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What is M-Files QMS?

by | Oct 1, 2021 | QMS

M-Files QMS is a document management technology, which is used by SimplerQMS to build a ready-to-use eQMS Solution for the Life Science Industry. 

M-Files was founded in 1987 and over the course of 30 years, they have been developing, tweaking, and testing their platform on real-world data from thousands of customers. Now, M-Files serves more than 5.000 customers worldwide and allows for automation of critical business processes while handling your information in a secured and controlled manner.

In this article, you will learn:

M-Files QMS

SimplerQMS chose to use the M-Files QMS because of its reliable and proven technology so that we can provide a solution of the highest standards to our life science customers.

Now, let’s talk a little bit about the structure of SimplerQMS and how M-Files is our ‘engine’ that runs behind the scenes. The picture below demonstrates how do we relate to our partners and what is the structure of the software.

simplerqms system structure

Let’s take it step by step. The first thing that is important to mention in this illustration is the Microsoft Azure component. Microsoft Azure allows you to access your data from any location securely and without the hassles and costs related to running your own servers. All data is encrypted, monitored 24/7 and the backups are performed every 15 minutes.

M-Files serves as our core technology, stores data in the Microsoft Azure Cloud, and supports the features of SimplerQMS. SimplerQMS then uses the capabilities and usability of M-Files to construct a trustworthy system that complies with regulatory standards and regulations such as FDA 21 CFR Part 11, GxP and GMP, ISO13485:2016, MDR, etc.

simplerqms certifications and compliance graphic

SimplerQMS has been constructed specifically for life-science organizations. Its workflows, processes, layout, features, and possibilities are all set to ensure high levels of efficiency. Yet another point to mention here is that SimplerQMS is continuously validated. This allows us to implement the software faster and with lower costs. Furthermore, our customers don’t need to spend any additional time on Computer Software Validation, in order to comply with the GxP, ISO, and FDA requirements.

Advantages of an M-Files QMS

Aside from its reliability and history, what are some other features of M-Files quality management that you could benefit from?

Full Integration

M-Files document management system is fully integrated with Microsoft Office, Azure, Microsoft Dynamics, Salesforce, and many more applications. This allows the users to edit and save documents without the need to download them, apply changes, and then re-upload every time a change is made. Instead, they can easily modify the documents in a familiar Microsoft Office environment and save them with 1 click. On the other hand, the possibility to integrate the system with Jira, Salesforce, and so on lets SimplerQMS users create even more efficient and customized functions within the M-Files QMS.

Audit-Ready Documentation

The M-Files QMS allows for the storage of all records and approvals with versioning, audit trails, and electronic signatures in one cloud storage location. This translates to a quality management system where you can search for documents with a couple of clicks and always find documents in the correct locations.

SimplerQMS as an M-Files QMS

As it was mentioned before, SimplerQMS, built on top of the M-Files Document Management System, was designed to ease QA/RA management for life-science companies. We wanted to find a way to resolve common pain points that we had using QMS and eQMS tools at various companies. The software allows you to ensure compliance across your team with specific notifications and forms. You can automate workflows, calibration activities, change control processes, and more. Furthermore, unlike other vendors, we provide all our modules, implementation, and validation in one package for a single price. Some of the modules that typically bring the fastest improvements include:

Document Control in M-Files SimplerQMS

The Document control component in M-Files SimplerQMS ensures that the right employees have access to the correct documents. This module allows you to set access rights for specific people based on their roles, departments, assigned projects, and more. Automated workflows will then automatically notify them about newly assigned tasks and built-in part 11 compliant e-signatures will allow any internal or external person to easily sign documents.    

Additionally, seamless integration with Microsoft office applications grants you the possibility to enforce standardized and approved forms which can be managed in a familiar setting. These documents are then automatically named, numbered, and versioned.

  • Easy setting of access rights and automatic notifications
  • FDA 21 CFR Part 11 compliant QMS software with eSignatures and audit trails
  • Seamless integration with Microsoft Office
  • Automatic naming, numbering and versioning of documents

Training Management in M-Files SimplerQMS

This part of the system lets you assign training activities to employees based on their functional roles and avoid expired certifications. Thanks to the automatic notifications, trainees won’t miss out on new instructions, documents, videos, or potential requirements for training certificate renewals. Finally, M-Files SimplerQMS automatically gathers data in compliance with GDPR and allows you to generate dashboards to get a better overview of your organization’s training status.

  • GDPR compliant permission settings to efficiently handle sensitive data
  • Better overview of the training status with automatically generated dashboards
  • No more expired employee certifications

CAPA Management in M-Files SimplerQMS

M-Files SimplerQMS CAPA management allows you to automate data collection, routing, follow-ups, notifications, approvals, and escalation of overdue activities. You can identify patterns in your data via built-in dashboards and easily see impacted components by each complaint, deviation, nonconformance, or other issue. Tracing deviations and non-conformances back to their root causes suddenly becomes easier and faster. Furthermore, thanks to the real-time trends feature you can identify, assess, and correct areas of concern before they become reality.

  • Automatic data collection, routing, follow ups and more
  • Easier investigation of root causes that lead to non-conformances and deviations
  • Real time issue identification

Change Management in M-Files SimplerQMS

With this module, you can easily link objects, such as design control change records, nonconformances, customer complaints, CAPAs, and audits. Thanks to full traceability you can see exactly when, what, by whom, and why changes were made. With this information, you can quickly identify the impact of changes and spend less time preparing for audits.

  • Have a clear overview about your documentation with object linking
  • Seamless Full Traceability
  • Immediately identify all components affected by change

Supplier Management in M-Files SimplerQMS

The supplier management part of the M-Files SimplerQMS module schedules reoccurring supplier reviews and maintains a list of approved suppliers. You can search for a supplier name, a sourced component, or a document and quickly find the information you are looking for. By using supplier dashboards, you get an overview of all suppliers and the records that are related to them. The continuous monitoring will then allow you to quickly show the necessary information to auditors via our audit-ready dashboards.

  • Search for a supplier name and easily view every document and records that is linked to the specific supplier
  • Easy preparation for audits with audit-ready dashboards

If you would be interested to find out how the current customers feel about our software, you can take a look at the case study of cortex technologies. Thanks to SimplerQMS they were able to reduce their time spent on change management by more than 50% and achieve better traceability than ever before. The video below is a compilation that was created by talking with Cortex Technologies about their experiences with the system.

eQMS Business Case Template

Illustration of Non Conformance Report Template