Document Management needs to be part of a holistic Regulatory and Quality Information Management solution, supporting Marketing Authorizations and orchestrated by easy to apply Change Controls on any level. This should enable risk-based validation of the system. The demands for greater granularity of content and data are being required by the authorities. The segmentation between Document Management and Publishing has been disappearing.
A new demand for global context requires the direct involvement of local affiliates as an integral part of these critical global processes while not losing the requirements for local needs. Governance of content and data in such an environment needs to be re-thought to eliminate the requirements for manual interventions. When the DMS is built with a new "integral" architecture, it is conceptually part of the next generation RIM (as described by GENS & Associates), reusing master regulatory and quality data not only for Document Management, but also for other modules like RIMS, XEVMPD/IDMP, Publishing, ERP and others. The new architecture enables the management of all related content in context with product data, which will then be shared with each solution module. Every document and every related data object has its regulatory history, allowing impact assessment in both a local and global context. This allows for optimal automation of document creation and processing. A DMS architecture in this new "integral" design will dramatically reduce the upgrade and validation effort.