A plan for every organization

All plans align with the latest Life Science regulatory standards and regulations, including the FDA 21 CFR Part 11, EU GMP Annex 11, GxP, ISO 13485, ISO 9001, ICH Q10, FDA 21 CFR Part 210, 211 and 820, EU MDR and IVDR, and more.

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Basic Pharma Logo
Berlin Cures Logo
Biograil Logo
Dynamic Code Logo
Mediplast Logo
MEDIG logo
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Pricing

SimplerQMS Plans

All-inclusive subscription.

Starter

For small teams looking to get started with streamlining their QMS processes.

5-10 users

Get a Demo and Pricing

Starts at $1,200/month

All eQMS modules
Full system implementation
Full system implementation
Fully validated system
Continuous re-validation
Dedicated project manager
User training
Cloud-hosting
Integrations to other enterprise solutions

Team & Enterprise

Everything you need for an eQMS software implementation.

10+ users

Get a Demo and Pricing

Book a Demo for a price estimate

All eQMS modules
Full system implementation
Full system implementation
Fully validated system
Continuous re-validation
Dedicated project manager
User training
Cloud-hosting
Integrations to other enterprise solutions

All eQMS modules

Full system implementation

Fully validated system

Continuous re-validation

Dedicated project manager

User training

Cloud-hosting

Integrations to other enterprise solutions

Complete List of Features and Services

Full Implementation

Full eQMS Implementation

Fully Validated System

Dedicated Project manager

User Training, Dedicated Trainer

ISO 13485:2016 Template Pack

21 CFR Part 820 Template Pack

Document Migration

Secure platform & Hosting

Desktop, Web, Mobile App

Secure Cloud Hosting

Microsoft Office Integration

Microsoft Entra ID Integration

Integration to CRM, ERP, Jira, etc.

200 GB Storage

Backup & Disaster Recovery

Software Updates & Support

Electronic Signatures

Task Scheduling

Email Remainers

Data & Content Export

Search & Content Indexing

System Audit Trails

Life Science Compliance

ISO 13485:2016 Certified Vendor

21 CFR Part 11 Compliant

ISO 13485:2016 Compliant

GxP Compliant

21 CFR Part 820 Compliant

ISO 14971:2019 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

Quality Management

Training Management

CAPA Management

Template Management

Issue / PMS Management

Audit Management

Change Control

Design Control & Collection

Risk Management

Equipment Management

Supplier Management

Product Management

Customer Management

Process & Project Management

Electronic Batch Records

Regulatory Standard Mgmt.

Agreement Management

Reporting / Dashboards

SimplerQMS License Type Overview

Single-User License

Users per License:

One user per license

Usage Frequency:

Frequent

Examples:

QA, engineers, managers

Read Documents

Sign & Approve Documents

Training Read & Understood

Quiz Completion

Create & Edit Documents

Shared License

Users per License:

Unlimited users

Usage Frequency:

Less frequent

Examples:

Issue handlers, production

Read Documents

Sign & Approve Documents

Training Read & Understood

Quiz Completion

Create & Edit Documents

Note: One user can be logged in at a time for each Shared License.

Read & Sign License

Users per License:

One user per license

Usage Frequency:

Less frequent

Examples:

Production, top management

Read Documents

Sign & Approve Documents

Training Read & Understood

Quiz Completion

Create & Edit Documents

SimplerQMS License Types Explainer Video

Frequently Asked Questions

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

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.

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.

Yes – the training, as well as the whole implementation process is included in the subscription price.

Furthermore, SimplerQMS is fully validated, which means that you will not have to spend time on validation activities.

Yes – the subscription price includes templates for the quality manual, procedures, forms, and work instructions. All templates are based on Life Science requirements and have gone through the audit process multiple times.

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.

A Single-User license is a Personal User license, reserved for a specific user. It is ideal for users who need daily editor access.

A Shared 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 users who only occasionally need editor access.

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

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