Regulatory Document Management Software (rDMS) for Life Sciences

Manage all your regulatory documents in one centralized database. Author, review, approve, and track regulatory documentation with ease.

ISO 9001 Document Search Inside SimplerQMS


Streamline Regulatory Document Management in Your Organization.

Search ISO 9001 Documents in SimplerQMS

Click to Enlarge Image

Ensure a Unified Access to All Regulatory Documents

Effective document control is essential to any regulatory environment, as it helps organizations achieve efficiency in their operations while maintaining compliance.

With SimplerQMS regulatory document management software (rDMS) you can store all your regulatory documents in one centralized place for easy and quick access by authorized personnel with the appropriate permissions.

Search for documents using an advanced “Google-like” search feature and find the right document easily, even if you don’t know its exact location. Plus, cloud-based deployment provides users with access to the system from anywhere, at any time.

Facilitate an Entire Regulatory Documentation Lifecycle

Take advantage of automated workflows for the creation, review, approval, distribution, escalation, and archiving of regulatory documents in a complaince and efficient manner.

Assign documents to specific users or groups for review and approval, track the status of each document, and receive notifications and reminders when a task is due. Track document versions, revision histories, and document status throughout the entire process to ensure that everyone is always working on the most up-to-date version of a document.

Furthermore, SimplerQMS allows you to access full, time-stamped audit trails, create documents based on predefined templates, edit documents in familiar Microsoft Office applications, and approve documents using eSignatures.

Change Request Audit Trail in SimplerQMS

Click to Enlarge Image

SOP Being Signed With Electronic Signature in SimplerQMS

Click to Enlarge Image

Meet Complex Regulatory Requirements With Ease

SimplerQMS is purposefully built to meet the specific needs of highly regulated life science industries such as medical device, pharmaceutical, biotechnology, and others.

The software helps manage documents related to quality management, clinical operations, regulatory affairs, and more, in a secured and controlled manner to ensure compliance with FDA regulations, ISO standards, and other requirements.

Moreover, SimplerQMS provides a fully 21 CFR Part 11 compliant document management solution, which means that it meets the stringent requirements for electronic records and signatures set forth by the U.S. Food and Drug Administration (FDA).

Combine Regulatory and Quality Data in a Single Platform for Greater Efficiency

In today’s fast-paced and ever-changing regulatory environment, life science organizations need to be able to move quickly and efficiently.

With SimplerQMS you can manage both RA and QA documents in one system and get a complete picture of your organization’s compliance posture. We provide a broad QMS process support, so you can not only manage regulatory documents, but also quality control plans, NCs and deviations, CAPAs, suppliers, employee training, audits, and more.

Plus, you can integrate SimplerQMS with third-party software applications such as your ERP, CRM, or LIMS system through our API to further streamline your business processes.

Change Request Relations in Simplerqms

Click to Enlarge Image

eQMS That Goes Beyond Document Management

Document Control

Automate the creation of documents, the review and approval of documents, and the distribution of documents.

Change Control

Ensure that all changes to documents are tracked, reviewed, and approved according to your QMS.

Audit Management

Easily prepare for, conduct and document audits with an integrated audit management module.


Track and manage non-conformances throughout your organization with ease.

CAPA Management

Investigate root causes and implement corrective actions to prevent issues from happening again.


Manage customer complaints from start to finish and ensure timely resolutions.

Frequently Asked Questions

What is a Regulatory Document Management System (rDMS)?

Regulatory document management software (rDMS) is a software application designed to help life science organizations to manage regulatory documents.

The software enables users to author, review, approve, distribute, and archive documents in a controlled, efficient, and secure manner. Regulatory DMS software allows organizations to streamline their regulatory document lifecycle from creation to submission and obsolescence while ensuring compliance with regulatory authorities.

What Are the Benefits of Regulatory Document Management Software?

There are many benefits of using Regulatory DMS software including improved compliance with regulatory authorities, faster document lifecycle times, greater efficiency and productivity, reduced risks associated with manual processes, and more enhanced security and control over documents.

What Makes SimplerQMS Regulatory Document Management Tools Popular?

Popular features of SimplerQMS Regulatory Document Management Tools include:

  • Controlled document workflows
  • Version controls and document history
  • User access controls and permissions
  • Full audit trail of all document changes
  • Centralized, cloud-based, repository with easy search and retrieval
  • FDA 21 CFR Part 11 compliant electronic signatures
  • Broad QMS process support
  • Integration with third-party software applications
  • Access to documents from any device

Are SimplerQMS Document Management Tools Validated?

All of SimplerQMS’s software tools are pre-validated and compliant with the requirements of GxP Guidelines, FDA 21 CFR Part 11, and ISO 13485:2016.

We also provide extensive validation evidence for use during audits and inspections. This includes our validation plan, procedure, report, as well as, IQ, OQ, and PQ documentation.

Plus, we ensure continuous re-validation of our software tools to maintain compliance which is something many other software providers do not offer.

How Much Does SimplerQMS Document Management Solution Cost?

SimplerQMS’s regulatory document management is part of an all-in-one QMS software solution. This includes all QMS modules (document control, change control, audits, NCs, CAPAs, suppliers, training, etc.), system implementation, training, ongoing support, continuous re-validation, hosting, and more.

This means that everything is included in the price you pay and there are no other costs associated with subscribing to SimplerQMS.

To learn more about our pricing, please contact us for a demo and price quote.

What Customers Achieve With SimplerQMS

Utilize Proven Technology

SimplerQMS is built on Microsoft & M-Files Technology which serves over 5,000 customers worldwide.


Pass audit more easily

Access needed documentation and present it to the auditor with a couple of clicks from anywhere in the world.


Gain 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

See What Our Customers Have to Say

Capterra Logo
Capterra Logo

“Spending most of my day using SimplerQMS, I would say I am very pleased with the ease of use.”

Dorthe W.

QA/RA Manager, Cortex Technology

Capterra Logo
Capterra Logo

“SimplerQMS gave us excellent pricing, customer support for understanding how to use their system and set up our QMS, and is easy to use.”

Subba S.

Chief Technology Officer, CollaMedix

Capterra Logo
Capterra Logo

“Easy to work with. Intuitive. Rather easy to setup. Very good customer support. Good quality to price ratio.”

Jean Claude M.

Head of Hardware and Software Development, hemotune

See SimplerQMS in Action

To see SimplerQMS in action and learn how you can make the most of it, request a personalized demo presentation.

SimplerQMS Demo Interface