REGULATORY DATA HUB
REGULATORY INFORMATION MANAGEMENT
ENTITECH WORKED WITH A TOP 5 PHARMA COMPANY TO PUT IN PLACE A REGULATORY AFFAIRS DATA HUB THAT SATISFIES THE UPCOMING REGULATIONS, AS WELL AS SIMPLIFYING SYSTEM INTEGRATIONS.
The pharmaceutical regulatory data ecosystem has been undergoing some major changes with new data related regulations such as identification of medicinal products (IDMP), pharmaceutical quality/chemistry manufacturing (PQ/CMC), etc. Pharmaceutical companies have traditionally leveraged their regulatory information management (RIM) systems to capture the data needed to support these needs and reporting needs around performance and KPIs. Unfortunately, RIM systems alone rarely meet the demand to meet these needs as a one-stop shop.
At a minimum there is typically data from other systems such as project and portfolio management (PPM) systems, labeling systems, supply chain/manufacturing systems such as enterprise resource planning (ERP), and other smaller applications typically built on business process management (BPM) platforms such as Appian or Pegasystems that require data integration with RIM to work properly.
Entitech Solutions has worked with a Top 5 pharma company to put in place a regulatory data hub that satisfies the upcoming needs for regulations as well as integrations between systems. Our staff worked with regulatory business units to develop a standard set of data publications that would generically satisfy integration needs while removing dependencies on source systems.
Entitech is currently in the process of leading the delivery of the data hub to refactor several point-to-point integrations that were previously put in place. There are also several new system integrations and analytics use cases that are slated for an early 2022 release on the new data platform. Entitech has been instrumental in developing the roadmap and strategy for the upcoming releases.