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.
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.
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
Kimberly Swint
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.
Carry out change control processes and store all change control documentation in one centralized place.
Diligently document change control causation and rationale to ensure your entire team has the detail it needs to see the big picture.
Clear up your calendar thanks to a system that executes automated workflows and sends notifications for you.
Built as a flexible and powerful change control tool, leverage for major process change, new equipment, software and processes, and much more.
.webp)
See your change control progress in the way that makes the most sense for your environment with configurable reporting views.
Effortlessly create a robust and time-stamped audit trail thanks to intelligent change form capturing.
%201.webp)
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.
Effortlessly create a robust and time-stamped audit trails thanks to intelligent change management forms.
Ensure your records are compliant with 21 CFR Part 11 & Annex 11 compliant digital signatures built directly into our change control software.
Effortlessly achieve GxP compliance with a system that’s purpose-built to align with and uphold the requirements.
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.
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.
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.
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.
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.
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.
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.
Fill out the short form below to schedule a live demonstration
You’re one click away from getting all of Montrium's award-winning content sent directly to your inbox
