/ montrium EQMS
Change Control Software

Change control software, made simple

Streamline your change management process from creation to successful implementation—all from a simple, cloud-based application. Drive quality and drastically reduce timelines throughout your change control process with an intelligent change management solution designed to streamline your change process from start to finish.

The change management solution made for leaner teams

Designed to lighten the workload of scaling life science organizations, Montrium’s change control software allows for the adjustment of the depth of evaluation associated with each change to match the level of associated risk. Use built-in templated forms to create change requests and simplify the change management workflow for your team. Easily route change requests for review or update, assigning tasks and electronically signing all in one central change control software.

Drive the fundamentals of change control in one place

Get behind the wheel of a powerful vehicle for change management, one that gets you where you want to go by empowering you to manage changes with intelligent workflows and monitor the progress of each request.

Centralized change control activities and content for easier change management

Automated workflows and notifications to slim down your to-do list and ensure a compliant process

Frictionless generation of time-stamped audit trails for regulatory compliance

Configurable reporting views and metrics to maintain practical oversight of changes

We have been extremely pleased with the guidance that we are being provided. We understood that it would be very important for us to find a platform that could grow with us as we progressed into Phase III.

Kimberly Swint

Manager of Clinical Trials Documentation

Streamline your change process

Montrium’s change control software automates and streamlines all the changes throughout the organization so that nothing is left to chance. Whether it’s capturing change rationale or planning communication, our cloud-based change management software will centralize this effort in one environment for all stakeholders to access.

Centralize change control management

Carry out change control processes and store all change control documentation in one centralized place.

Track change causation & rationale

Diligently document change control causation and rationale to ensure your entire team has the detail it needs to see the big picture.

Automated workflows & notifications 

Clear up your calendar thanks to a system that executes automated workflows and sends notifications for you.

Extend across use cases

Built as a flexible and powerful change control tool, leverage for major process change, new equipment, software and processes, and much more.

Configurable reporting views

See your change control progress in the way that makes the most sense for your environment with configurable reporting views.

Time-stamped audit trails

Effortlessly create a robust and time-stamped audit trail thanks to intelligent change form capturing.

Seamless change, effortless compliance

Our change control management solution comes loaded with smart features to help you weather the change process. Discover compliance features built for organizations just like yours.

Time-stamped audit trails

Effortlessly create a robust and time-stamped audit trails thanks to intelligent change management forms.

21 CFR Part 11 eSignatures

Ensure your records are compliant with 21 CFR Part 11 & Annex 11 compliant digital signatures built directly into our change control software.

Aligned with GxP requirements 

Effortlessly achieve GxP compliance with a system that’s purpose-built to align with and uphold the requirements. 

FAQs about our change control software

What is change control software?

Organizations that operate in regulated industries are required to put in place management tools that streamline the request, planning, and approval of change management processes. These processes are typically formalized in a change control software that is designed to centralize and secure change requests and the change control process in one location.

What are the different types of change control?

Within the context of change control software, we typically see there being two different categories of change: planned and unplanned changes.

Planned changes are executed with proper planning and a fixed timeline. For example, if a piece of equipment needs to be replaced with a new machine. In this case, the replacement process is planned before you begin the execution of the change.

Unplanned changes are unexpected and often require immediate action. For example, if a product is recalled from the market due to an issue or safety concern. This is considered an unplanned change. Both of these types of change management situation can be managed in Montrium change control software.

Can Montrium's change control software adapt to my needs?

All of Montrium's solutions have been engineered to be flexibile enough to adapt to most organizations' change control management processes. We provide you with a series of out-of-the-box functionalities and change management tools to help streamline submitting change requests.

Why is a change management solution critical for my organization?

Outside of formalizing your change management procedure and process as a regulatory expectation, change control software or a change management solution is an essential tool to track all changes. Whether your organization is managing a smaller number of changes like major and minor changes, or if your change management process is more robust and includes emergency changes, like-for-like changes and temporary changes, you need a place to show evidence of proper planning and traceability.

Are change control and change management the same?

Change management and change management software exist to manage the design change implementation processes. Change controls are the formalized in such a way that you'll document and ensure control management of the process, typically documenting the decision to make that change.

Connects to our other
QMS applications

Document Control Module

Make manual paper filing and excel trackers a thing of the past

Training Management Module

Get real-time oversight on training gaps and ditch tedious excel trackers and manual follow-up

Incidents & Deviations Module

Centralize and manage all quality events from report to action with full control.

CAPA Management Module

Centralize and manage all quality events from report to action with full control.

Change Control Module

Reduce the burden of make managing change in your organization with complete oversight and traceability

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Secure & private by default

We take the responsibility of helping you manage clinical trial data seriously. That’s why security and compliance are key focus areas for our organization and product development.

Rapid implementation & validation

Implementing software in the life sciences has changed dramatically.
Leverage our team of industry vets as we guide you from zero to eTMF hero in
as little as 4 weeks.

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