With the Registration History Report, users can generate a view of registration-related audit trail data to support regulatory requirements. To generate the report, Vault gathers information from the audit trail across Registration and registered detail records in a Microsoft Excel️ file. The Registration History Report allows users to view a history of all registration changes globally or generate Pharmacovigilance Master File (PSMF) appendices.
Note: This feature is only available on RIM Registrations Vaults.
Enabling the Registration History Report
Navigate to Admin > Settings > Application Settings and select the Configure Registration History Report checkbox to enable the report. After you select this checkbox, use the drop-downs below it to select the fields on the Regulatory Objective, Registration, and related registered details objects that you wish to include in the report. Vault includes the fields that you select as report columns, grouped by object.
When selecting fields related to the registered details, Vault will only show fields with a shared internal name.
Configuration for the Registration History Report
To enable users to generate the Registration History Report, add the Application: RIM Registrations: Bulk Registration History Report permission to necessary security profiles.
You can also allow users to generate the report for a single Registration record by configuring atomic security on the Registration History Report action. You can enable this action for specific Registration object lifecycle states or make it available in all lifecycle states.