Terminology Consistency is the Key to Better Regulatory and Manufacturing Information Throughput and Connections
By Steve Gens
There are growing efforts to improve the connection between regulatory information management (RIM) systems and enterprise resource management (ERP) solutions used for product change control and supply release. We know that improving data management and connections to other functional areas (clinical, safety/PV etc.) is a priority for companies.
As I stated in the our 2018 World Class RIM study of 69 companies, the RIM/ERP connection is expected to grow to 40% from 11% in two years. The issue is that often this is seen as a RIM/ERP integration project, whereas the transformation really needs to be about harmonising the terminology used by regulatory and manufacturing. That’s the more complex job but it’s what is needed to share information more easily.
Once companies do implement terminology consistency, some valuable automation capabilities become possible. Examples of where automation can streamline the process include:
- Once regulatory approval has been received, the RIM capability triggers a product release for marketed products
- A registration change to “not approved by the health authority” in the RIM system halts product batch release
- On regulatory approval, RIM capabilities trigger product release for clinical development
- The RIM registration system is used to determine product recalls for specific markets
- A registration expiration in the RIM system halts product planned batch runs or release
A growing number of companies either have these capabilities, have these as a funded objective, or are exploring the possibility. While these are small wins, they all add up to a lot of manual processes. Each of these processes requires people to collaborate across regulatory and manufacturing or supply release, which is an issue in a large company or a company with a diverse product portfolio.
Automating this connection will increase information throughput leading to reduced cycle times, increased productivity, and the potential for cost savings.. All these capabilities come down to continuous improvement and making processes more productive and efficient while increasing compliance across the portfolio.
