€ 895 /mo

Includes Implementation, Validation, All Modules, Training & Hosting.

The SimplerQMS Subscription is All-Inclusive

There is no implementation fee or other costs associated with subscribing to SimplerQMS.

Full implementation

  • Full eQMS Implementation
  • Pre-Validated System
  • Dedicated Project Manager

Secure Platform & Hosting

  • Unlimited Support
  • Desktop, Web, Mobile App
  • Secure Cloud Hosting

Life Science Compliance

  • ISO 13485:2016 Certified Vendor
  • 21 CFR Part 11 Compliant
  • ISO 13485:2016 Compliant

Life Science Modules

  • Document Control
  • SOP Management
  • Training & HR Management
  • User Training, Dedicated Trainer
  • ISO 13485:2016 Template Pack
  • 21 CFR Part 820 Template Pack
  • Document Migration
  • 200 GB Storage
  • Azure (AD) Integration
  • Backup & Disaster Recovery
  • Software Updates
  • 21 CFR Part 820 Compliant
  • ISO 14971:2019 Compliant
  • GxP Compliant
  • Annex 11 and GAMP5 Compliant
  • EU MDR & EU IVDR Compliant
  • ISO 9001:2015 Compliant
  • Audit Assistance
  • Ongoing Regulatory Surveillance
  • ISO 9001 Certified Hosting
  • ISO 27001 Certified Hosting
  • ISO 27018 Certified Hosting
  • Template Management
  • Supplier Management
  • Design Control
  • Risk Management
  • Change Control
  • Issues & CAPA Management
  • Audit Management
  • Product Management
  • Equipment Management
  • Production Records
  • Assignment Management

Full implementation

  • Full eQMS Implementation
  • Pre-Validated System
  • Dedicated Project Manager
Show More
  • User Training, Dedicated Trainer
  • ISO 13485:2016 Template Pack
  • 21 CFR Part 820 Template Pack
  • Document Migration

Secure Platform & Hosting

  • Unlimited Support
  • Desktop, Web, Mobile App
  • Secure Cloud Hosting
Show More
  • 200 GB Storage
  • Azure (AD) Integration
  • Backup & Disaster Recovery
  • Software Updates

Life Science Compliance

  • ISO 13485:2016 Certified Vendor
  • 21 CFR Part 11 Compliant
  • ISO 13485:2016 Compliant
Show More
  • 21 CFR Part 820 Compliant
  • ISO 14971:2019 Compliant
  • GxP Compliant
  • Annex 11 and GAMP5 Compliant
  • EU MDR & EU IVDR Compliant
  • ISO 9001:2015 Compliant
  • Audit Assistance
  • Ongoing Regulatory Surveillance
  • ISO 9001 Certified Hosting
  • ISO 27001 Certified Hosting
  • ISO 27018 Certified Hosting

Life Science Modules

  • Document Control
  • SOP Management
  • Training & HR Management
Show More
  • Template Management
  • Supplier Management
  • Design Control
  • Risk Management
  • Change Control
  • Issues & CAPA Management
  • Audit Management
  • Product Management
  • Equipment Management
  • Production Records
  • Assignment Management

License types

SimplerQMS offers three license types:

Read Documents

Sign Documents

Create Documents

Edit Documents

Multiple User License*

Named User

Concurrent User

Read and Sign User

*Can only be used by one user at a time

Named User

  • Read Documents
  • Sign Documents
  • Create Documents
  • Edit Documents

Concurrent User

  • Read Documents
  • Sign Documents
  • Create Documents
  • Edit Documents
  • Multiple users *

*Cannot be used by multiple users simultaneously

Read and Sign User

  • Read Documents
  • Sign Documents

Frequently asked questions

How long does it take to implement SimplerQMS?

We take pride in helping our clients launch and start using SimplerQMS quickly. The average implementation time is 6 weeks.

What type of support does SimplerQMS offer?

Support by email, phone and video calls is included in the SimplerQMS Subscription. We take pride in offering high-quality and timely support to our clients. Our goal is that you and your colleagues are able to work in SimplerQMS with as few interruptions as possible.

Are there any hidden costs?

No – there are no additional costs, everything is included in the price you pay. Starting from the implementation process to application support, cloud capacity, and continuous updates. You only pay for the number of licenses you choose to purchase.

Is the training and validation included?

Yes – the training, as well as the whole implementation process is included in the subscription price. Furthermore, SimplerQMS is pre-validated, which means that you will no have to spend time on validation activities.

Are the relevant QMS template packages included?

Yes – the subscription price includes the quality manual, procedures, forms, and instructions. All templates are compliant with ISO 13485:2016, 21 CFR Part 820, and have gone through the audit process multiple times.

What happens with my data if I decide to cancel my subscription?

If you decide to leave SimplerQMS, you can easily export all your documents and files including a document index. All the files will be transferred to your computer in an easily accessible structure.

What type of user would use a "Named User" license?

A Named User license is a Personal User license, reserved for a specific user. It is ideal for “heavy-users” that need daily editor access.

What type of user would use a "Concurrent User" license?

A Concurrent User license can be shared by multiple users, however, it can only be used by one user at a time. It is a perfect solution for “light-users” that only occasionally need editor access.

What type of user would use a "Read & Sign User" license?

A Read & Sign user license is a Personal User license that allows for reading and signing documents. It also allows for signing Read & Understood training activities.

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