Quality Management Software for Life Sciences

Cloud-based quality management software that helps you manage quality and compliance with complex life science regulations and standards.

SimplerQMS Document Control Interface - Procedure List

Your eQMS software, designed specifically for the life sciences

SimplerQMS is an all-in-one solution. This means that our electronic quality management system (eQMS) will be delivered to you without any hidden fees for implementation, additional modules, user training, validation, or support. Everything is included in one price, it’s that simple.

Interlink all your quality processes

The quality management system software from SimplerQMS allows you to link objects to documents, easily integrate quality management processes, automate workflows or view all past changes to a document in a few clicks. In practice, this translates to quality management that is:


Fully traceable with the possibility to easily see how each change affects specific documents


Safely accessible from anywhere


Automatically reminding employees about their tasks, training, calibration activities, etc.


Preventing human error and saving your time

Integrated QMS Software
Life Science Regulatory Compliance

Save time and ensure compliance

The SimplerQMS quality management software and its features were developed with a focus on life science companies. This allowed some of our clients to cut their time spent on change management by more than 50%. When it comes to regulatory compliance, many quality management software systems offer compliance with ISO 13485. However, we went a step further and obtained an ISO 13485 certification for our QMS software system. Furthermore, the quality system software complies with GxP, GMP, GAMP 5, FDA 21 CFR Part 11, FDA 21 CFR Part 820, and EU MDR.

Start quickly and skip the validation related processes

We understand the limits on time and resources that organizations typically have when implementing new IT solutions. For that reason, we deliver our quality management software pre-validated. In practice, this means that you don’t have to spend your own time and resources to validate the QMS system software. In addition to that, we use a proven incremental implementation process which typically takes only 5-6 weeks.

Microsoft Office Documents
SimplerQMS Technology Platform

Utilize proven technology platforms

The technological core of the QMS software is formed by M-Files enterprise quality management system software. M-Files serves over 5000 customers worldwide and it is fully integrated with Microsoft Office, SalesForce, Jira, and other applications. On the other hand, Microsoft Azure Cloud acts as a remote storage space for your documents and allows you to securely access them from any location.

Work in familiar Microsoft Office interface

The integration to Microsoft Office will allow you to seamlessly edit and save documents within a familiar environment. There is no need to download and upload documents to edit them. Simply open the document and enjoy the efficiency.

Microsoft Office Interface
Life Science Module Setup

Pre-configured specifically for the Life Science industry

SimplerQMS quality management system software was developed to specifically deal with QMS issues for the life science industry. All workflows, features, possibilities, and designs of the QMS system software were crafted to allow you to easily navigate your quality management system and increase the efficiency of your work at the same time. To aid this, we provide pre-made templates and procedures with the software to make regulatory compliance a little simpler.

Looking for more modules?

Regardless of the stage of your organization, our quality management software modules cover all your needs.

Training Management Module Icon

Training Management

Automatic notifications for new trainable materials, expiring training certificates, and more.

CAPA Management Icon

CAPA Management

Automate your CAPA management process, analyze data with dashboards and find root causes more easily.

Document Management Module Icon

Document Control

Our QMS software is integrated with Microsoft Office so that you can save and see the effects of changes instantly.

Change Management Module Icon

Change Management

Recognize and manage all changes accordingly to ensure compliance and structure within your organization’s QMS.

What customers achieve with SimplerQMS

Utilize proven technology

SimplerQMS is built on Microsoft & M-Files Technology which serves over 5,000 customers worldwide.


Pass audit more easily

Access needed documentation and present it to the auditor with a couple of clicks from anywhere in the world.


Gain a high level of traceability

Gain cross-functional visibility and trace back to the root cause of each nonconformance.

“It’s very flexible, smooth, and easy to use. Documents no longer get lost and the whole history of all products is accessible for anyone at any time.”

Christian Schärfe Thomsen

Project Manager, Cortex

Frequently Asked Questions

What is a QMS tool?

By definition, a QMS tool refers to software, system, or element that helps you with your quality management. In the case of a quality management system software, this term can relate to the software as a whole or the specific modules of a quality management software that make your QMS more effective, easier, flexible, etc.

How does QMS software work?

A good QMS software typically acts as a tool for quality management that allows them to perform their tasks more efficiently, resolve problems with ease and spend less time preparing for audits or searching for documents.

What is the best quality management software?

Simply put, the best QMS software is the one that best matches your specific needs. For that reason, we go through demos of the software with our potential customers and ask lots of questions during the process to assure that we can provide the right fit.

What is enterprise quality management?

Enterprise quality management simply refers to a set of quality management tools within a business or an enterprise. When it comes to software, the term enterprise quality management software is often used interchangeably with electronic quality management system (eQMS), and they are both use the eQMS abbreviation. The eQMS then refers to software that can help companies with their quality management by allowing for faster workflows and easier traceability of documentation.

Ready to learn more?

To learn how you can make the most of SimplerQMS, request a free, personalized demo presentation.

SimplerQMS Demo Interface