M-Files QMS SimplerQMS

M-Files QMS (Quality Management System)

by | Feb 15, 2024 | QMS

M-Files is a document management software that empowers companies to manage all their information. M-Files helps manage data, regardless of type or location, within a single and intuitive interface.

The M-Files software can also be used as an Electronic Quality Management System (eQMS).

M-Files provides a flexible and configurable platform that enables companies to manage quality processes, documentation, and compliance requirements efficiently.

M-Files offers features that support the core components of an eQMS, such as document control, process automation, electronic signatures, audit trails, enterprise-level security, and more.

SimplerQMS has utilized M-Files as the foundational platform, configuring and building upon it to create a quality management system software tailored for the Life Sciences industry.

SimplerQMS has leveraged M-Files to develop integrated Life Science QMS modules, streamlining document control, change control, nonconformance, and deviation management, training management, and other quality management processes.

SimplerQMS integrates with Microsoft Entra ID (formerly Azure Active Directory) for user authentication and authorization, and it is hosted on Microsoft Azure cloud, ensuring secure and reliable access.

By combining M-Files and Microsoft technologies, SimplerQMS delivers a more streamlined and secure quality management experience, ensuring more efficient operations and helping ensure compliance.

SimplerQMS is a fully GAMP 5-validated quality management software designed specifically for Life Science companies. Learn how our software facilitates quality management and compliance efforts by booking a demo with our Quality Solution experts.

The following will be examined in greater detail.

What Is M-Files?

M-Files is a document management software that offers a cloud-based, metadata-driven platform. The platform enables companies to manage digital data and documents in a single repository.

The M-Files document management solution is designed to automate business processes and enforce information control.

The M-Files software solution is developed and provided by its namesake company, M-Files, a global company based in Finland.

M-Files is a global leader in information management solutions. M-Files employs over 500 individuals. It collaborates with over 300 partners worldwide. M-Files serves more than 5,000 customers. Its operations extend across more than 100 countries.

M-Files is used by small, medium, and large companies worldwide, including Bahlsen in Germany, Safran in France, Crowe in the United States, and others.

What Is M-Files QMS (Quality Management System)?

M-Files QMS (Quality Management System) is a software solution designed to manage and control quality documents, procedures, records, and processes.

M-Files QMS leverages the core capabilities of M-Files’ document management system, offering features tailored for quality management.

M-Files QMS is used for managing and controlling various aspects of quality and compliance within companies, including document management, change control, training, nonconformance management, audit management, and more. The system allows streamlined document management, process automation, and workflow control.

SimplerQMS provides an Electronic Quality Management System (eQMS) built on the M-Files quality management platform. SimplerQMS enhances the robust document management and workflow capabilities of the M-Files platform to offer a comprehensive and specialized eQMS solution for Life Science companies.

What Are the Benefits of M-Files QMS?

The benefits of M-Files QMS include, but are not limited to, the following.

  • Robust Document Management System
  • Full Integration With Microsoft Office   
  • Enterprise Level Security

Robust Document Management System

M-Files QMS serves as a centralized repository for all quality-related documents, fostering an environment of improved accessibility and control. The system helps eliminate information silos and outdated versions with a single source of truth for SOPs, procedures, forms, and records.

M-Files document management capabilities include customizable metadata for granular traceability and searchability of documents. M-files offers automated workflows to streamline review, approval, and signature processes.

Full Integration With Microsoft Office

M-Files QMS integrates seamlessly with the Microsoft Office suite, including Word, Excel, and PowerPoint.

The integration enables direct document editing within Microsoft applications. Changes in documents automatically synchronize with the central repository, eliminating burdensome download-edit-upload cycles.

Enterprise Level Security

M-Files QMS provides a robust security framework. Tamper-proof audit trails meticulously track every action, and electronic signatures further support accountability and regulatory compliance.

M-Files QMS complies and is certified to industry requirements such as ISO 9001:2015 (quality management system), ISO 27001:2022 (information security), ISO 27017:2015 (security techniques for cloud services), ISO 27018:2019 (protection of personally identifiable information), ISO 22301:2012 (business continuity management systems), SOC 2 and 3 (controls and systems security).

M-Files QMS supports achieving compliance with several requirements, including FDA 21 CFR part 11, Eudralex Vol 4 Annex 11, and HIPAA (Health Insurance Portability and Accountability Act), among others.

How SimplerQMS Uses M-Files QMS Tools?

SimplerQMS utilizes the tools provided by M-Files QMS to develop quality management modules designed for the Life Science QMS needs. SimplerQMS’s approach enables the creation of a comprehensive quality management system tailored to the unique requirements of companies in the Life Sciences industry.

Below are some of the key quality management processes where SimplerQMS utilizes M-Files QMS tools to suit the needs of Life Science companies.

  • Document Control
  • Change Control Management
  • Training Management
  • Nonconformance and Deviation Management
  • CAPA Management
  • Supplier Management

Document Control

SimplerQMS employs M-Files document management capabilities to control all quality-related documents. From SOPs and records to supplier information and training plans, everything resides in a single, secure location, readily available for authorized personnel.

SimplerQMS provides document control software that streamlines and automates quality-document activities, such as document review and approval process, document versioning, signing documents with electronic signatures, and more.

SimplerQMS system also integrates with Microsoft Office applications, such as Word, Excel, and PowerPoint. The integration allows documents within the system to be edited in the familiar Microsoft applications.

Change Control Management

SimplerQMS change control management module provides the foundation for effectively managing changes. Proposed changes are documented, reviewed, and approved following automated workflows.

SimplerQMS software streamlines change control management processes from initial change request creation to final approval and successful implementation.

All modifications to documents are automatically recorded within the system, complete with timestamps. These comprehensive records ensure accountability and facilitate compliance.

Training Management

SimplerQMS facilitates the management of employee training and the organization of training material. The system helps ensure employees complete training and stay up to date on essential knowledge by streamlining and automating essential tasks like training activity assignments, notifications, reminders, and training record creation.

The SimplerQMS training management capabilities enable training managers to create learning rules, assign relevant training materials, automate training assignments, track employee training progress, and more.

Nonconformance and Deviation Management

SimplerQMS software offers nonconformance management and deviation management modules.  

The nonconformance management module is designed to handle events where a product, process, or service does not meet specified requirements or standards.

Similarly, the deviation management module outlines how to control deviations in a structured and organized manner, including the event’s identification, reporting, investigation, resolution, and documentation.

All QMS modules are interlinked, allowing companies to escalate and relate nonconformance and deviations to CAPA with just a few clicks.

CAPA Management

SimplerQMS enables effective management of the CAPA lifecycle, from documenting root cause analysis to scheduling CAPA effectiveness checks.

The SimplerQMS CAPA management module simplifies the documentation and review process of quality events, facilitating continuous improvement efforts. The CAPA management module supports the development and implementation of actions aimed at preventing the recurrence of similar issues in the future.

The system also facilitates monitoring CAPA status with customizable views.

Supplier Management

SimplerQMS simplifies the management of supplier documents, contracts, qualification status, audits, and approved supplier lists (ASL).

Life Science companies use the SimplerQMS supplier management module to manage suppliers, from initial qualification and risk assessment to continuous monitoring and performance evaluation.

How SimplerQMS Uses M-Files and Microsoft Technologies?

SimplerQMS uses both M-Files and Microsoft technologies to create a comprehensive and secure Electronic Quality Management System (eQMS) tailored for the Life Sciences industry.

SimplerQMS uses the M-Files platform as its core foundation for document management and quality management processes. M-Files provides a versatile and robust document management system that supports metadata-driven document handling, version control, and process automation.

M-Files tools allow SimplerQMS to offer specialized modules for document control, change management, employee training, CAPA management, audit management, and supplier management, among others, facilitating effective quality management.

The modules include capabilities for handling controlled documents, managing change controls, planning audits, scheduling risk assessments, and more.

Broad quality management support helps Life Science companies ensure compliance with several Life Science requirements, such as ISO 9001:2015 and ICH Q10.

SimplerQMS integrates with Microsoft Entra ID (formerly Azure Active Directory) for secure user authentication and authorization.

Microsoft Entra ID provides single sign-on (SSO) capabilities and enforces strong authentication protocols like multi-factor authentication (MFA) logins, significantly reducing the risk of unauthorized access or compromised credentials.

SimplerQMS utilizes Microsoft Azure for cloud hosting, benefiting from Azure’s scalability, reliability, and security features. Azure hosting ensures that SimplerQMS offers its eQMS as a Software as a Service (SaaS), providing customers with easy access to their QMS without needing extensive IT infrastructure.

Microsoft Azure provides robust disaster recovery capabilities and supports compliance with data residency requirements, such as ISO 27001:2022, ISO 27017:2015, ISO 27018:2019, and ISO 27701:2019.

The SimplerQMS technology platform is built on established, proven technologies and complies with the industry requirements, empowering Life Science companies worldwide to confidently manage quality systems. SimplerQMS complies with Eudralex Volume 4 GMP Part I, Eudralex GMP Annex 11, FDA 21 CFR Part 11, 211, 212, and 820, and ISO 13485:2016.

Additionally, SimplerQMS is fully validated according to GAMP 5 and supports achieving compliance with Life Science-related requirements, such as ISO 13485:2016, ISO 15189:2022, 21 CFR Part 210, 211, 212 and 820, ICH Q10, and more.

Moreover, M-Files complies with ISO 27001:2022, ISO 27017:2015, ISO 27018:2014, ISO 22301:2012, ISO 9001:2015, SOC 2 and SOC 3, GDPR, SOX-404, and FIPS 140-2 Level 2.

And Microsoft Azure and Entra ID complies with ISO 27001:2022, ISO 27017:2015, ISO 27018:2014, ISO 22301:2012, ISO 9001:2015, SOC 1, SOC 2 and SOC 3, and GDPR.

SimplerQMS M-Files Microsoft Azure Technology

What Is the Role of Specialized M-Files Based QMS Software?

Specialized M-Files-based Quality Management System (QMS) software plays an essential role in addressing the unique needs of specific industries, providing tailored solutions for effective quality management.

Regular M-Files QMS serves a broad range of applications, providing a generic framework that may require additional customization to meet industry-specific compliance requirements.

In contrast, specialized M-Files-based QMS is purpose-built, incorporating industry-specific modules and workflows from the outset. Specialization ensures a more seamless integration into the existing processes of targeted industries, addressing their regulatory requirements more precisely.

SimplerQMS is a notable example, providing a specialized Life Science QMS software by utilizing M-Files features to build quality management process support designed for pharmaceutical, medical device, biotechnological, Contract Research Organizations (CRO), Contract Development and Manufacturing Organizations (CDMO), and other related industries.

What Is the Difference Between M-Files QMS and SimplerQMS?

The difference between M-Files QMS and SimplerQMS is the level of specialization, additional services, and industry-specific focus.

M-Files QMS provides a comprehensive set of tools for document management, workflow automation, and collaboration across various industries. M-files QMS solution is adaptable to different sectors and requires additional customization to meet industry-specific needs.

On the other hand, SimplerQMS utilizes the M-Files platform to offer a specialized QMS tailored explicitly for Life Science industries.

SimplerQMS goes beyond just utilizing the M-Files tools and offers added value through a comprehensive suite of services.

SimplerQMS solution includes a personalized implementation process, ensuring a seamless integration into the existing processes of Life Science companies. Comprehensive user training is provided to teach users the necessary knowledge and skills to navigate specialized software, ensuring effective utilization.

SimplerQMS also takes charge of system validation, relieving customers from the need to allocate additional resources. SimplerQMS system is fully validated according to GAMP 5 and kept permanently validated. Moreover, ongoing support is offered to address any queries or issues, providing QMS software that supports its effective use.

SimplerQMS uses M-Files QMS and Microsoft technologies to offer a tailored quality management solution for the Life Sciences industry. SimplerQMS provides all QMS modules, system implementation, user training, full validation, and ongoing customer support.

Experience how SimplerQMS can optimize your quality management processes and support your compliance. Book a demo with our expert Quality Solution Consultants to see SimplerQMS in action.

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