A holistic Next Generation RIM design model champions major synergies compared to the traditional table-oriented. Once in the system, all entities can be versioned and life cycled, allowing full record track. Master data can be used as meta data in multiple modules of an integral application. Such product information, centric-approach allows a seamless transition to a higher granularity and consistency of information, from planning and tracking, towards IDMP, including Master Data Management, content creation and maintenance automations. Precondition for such holistic approach is a combination of Product Master Data and Regulatory Intelligence capabilities, building the foundation for automation of all regulatory processes including configurable interactions with other systems, allowing efficient and right-first-time data management to the utmost possible extent. As there is a direct correlation between realized value, compliance and complexity, reduction of complexity translates into the reduction of TCO’s driven by magnitude wide reduction of hidden costs, which are rarely measured. Under hidden costs, we understand: - Not realized productivity due to complexity of systems, processes, organizations and products - Challenges in reflecting global versus local requirements - Missed process performance improvement, due to complex interfaces - Quantification of compliance risks - Backlog of projects (IT and business) Complexity is the main exponential cost driver in R&D IT and it is the major compliance risk. Reduction of complexity contributes to higher compliance and reduces costs. Integral approach can change the paradigm of compliance being cost of doing business and create value from compliance. Elements of compliance value: - Consistency between data and content - Process automation - Faster product to market - Lower product maintenance effort - R&D IT can focus on innovation versus on supporting legacy

Turn Compliance into Value – Decrease Complexity, Increase Compliance and Reduce Total Costs of Ownership

DIA Europe 2019

A global, member-driven non-profit organization mobilizing life sciences and healthcare. DIA fosters innovation to improve health and well-being worldwide. Professionals from 80 countries continue to engage with DIA through our unparalleled membership network, educational offerings, and professional development opportunities.