Pharmaceutical and Biotechnology

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New Collaborative Models Are Emerging

The pharmaceutical industry is undergoing significant changes with regulatory evolution, the patent cliff, and personalized medicine. Efficient and effective organizations rely more and more on computerized systems. Having an integrated technological landscape is key to reducing operational and system complexity. The ability to work with many individuals and organizations across the globe is also key as clinical trials and pharmaceutical manufacturing becomes more global.

New R&D models and the need to reduce the cost of drug development and manufacturing is pushing companies to find new and innovative organizational models. This in turn is increasing the outsourcing of clinical and manufacturing activities and development of collaborative partnerships. These models mean that we need to find new and more effective ways to collaborate as an industry and collaborative technology such as SharePoint provides us with a strong foundation.

We Know What’s Important to You!

Montrium Connect can help pharmaceutical and biotech companies improve traceability, control and collaboration around records and quality management. Our solutions are based on industry best practices and standards and are used by organizations large and small. Our focus is on connecting people and processes through our collaborative platform based on SharePoint technology. These solutions can be provided either through the Microsoft Azure cloud or on-premise. Montrium Connect can be used by internal and external teams, allowing efficient and traceable collaboration.

Montrium Connect is built on predefined configurations which are themselves based on regulatory requirements, industry standards and models and our deep experience in GxP environments. As a result, we can significantly reduce the overhead of deploying and configuring systems whilst also reducing the amount of time before you can start benefitting from our system. Montrium Connect is built with your needs in mind and will help you gain competitive edge as you evolve with the new work paradigm in pharmaceuticals.

  • Improve collaboration and traceability with all stakeholders
  • Centralize all records and information in one place
  • Drive processes automatically and improve efficiency
  • Optimize virtual teams and operations
  • Provide real-time insight with dashboards and navigators

What our clients say about us

Montrium played a pivotal role in our efforts to formalize our Document Management and Quality Management Systems. Their team provided expert feedback during the design and configuration phases and continues to provide exceptional customer support services.

Sandra Chiovitti, InSymbiosis

Our Solutions for Pharma & Biotech

Our solutions have been built with Pharmaceuticals and Biotechnology organizations in mind. They work together to provide a complete regulated content and records management solution which is easy to implement and get up and running within your organization so that you can realize the benefits quickly.

eTMF Connect

eTMF Connect – The Smart Way to Manage TMF Content

Montrium’s proven eTMF Connect solution helps life science companies better manage their clinical trial documentation. It has been designed using the TMF Reference Model, and centralizes and standardizes your clinical records enabling both sponsors and CRO’s to contribute and access important clinical documents and information in real-time.

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RegDocs Connect – Automate the Creation of Submission-Ready Content

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.

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SOP Connect Automate the entire lifecycle of your controlled documents

SOP Connect – Automate the entire lifecycle of your controlled documents

Montrium’s SOP Connect module is designed to manage all controlled documents that form part of your quality system. Easy access, centralized distribution, intuitive workflows and strong integration with our Training Connect module ensure that quality and compliance are at the heart of your operations.

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Training Connect Facilitate the planning and completion of GxP Training

Training Connect – Facilitate the Planning and Completion of GxP Training

Training Connect facilitates the planning and completion of SOP or regulatory training. An integrated training matrix coupled with intelligent form technology allows you to track and manage employee training more efficiently, ensuring that you meet all training requirements.

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CAPA Connect Centralizing and Empowering Continuous Improvement

CAPA Connect – Centralizing and Empowering Continuous Improvement

CAPA Connect is an integrated deviation, incident and CAPA management solution which allows you to manage all of your quality events in one central location. CAPA Connect has intuitive forms and workflows which adapt based on the type of quality event being managed.

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