Life Science Quality Management Software

Automate your processes in a fully-validated Life Science QMS software with document control, change control, training, CAPAs, and other QMS modules in one package.

document control qms for life sciences

All-In-One Solution

N

All eQMS Modules

N

Implementation

N

Support and Training

A

Fast Implementation

N

5-6 Weeks

N

Fully-Validated

N

Ready-To-Use Solution

Z

Regulatory Compliance

N

Full ISO, FDA, GxP, GMP Compliance

N

Audit-Ready

N

Fully-Validated

Trusted Technology

N

Microsoft Cloud

N

5000+ Customers

N

20+ Years on the Market

Explore SimplerQMS Modules

Click play and find out how SimplerQMS manages the following eQMS modules in real time.

We seamlessly integrate with familiar Microsoft Office applications – Word, Excel, Outlook, PowerPoint. Work on your documents in Microsoft Office and store them with one click in SimplerQMS Cloud.

With SimplerQMS you can automate your change control processes. Create change requests, assign them to specific documents and delegate new assignments with automatic e-mail notifications.

You can assign training activities to specific employees and easily see an overview of the learning progress. The system also automatically reminds you when the training needs to be redone.

See SimplerQMS in Action

Take a look at some of the major features of the SimplerQMS software. The three major DEMO videos can be seen down below.

Document Control

We seamlessly integrate with familiar Microsoft Office applications – Word, Excel, Outlook, PowerPoint. Work on your documents in Microsoft Office and store them with one click in SimplerQMS Cloud.

Change Management

With SimplerQMS you can automate your change control processes. Create change requests, assign them to specific documents and delegate new assignments with automatic e-mail notifications.

Training Management

You can assign training activities to specific employees and easily see an overview of the learning progress. The system also automatically reminds you when the training needs to be redone.

Full Regulatory Compliance

Document and Life Science Requirements

Avoid Time-Consuming Validation Processes

SimplerQMS is fully validated according to ISPE GAMP5 and is re-validated upon the creation of a new version or upon applying standard updates.

We do all the software validation for you – there are no additional expenses, resources, or time commitments to software validation on your part.

Have peace of mind with a system that complies with requirements regarding validation of systems used for QMS such as 21 CFR Part 11, and 820, EU GMP Annex 11, and ISO 13485:2016.

Illustration of Computer System Validation Requirements

What kind of validation documentation and evidence do we provide?

  • Validation Procedure
  • Validation Plan
  • Validation Report
  • IQ, OQ and PQ Documentation

Designed For Life Sciences

Medical Device & MedTech

Ensure compliance with medical device regulation standards and simplify your quality processes.

Pharmaceutical & BioTech

Optimize workflows and reduce human error with automated quality management processes.

Clinical & Medical Laboratories

Ensure regulatory compliance and efficacy in your laboratory’s operations.

Trusted by Companies Around the World

Cortex Logo - Black

Cortex Technology

Cortex Technology decreased the time spent on change management by 50% and increased task ownership.

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Cortrium

Cortrium recorded major productivity boosts and decreased the number of human errors.

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Reapplix

Reapplix team streamlined its quality processes and impressed auditors during their first digital audit.

Without SimplerQMS

Computer without quality management system
  • Time-Consuming Processes
  • Risk of Non-Compliance
  • High Chance of Human Error
  • Limited Documentation Access
  • Risk of Non-Validated System

With SimplerQMS

Computer with cloud based SimplerQMS quality management system software
  • Efficient Processes
  • Easier Compliance
  • Reduced Human Error
  • Securely Sign Documents Anywhere
  • Audit-Ready and Fully-Validated

What Customers Achieve With SimplerQMS

Utilize Proven Technology

Our QMS for life-sciences is built on Microsoft & M-Files Technology which serves over 5,000 customers worldwide.

Z

Pass Audits Easily

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

U

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

Global Offices

World map showing SimplerQMS global office locations

See SimplerQMS in Action

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

SimplerQMS Demo Interface