The majority of currently used Document Management Systems is fossilized in many companies while the need for integral companies’ business processes increased. The next generation of DMS builds integral processes around products, not documents leveraging product data. Document Management needs to be part of an Integral Regulatory and Quality Information Management solution that supports Marketing Authorizations and orchestrated by easy to apply Change Controls on any level, enabling self-validation of the system.
The border between document, submission, and data management is disappearing due to the granularity of content and data that is required by authorities. Local needs in global context involves local affiliates as an integral part of global processes. Governance of content and data in such environment can no longer be managed by traditional tools. Integral DMS builds the foundation for a new generation RIM (as described by GENS), offering object oriented approach, not only for Document Management, but also for Interfaces with other systems like RIMS, XEVMPD/IDMP, Publishing, ERP/SAP and MDM among others.
It enables management of content and documents in preconfigured granularity in context of product data, which can be exchanged with such systems. Every document and every synchronization object has its regulatory history, allowing impact assessment in local and global context and automation of document creation and processing. In addition, the Integral DMS will reduce the upgrade and validation effort dramatically.
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