• No transparency and insight into the data to be coordinated and processed by the IT systems used in Medical Affairs.
• No overview of the IT landscape and the interaction of individual IT systems and their data.

Based on existing IT system documentation and interviews with responsible IT system managers, the following result types were produced:

• Graphical overview of the established IT architecture.
• Entity relationship model with the essential data objects/data attributes per IT system.
• Classification and cross-IT system determination of references to data objects/data attributes.
• Definition of information domains and their connections to each other (Business View).
• Handover and explanation of practical examples of how such documentation can be used.

A systematic and comprehensive data model documentation including application examples, that answers the following questeions:

• What must be considered in the case of replacing an IT system?
• What information is necessary to make decisions for changing the IT architecture?
• Where is the origin/source of certain data? What is the data-carrying system?
• What data is held in which IT system?
• Is computer system validation required?