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.