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:

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Full ISO, FDA, GxP, GMP compliance in audits

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50% time reduction on change management

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Increased efficiency and reduction in human error

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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
Works on Any Device

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

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Change Request Audit Trail in SimplerQMS

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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

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Automated CAPA Trending Report in SimplerQMS

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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.

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.

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Document Control

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Training Management

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Risk Management

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Design Control

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Change Management

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Supplier Management

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CAPA Management

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And much more…

Utilize Proven Technology

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

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Pass audit more easily

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

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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 Schärfe Thomsen

Project Manager, Cortex

See What Our Customers Have to Say

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“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

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“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

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“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

Ready to learn more?

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

SimplerQMS Demo Interface