Montrium Connect Integrations

Enterprise Quality Management Software in the cloud for the life sciences. In today’s complex operational environment, technology plays a vital role in ensuring that QA is made aware of the issues as they happen. Gaining insight into the performance of your quality management system and the current state of your operation helps you to be more proactive, which minimizes risk and eliminates costly delays. Montrium has designed its Enterprise Quality Management system (EQMS) to enable life science companies to tackle the quality challenges that they face in content management head-on. All of our SharePoint QMS modules can be used independently or together as a fully integrated quality management system. These modules are available as part of our Montrium Connect Platform and can be deployed on-premise or in the cloud. Perfect for pharmaceutical companies, contract manufacturing organizations, medical device companies. Built to achieve compliance with GMP and GCP requirements.

Introducing the new eTMF Connect. Simplicity Without Compromise. We’ve re-engineered eTMF Connect for a faster, more scalable and higher performing eTMF solution for today and tomorrow’s clinical trial environment. Improved Data Visualizations & Reporting Views. Montrium now offers a range of new data visualization and reporting tools embedded into eTMF Connect, providing more powerful business intelligence applications. With functionality that provides better insight across all of your studies, project teams and clinical operations managers can have increased visibility on TMF completeness, quality, and timeliness. Together, these improvements will elevate your TMF strategy across clinical programs. No clinical trial is the same, and the subtle nuances and regional differences add layers and layers of complexity that can keep even the most experienced TMF professional up at night. Your eTMF platform needs to be flexible enough to manage these differences and nuances.

RegDocs Connect gives your operational and regulatory teams the tools they need to prepare complete and compliant submission ready documents and records. Built with the end user in mind, collaboration, automation and quality are the foundation of this solution. Automated workflows manage your records lifecycle from draft to final, enabling your team to be in complete control of your regulatory documents at all times. Mapping of document types to the EDM reference model and eCTD facilitates organization and retrieval of documents for inclusion in regulatory submissions. Proprietary tools such as PDF/A Publishing, document classification, and unique document identifiers provide a powerful regulatory document management solution that pulls information from across your organization, into one manageable solution. With the rise of electronic submissions to regulatory agencies and the increased complexity of drug development, the ability to produce submission-ready, quality content