Products

M-Files Quality Management

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 You Will Get

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.

Features

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.