Life Science Quality Management Software

Automate your processes in a fully-validated Life Science eQMS with document control, training management, CAPAs, and other eQMS modules all 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

See SimplerQMS in Action

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

SimplerQMS main life science quality management regulations

Avoid Time-Consuming Validation Processes

SimplerQMS is a fully-validated life-science eQMS. This means that there are no additional costs, resources, or time allocated to software validation on your side.

Additionally, we validate our quality management system software every month to ensure top-notch compliance.

 

Life Science Validation Requirements

What kind of validation documentation and evidence do we provide?

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

Trusted by Companies Around the World

Medical Device

cortex dermalab product

Case Study: Cortex

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

Medical Device

cortrium case study image for the landing page

Case Study: Cortrium

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

BioTech

reapplix case study image

Case Study: Reapplix

Reapplix team was able to streamline their quality processes and impress 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

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