White paper

Achieving Regulatory Operational Excellence:
Unified Quality and Regulatory Information Management

An effective, efficient and comprehensive approach to managing Quality and Regulatory information is an important element in achieving Regulatory operational excellence.

Ennov’s white paper examines the variation submission process – a high volume and high frequency Regulatory activity that is critical to maintaining marketing authorizations and the complex system and data dependencies required to support it.

Topics discussed include:

• Department roles and responsibilities
• Systems involved in managing the process
• System interactions and data dependencies
• System interfaces and integrations
• The benefits of a unified platform