Life Science Quality
Management Software

Comply with ISO, FDA, and GxP regulations and be audit-ready with our cloud-based quality management system.
Learn why life science organizations around the world trust SimplerQMS and achieve these results:

Full ISO, FDA, GxP, GMP compliance in audits

50% time reduction on change management

Increased efficiency and reduction in human error

Book a Demo
SimplerQMS Software Review Badges - 5

Join Over 4,300 Quality Professionals Who Trust SimplerQMS

Cook Medical Logo
Basic Pharma Logo
Berlin Cures Logo
Biograil Logo
Circuit Clinical Logo
Mediplast Logo
MEDIG logo
Minerva Imaging Logo

Ready to Use

Automated Workflows

Electronic Signatures

Pre-Validated eQMS

For Life Science Organizations

Fully Compliant

ISO 13485:2016 Certified Vendor

MDR and IVDR Ready

ISO, FDA, GMP, GxP Compliant

GAMP5 Pre-Validated

Simple to Use

Easy User Interface

Integrated with Microsoft Office

Automated Document Upload

Automated Document Upload

View all

Work Efficiently in Microsoft Office Suite

Get your organization up and running fast on SimplerQMS.

We seamlessly integrate our eQMS with the familiar Microsoft Office applications – Word, Excel, Outlook, and PowerPoint.

Editing Control Report in Microsoft Office Interface
Change Request Audit Trail in SimplerQMS

Out-of-the-Box Regulatory Compliance

We provide an audit trail, versioning, and eSignatures, which are ISO, GxP, MDR, and FDA Compliant.

SimplerQMS is pre-validated QMS software and is ready for audits and inspections. Furthermore, we ensure continuous re-validation of the system.

Streamline Your Training Management Activities

Using SimplerQMS, you can create, assign, and track employee training tasks with ease.

Ensure that relevant employees receive training activities based on their functional roles.

Employee Training Assignment Statuses in SimplerQMS
Automated CAPA Trending Report in SimplerQMS

Overview KPI Reports

Get an overview of your organization’s training compliance, trending CAPAs, Non-Conformances, Deviations, and Complaints by viewing KPI reports.

Understand where your organization stands on critical quality metrics and historical trends.

100% Transparent Pricing

With SimplerQMS you get everything for one subscription price, depending on the number of licenses.

There are NO implementation fees, extra charges for hosting, system validation, user training, ongoing support, or additional modules. It’s that simple.

Learn more about pricing

SimplerQMS Pricing Illustration

One Platform That Connects All Quality Processes

Our quality management software integrates all your quality processes, and stores data in centralized, cloud storage, allowing you to manage risks, audits, suppliers, etc., in a single system.

From document control, with time-stamped audit trails and the FDA 21 CFR Part 11 compliant electronic signatures, to CAPAs or any other quality event, with automated assigning of tasks and notifications, SimplerQMS helps you work more efficiently and maintain compliance with ISO, FDA, and GxP regulations.

Book a Demo

Document Control

Risk Management

Change Management

CAPA Management

Training Management

Design Control

Supplier Management

And much more…

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 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 photo

Christian Schärfe Thomsen

Project Manager, Cortex

What Our Customers Say

Capterra Logo
Star review

“Spending most of my day using SimplerQMS, I would say I am very pleased with the ease of use.”

Dorthe W.

QA/RA Manager, Cortex Technology

GetApp logo
Star review

“SimplerQMS gave us excellent pricing, customer support for understanding how to use their system and set up our QMS, and is easy to use.”

Subba S.

Chief Technology Officer, CollaMedix

Software Advice Logo
Star review

“Easy to work with. Intuitive. Rather easy to setup. Very good customer support. Good quality to price ratio.”

Jean Claude M.

Head of Hardware and Software Development, hemotune

See SimplerQMS in Action

To see SimplerQMS in action and learn how you can make the most of it, request a personalized demo presentation.

Book a Demo