M-Files QMS is a comprehensive Quality Management System that helps organizations effectively manage their quality processes, ensure compliance with industry standards and regulations, and drive continuous improvement. It provides a centralized platform for managing quality documentation, automating workflows, and facilitating collaboration.

Document Control: M-Files QMS offers robust document control capabilities, including version control, document routing, and approval workflows. It ensures that the latest versions of quality documents, such as policies, procedures, and work instructions, are accessible to authorized personnel.
Change Management: The software facilitates change management processes by providing tools for documenting and tracking changes to quality documents. It ensures that changes are properly reviewed, approved, and implemented, maintaining compliance with regulatory requirements.
Audit Management: M-Files QMS helps organizations streamline their audit processes by providing features for planning, scheduling, and conducting audits. It enables the creation of audit checklists, tracks audit findings, and facilitates corrective and preventive actions (CAPA).
Non-Conformance Management: The system allows for the efficient recording, investigation, and resolution of non-conformances. It provides workflows to identify the root causes, implement corrective actions, and track their effectiveness.
Supplier Management: The software enables organizations to manage their supplier relationships, track supplier performance, and ensure compliance with supplier-related quality requirements.
Risk Management: M-Files QMS supports the identification, assessment, and mitigation of risks associated with quality processes. It helps organizations prioritize risks and implement appropriate controls.

Improved Compliance: M-Files QMS helps organizations meet regulatory requirements and industry standards by providing a structured approach to document control, change management, and audit processes.

Streamlined Workflows: The system automates and streamlines quality processes, reducing manual effort, eliminating paper-based workflows, and improving efficiency.

Enhanced Collaboration: M-Files QMS promotes collaboration among cross-functional teams by providing a centralized platform for accessing and sharing quality documents, facilitating real-time communication and feedback.

Increased Visibility: The software provides visibility into quality processes, allowing organizations to track and monitor the status of documents, audits, non-conformances, and corrective actions. This helps in identifying bottlenecks, ensuring accountability, and driving process improvement.

Scalability and Flexibility: M-Files QMS is scalable to accommodate the needs of organizations of different sizes. It can be configured to align with specific quality management requirements and easily adapts to changing business needs.

Regulatory Compliance: M-Files QMS helps organizations ensure compliance with industry regulations such as ISO 9001, FDA, GMP, and others by providing a framework for managing quality documentation, processes, and audits.

Quality Documentation Management: The system serves as a centralized repository for quality documents, allowing organizations to efficiently manage document versions, control access, and maintain a complete audit trail.

CAPA Management: M-Files QMS facilitates the management of corrective and preventive actions by automating workflows, tracking action plans, and monitoring their effectiveness in addressing quality issues.

Audit Management: The software streamlines the planning, execution, and tracking of audits, ensuring compliance with audit requirements and enabling timely corrective actions.

Risk Management: M-Files QMS supports organizations in identifying and mitigating risks associated with quality processes, helping prioritize efforts and implement risk controls.