Facilitate and Speed Up the Product Release Process
Outsourcing of GMP manufacturing to Contract Manufacturing Organizations (CMOs) is on the rise. CMOs can typically support clients from development through to commercial manufacturing, often at a lower cost. CMOs also play an important role in being able to provide manufacturing services globally. Management of methods, specifications and documentation is at the core of the activities undertaken by CMOs for Pharmaceutical clients. Being able to access the most up to date specifications or being able to post batch records and COAs for review and approval online can greatly facilitate and speed up the product release process.
Montrium Connect’s Record Management solutions have preconfigured libraries for the creation and management of all records related to GMP activities. Our solution has full version control and change management features which greatly facilitate the update and distribution of GMP documents.
We Know What’s Important to You!
As pharmaceutical manufacturing is more and more decentralized or outsourced, it is important that we are able to centralize controlled documents in one place to ensure an optimal manufacturing process. Montrium Connect provides both pharmaceutical companies and contract manufacturers with a centralized platform to create and distribute specifications, methods, master batch records and other controlled documents for use during the manufacturing process. Execution documents such as executed batch records and CoAs can also be uploaded and reviewed centrally to ensure timely release of product.
Regulatory and quality system documents can also be managed in one central place facilitating authoring, versioning, access and submissions. Finally we are able to provide an online enterprise quality system which allows easy logging of all incidents and deviations and the management of CAPAs in real-time for all stakeholders, significantly improving cross organization quality management and reporting.
- Centrally manage all controlled documentation in one location
- Perform batch review and release online
- Log and manage quality issues, incidents and deviations with all stakeholders
- Proactively manage quality-related problems with real-time reporting
Our Solutions for Manufacturing Organizations
Our solutions have been built with Pharmaceuticals and Biotech 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.
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.
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.
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.