CASE STUDY

Our data modeling and custom dashboards enabled a global pharma giant to achieve accurate regulatory reporting in serialized product tracking

industry_pharmaceutical

Business Case

 

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.

Our Solution

Our data engineers collaborated with the business users and the SAP consultants to come up with a data model that suited the requirement.  for this, they converted the requirements into use cases and mapped out the data flow through the data model. The resulting reports not only reduced the manual efforts, but also the stakeholders could regularly monitor the data, detect gaps and fix them instantly.

The team created data models for each master data integration requirement and created reports for specific use cases such as Article 57, and EU (European Union) Falsified Medical Directive reporting. They also created interactive business intelligence dashboards for each use case. This helped the stakeholders to create interactive reports backed by data analysis for regulatory reporting. Post the implementation of our solution, the stakeholders could constantly monitor the ECC data, download regulatory reports and report the status overview to the management with ease.

Benefits

  • Requirement specific data modelling helped in creating regulatory specific reports with ease.

  • Stakeholders got a comprehensive view of the ECC data, which made it easier to monitor and detect gaps within the data.

  • The dashboards gave a holistic view of the data and flagged whether a product is serialized or not.

  • The regulatory reporting was now streamlined and hassle-free.

Results