Document Control Software

Automate and standardize your document control activities with ease.

Document Management Software Interface

Work efficiently in Microsoft Office

Get your organization up and running fast on SimplerQMS. We seamlessly integrate with the familiar Microsoft Office applications – Word, Excel, Outlook, and PowerPoint. Work on your documents in Microsoft Office and store them with one click in SimplerQMS Cloud. Documents are automatically named, numbered, and versioned. This will save you time, improve your documentation structure and provide a better overview.


Out-of-the-box regulatory compliance

SimplerQMS ensures compliance with the relevant standards and regulations in the life science industry. We provide an audit trail, versioning, and e-signatures, which are 21 CFR Part 11 and GxP Compliant. Furthermore, SimplerQMS is pre-validated and certified according to ISO13485:2016. This means that your organization can avoid paper documentation and manage any record electronically in SimplerQMS.


Standardize documentation processes

Enforce the use of standardized and approved forms which are created by Microsoft Office. This allows users to easily draft new documents such as instructions, supplier reviews, design records, complaints, and CAPA’s based on your customized forms.

Automate and enforce document access

Ensure that the right people have access to the right documents. Access rights are automatically set on each document and can be controlled on many levels such as by Role, Site, Project, and Department.

Simplify review and approval processes

Automated workflows ensure that the relevant persons are notified when they are assigned a task such as a document review or approval. Tasks are easily tracked through customizable Dashboards and Notifications. This allows you to quickly gain an overview of documentation status. Finally, let any internal or external person sign documents with our built-in Part 11 Compliant eSignatures. This means no more chasing signatures and manual circulation of documents.


The SimplerQMS modules cover all your processes

No matter if your life science organization is a start-up or a later stage company, our integrated modules cover your needs. All modules are included in the SimplerQMS Subscription and you get to choose when they should be implemented.

Training Management Module Icon

Training Management

Save time with automated training activities, learning overview, reminders, and generation of training certificates.

CAPA Management Module Icon

CAPA Management

Identify, uncover, resolve, and report all the preventative actions and corrective actions (CAPAs) seamlessly.

Complaint Management Module Icon

Complaint Management

Reduce the associated risks and resolve issues quickly by optimizing complaint, nonconformance, and deviation processes.

Change Management Module Icon

Change Management

Recognize and manage all changes accordingly to ensure compliance and structure within your organization’s QMS.

Design Control Module Module Icon

Design Control

Manage all the necessary processes related to product design and meet Design Control requirements with ease.

Document Management Module Icon

Document Control

Automate and standardize your document control activities with ease.

Equipment Management Module Icon

Equipment Management

Have an overview of your equipment and handle tasks in an organized manner.

Electronic Signature Module Icon

Electronic Signatures

Sign and send the necessary documents for authoring, review, approval, from anywhere in the world, at any time.

Product Management Module Icon

Product Management

Plan and organize all your product management activities and integrate them with other processes.

Post-Market Surveillance Module Icon

Post-Market Surveillance

Remain in compliance and monitor the safety and the performance of the product in the market.

Risk Management Module Icon

Risk Management

Consolidate risk and handle your risk management file in a well-organized and structured manner.

Supplier Management Module Icon

Supplier Management

Simplify supplier-related activities and handle your supplier documentation following the standards.

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