A global pharmaceutical company was facing data management challenges for regulatory reporting with their serialization product tracking (SPT) department. The SPT team was using SAP Central Component (ECC) to store master meta data such as location, batches, doses, etc. This data was critical for regulatory reporting and needed efficient and regular monitoring.
The regulatory and compliance team must acquire information from the ECC system for regulatory reports submission pertaining to Article 57 and Falsified Medical Directive reporting. However, with the current setup, the SAP reports were not available, and integrating data manually was time consuming owing to the vast volume of data within the ECC system.
The company was looking to streamline the ECC data management and regulatory reporting which will enable the team to monitor the data and produce accurate reports.