References

References support affiliate and regulatory correspondence tracking activities by allowing DMS or file system content to be associated with system entities like product families, applications, events, sequences, and tasks.

References are pointers to external sources of information, such as documents or external URLs. They may also be used to associate internal URLs with major entities.

You can create references for any of the following entities:

• Product families
• Products
• Pharmaceutical Products
• Manufactured Items
• Projects
• Applications
• Events
• Sequences
• Registrations
• Medicinal Products
• Medicinal Product Action
• Tasks
• Submission Plans
• Change
• Change Details

References also support correspondence other than official regulatory content sent to the regulatory agency (for example, sequences). References can include telephone communication, dispatches of information to affiliates, or approval letters received from the authority.

References are specific to the following Ennov InSight modules:

• Registration Planning and Tracking
• Submission Planning and Tracking