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.