Montrium Connect Integrations

Enterprise Quality Management Software in cloud for life sciences. Technology plays a crucial role in ensuring that QA is aware of any issues as they arise in today's complex operational environment. You can gain insight into your quality management system's performance and the current state in your operation to be more proactive and reduce risk. Montrium's Enterprise Quality Management system (EQMS), was designed to help life science companies tackle the content management challenges they face head-on. Each module of the SharePoint QMS can be used separately or as part of a fully integrated quality management platform. These modules can be used on-premise or in a cloud environment. These modules are ideal for pharmaceutical companies, contract manufacturers, and medical device companies. Built to comply with GMP/GCP requirements.

The new eTMFConnect is now available. Simplicity without compromise. We have re-engineered eTMF Connect to make it more scalable, faster, and more efficient for today's clinical trial environment. Improved Data Visualizations and Reporting Views. Montrium now provides a variety of new data visualizations and reporting tools integrated into eTMFConnect, allowing for more powerful business intelligence applications. Project teams and clinical operations managers will have greater visibility into TMF quality, timeliness, and completeness with better functionality. These improvements will help you elevate your TMF strategy across clinical programmes. Every clinical trial is different. The subtle nuances and regional differences can add layers of complexity that can keep even the most skilled TMF professional awake at night. Your eTMF platform must be flexible enough to handle these nuances and differences.

RegDocs Connect provides the tools for your regulatory and operational teams to create compliant, submission-ready documents and records. This solution is built with the end user in view. It focuses on collaboration, automation, and quality. Automated workflows allow you to manage your records from draft to final. This allows your team to have complete control over your regulatory documents at any time. The mapping of document types to the EDM Reference Model and eCTD allows for organization and retrieval of documents that can be used in regulatory submissions. The powerful tools of PDF/A Publishing, document classification, unique document identifiers, and EDM reference model facilitate regulatory document management. This solution pulls together information from all levels of your organization into one easy-to-use solution. The ability to produce submission-ready and quality content has become more difficult due to electronic submissions to regulatory authorities and the complexity of drug development.