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Submitted URL: https://gosimplerqms.com/
Effective URL: https://simplerqms.com/
Submission: On August 10 via api from BE — Scanned from NL

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data in our Privacy Policy.

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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.

Book a Demo





ALL-IN-ONE SOLUTION

N

All eQMS Modules

N

Implementation

N

Support and Training

Learn more
A


FAST IMPLEMENTATION

N

5-6 Weeks

N

Fully-Validated

N

Ready-To-Use Solution

Learn more
Z


REGULATORY COMPLIANCE

N

Full ISO, FDA, GxP, GMP Compliance

N

Audit-Ready

N

Fully-Validated

Learn more



TRUSTED TECHNOLOGY

N

Microsoft Cloud

N

5000+ Customers

N

20+ Years on the Market

Learn more


EXPLORE SIMPLERQMS MODULES

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


 * Document Control
 * Change Management
 * Training Management

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.

Explore all modules


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.

Explore all modules


FULL REGULATORY COMPLIANCE

SimplerQMS is fully validated according to GAMP5 and complies with FDA 21 CFR
Part 11 and EU GMP Annex 11.

The system supports compliance with various Life Science requirements, such as
GxP, ISO 13485:2016, FDA 21 CFR Part 210, 211, 820, ICH Q10, EU MDR and IVDR,
ISO 9001:2015, and others.

Our customers have completed more than a hundred successful audits and
inspections using SimplerQMS.

See certification & compliance



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.




WHAT KIND OF VALIDATION DOCUMENTATION AND EVIDENCE DO WE PROVIDE?

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

Recommended Reading: QMS Software Validation: When Is It Needed?


DESIGNED FOR LIFE SCIENCES



MEDICAL DEVICE & MEDTECH

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

Explore solutions


PHARMACEUTICAL & BIOTECH

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

Explore solutions


CLINICAL & MEDICAL LABORATORIES

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

Explore solutions


TRUSTED BY COMPANIES AROUND THE WORLD

CORTEX TECHNOLOGY

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

Read case study

CORTRIUM

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

Read case study

REAPPLIX

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

Read case study
Read customer case studies


WITHOUT SIMPLERQMS


 * Time-Consuming Processes
 * Risk of Non-Compliance
 * High Chance of Human Error
 * Limited Documentation Access
 * Risk of Non-Validated System


WITH SIMPLERQMS


 * 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

With offices across 3 continents, we have the capability to offer truly global
service and support.

Explore our global offices


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


Product

Overview

Implementation

Compliance

Pricing

Solutions

For Medical Device & Tech

For Pharma & BioTech

For Laboratory

See All Modules

Company

About Us

Contact Us

Contact Support

Experience

Careers

Resources

Case Studies

Blog

Newsletter

Consultants

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