Regulatory Information Management Software (RIMS) for Life Sciences

Effectively manage all your regulatory activities and deliver safe products to market faster.

Changes Related to Quality Processes Inside SimplerQMS


Generate Compliant, Error-Free Regulatory Submission Documentation.

Search ISO 9001 Documents in SimplerQMS

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Manage All Your Regulatory Information in a Single Platform

Nowadays, Regulatory Affairs teams operating in life science industries, such as medical devices, pharmaceuticals, biologics, and others, are tasked with managing an ever-growing amount of data and documentation. This can be daunting, especially when using multiple software systems to store and manage this data.

SimplerQMS Regulatory Information Management System (RIMS) provides a cloud-based solution for managing all your regulatory information in a single platform.

Role-based access control ensures that only authorized users have access to the data they need.

Seamlessly Collect Your Product Information Into Technical Dossiers

Collect and organize all the needed product information you need to submit product submissions for each global agency in their regulated formats.

Add submission-specific metadata to each file, so you can always find the right one quickly and easily. Relate product-related documents to multiple archives, for various regulatory submissions and avoid duplication of the same file.

When it’s time to compile your technical dossiers, such as electronic Common Technical Document (eCTD) dossiers – make a snapshot of current documentation for each product and share it externally.

eCTD Document Collection in SimplerQMS

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SOP Audit Trail in SimplerQMS

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Automate and Streamline Regulatory Processes

Utilize controlled document workflows for document creation, routing, review, approvals, and escalation.

SimpleQMS fulfills regulatory requirements set forth by FDA 21 Part 11 and provides a complete, time-stamped audit trail for all document changes, version control, and electronic signatures.

Monitor and track the progress of individual tasks and activities with our visual workflow status feature. Take advantage of automatic email notifications and reminders to keep everyone informed, and never miss a regulatory deadline again.

Connect Regulatory Information Management (RIM) With Your QMS

SimplerQMS allows you to integrate the Regulatory Information Management System (RIMS) solution with your Quality Management System for a single source of truth.

For example, relate product registration records to the quality control procedures used for that product, or link clinical trial data to the marketing authorization application.

By integrating your Regulatory and Quality processes, you can avoid duplication of effort, save time, and manage all your quality and compliance-related activities in one place!

Change Related to Quality Processes in SimplerQMS

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eQMS That Streamlines Quality & Regulatory Compliance

Document Control

Streamline the lifecycle of documents, from authoring and review to approval, storage and obsolescence.

Change Control

Manage changes to documents, processes, and products with workflows that ensure timely approvals.

Audit Management

Plan, schedule, conduct, and track audits with ease, and ensure follow-ups on audit findings.

Employee Training

Track and manage employee training records, including expirations and renewals.

CAPA Management

Efficiently manage your Corrective and Preventative Actions (CAPAs) from start to finish.

Risk Management

Identify, assess, and mitigate risks across your organization with our risk management module.

Frequently Asked Questions

What is a Regulatory Information Management System (RIMS)?

A Regulatory Information Management System (RIMS) is a software solution that helps life science organizations manage their regulatory product information more efficiently and effectively.

The software enables organizations to collect, track and manage product dossiers and helps prepare for regulatory submissions, approvals, and product registrations in the required formats set forth by global regulatory agencies.

What Are the Features of RIMS Software?

Some of the core features of an effective RIMS software include:

  • Automated document workflows
  • FDA 21 CFR Part 11 electronic signatures
  • Time-stamped audit trails
  • Version control and document change tracking
  • User access controls and permissions
  • Automated email notifications, task reminders, etc.
  • Ability to collect & organize regulatory product information

Are SimplerQMS RIMS Software Tools Validated?

Yes! SimplerQMS provides a pre-validated software solution that complies with the requirements of FDA 21 CFR Part 11, GxP, and ISO 13485:2016. This allows our customers to have peace of mind knowing that our software is compliant with industry standards.

We ensure continuous re-validation of the software, every month, and provide extensive validation evidence. This includes our validation plan, procedure, reports, IQ, OQ, and PQ documentation.

Is SimplerQMS RIM System Software FDA 21 CFR Part 11 Compliant?

Yes, SimplerQMS RIMS software is 21 CFR Part 11 compliant, as it is designed to help organizations operating within life sciences comply with the Electronic Signature and Digital Record practices set forth by the FDA 21 CFR Part 11.

How Much Does SimplerQMS RIMS Software Cost?

SimplerQMS RIMS solution is part of an all-in-one QMS software.

This includes support for all the core QMS system modules, system implementation, online training, ongoing support, continuous re-validation, cloud 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

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“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

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“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

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“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