Description: An increasing challenge is to manage change events and their impacts across multiple systems: QMS, RIM, document management, publishing, submission management and/or structured data submission (such as IDMP or EUDAMED). In addition to the operational needs, regulatory systems must manage data consistency and offer reliable global reporting. We will examine the most common approaches: (a) Building interfaces or integrations between distinct specialized systems, or (b) using a single global system. We will compare approaches using the example of an end-to-end process to handle a manufacturing change and its regulatory impacts for Pharma or Device products.
Learning Objectives:
Provide a high level overview of interactions between systems required for regulatory submissions
Assessing the complexity of system integration
Raise awareness about global end-to-end process efficiency
