The Challenge
The drug safety function is characterized by frequent changes in the Safety System configuration. This is necessitated by the need for harmonizing Global and Japan Business, business restructuring caused by frequent mergers and acquisitions, product divestments, INDs & NDAs, etc.
The ingestion of a continuous stream of business configuration data in safety systems through an expedited and predictable process has been on the industry’s wish list for a long time. The current manual process is not only prone to human errors but also results in additional validation efforts and the engagement of high-value resources in non-value-adding functions.
How it Works
UltraCONFIG automates the Safety System Configuration process across its three modules – Extract, Import, and Compare.
The Extract module, as the name suggests, extracts the configuration from the safety system. This includes Business Configuration, System Configuration, Access Management, Code List, and Flexible Code List. The Import module loads the configuration directly into the safety system. Lastly, the Compare module compares the configurations between any two safety system environments, providing comparison reports between the two environments and comparison reports of the pre- and post-configuration changes.
UltraCONFIG Benefits
UltraCONFIG has delivered certain key benefits, namely:
- Saves time and cost for both new implementations and post-production managed services.
- Optimal utilization of the safety system configuration team.
- Predictable quality due to in-built validations in the tool.
- Repeatable without additional effort.
- Lesser dependency on individual skills and knowledge.
