Regulatory content has traditionally been stored in submissions that are comprised of a variety of component documents. As the industry moves toward standard format of data submissions such as Identification of Medicinal Products (IDMP), Regulatory teams are beginning to look at the data within and about their Regulatory documents.
A wealth of regulatory data exists inside vast R&D document repositories that include product development documentation, regulatory commitments, health authority interactions, and preclinical, clinical, and CMC information. Tracking and managing these critical data elements can be time consuming, resource intensive, and costly. Manual tracking and management can also insert human error into collection and management activities.
The Key Question:
How can Regulatory teams manage the variety, velocity, and volume of critical data stored in a RIM system?
Regulatory teams can master the RIMS data lifecycle by implementing a data governance framework. This approach enables teams to gain consistency across data elements, work with a common understanding of data being referenced, and piece together broader views of global data.
Implementation of a data governance program ensures data accuracy and quality while enabling expanded use for business, technical, and compliance purposes. A data governance program typically addresses:
- How is data used across the organization?
- Who owns the data over the course of the lifecycle?
- Where is the data stored?
- What compliance requirements are relevant?
- What compliance requirements are changing and require an updated approach?
- What policies and practices must be implemented to ensure continued quality of data while supporting business objectives?
As data-driven organizations begin to look past Regulatory submissions, beyond Regulatory documents, and toward Regulatory data, data governance strategies will become increasingly important.
NNIT Life Sciences team has been engaged on numerous RIM projects. We are actively advising clients as they implement a data governance approach within their RIM strategy. Our Regulatory Advisory services combine domain expertise and technology acumen to help clients transform their Regulatory capabilities. Our life sciences team also offers guidance on organizational change management, process definition, technology selection and implementation, and data migration strategies.
Contact us to learn more about our Data Governance Approach to RIMS.