry

Beverage and food production

Transport, including aviation, automobile, etc.

Organizations in any industry certified to international standards such as ISO 9001

Get a full control over quality, compliance and audits!

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Frequently Asked Questions

    What is the average implementation time for a medium-sized company?

    The average period for the implementation project spans within 3 months, with standard functionalities for document and process automation.

    How does M-Files differ from other ECM systems?

    • The key principle of M-Files, it is important what the user is looking for (content in context), and not where it is stored (location). This principle becomes the basis for the next generation of ECM systems and content services platforms.
    • The architecture of the M-Files system is based on metadata or properties, characteristics. Metadata is information that describes documents, files, or other objects in the system to associate information repositories with other applications. It allows users to quickly find the information they need and view content in context with other key information and business processes.
    • You can browse data in all connected systems and repositories with the same user interface — something that other ECM solutions don’t offer.

    Name 3 reasons, why we should choose M-Files as ECM system.

    • Usability and fast learning thanks to familiar M-Files interface for Windows users. Employees do not want to have yet another system to work with. They want a tool that will be clear and easy-to-use from the first day of work.
    • Quick process of implementation and integration with existing systems. M-Files has ready-to-go solutions for integration with popular systems and services.
    • M-Files organizes and manages information based on ‘what’ it is, rather than ‘where’ it’s stored on the company network. Regardless of whether that information resides in the M-Files platform, or across other systems and repositories, information can be accessed and managed through a single view, without requiring costly and time-consuming data migration.