The IDMP Accelerators and Worksharing Improvements features, available in 21R1, include asynchronous data mapping activities in Vault. Users need to ensure that their existing data is in order before data mapping occurs.
Data Mapping Overview
With the 21R1 release, Vault will automatically:
- Map existing Application values on Regulatory Objective records to new Application Regulatory Objective join records
- Map existing Shelf Life values on Registered Packaging records to new Registered Shelf Life and Storage records
- Map existing Manufacturing Site Role values on Registered Packaging, Registered Product, Registered Active Substance, and Registered Inactive Ingredient records to new Registered Site Role records
Application Regulatory Objective Mapping
The Application Regulatory Objective object, introduced in 21R1, supports cross-application regulatory objectives, such as EU worksharing and US grouping. Mapping data to this object will facilitate better reporting from a single place in Vault. With the 21R1 release, Vault will create one (1) new Application Regulatory Objective record for every Application referenced by an existing Regulatory Objective record.
After the release, when a user creates a new Regulatory Objective record with the Application field populated, Vault creates one (1) related Application Regulatory Objective record for each unique combination of Application and Regulatory Objective. If a user changes the Application value on a Regulatory Objective record, Vault will automatically update the related Application Regulatory Objective record.
Configuration Steps
There is no configuration required to support data mapping. If desired, you can add a related object section for the Application Regulatory Objective object to the Regulatory Objective object page layout. This will allow users to see the Application Regulatory Objective records Vault creates.
Registered Shelf Life & Storage Mapping
The Registered Shelf Life and Storage object was introduced in the 20R3 release. With the 21R1 release, Vault will create one (1) new Registered Shelf Life and Storage record for each unique combination of Packaging and Shelf Life on existing Registered Packaging records. Vault will not delete any existing Registered Shelf Life and Storage records. Vault copies values in the Registration, Packaging, Shelf Life, Product, and Product Variant fields to the new records.
During data mapping, Vault will ignore any reference constraints on Registered Shelf Life and Storage record fields. You will need to verify and validate this data. The data mapping is designed to be a starting point for data review.
Note: If you do not want mapping to occur in your Vault for the Registered Shelf Life and Storage object, add a custom required field or set the Packaged Product and Device object types to inactive on this object. This will prevent data mapping in your Vault when the 21R1 release occurs. This may be relevant for organizations with Vaults that are undergoing a migration effort or in Vaults that already have data in this object.
Configuration Steps
Before data mapping occurs, we recommend the following:
- Add an object lifecycle for the Registered Shelf Life and Storage object. You should ensure that the starting state is appropriate for your organization’s needs, as Vault will create new Registered Shelf Life and Storage records in this state.
- If you configured the Registered Shelf Life and Storage object after the 20R3 release, ensure that you have not added custom required fields or made any standard fields required on any object types. These will cause data mapping to fail.
- Configure system-managed naming on the Registered Shelf Life and Storage object. Include a sequence number counter in your naming pattern to ensure that record names are unique.
- Ensure the Packaged Product and Device object types are active on the Registered Shelf Life and Storage object. Vault will not map data for inactive object types.
Registered Site Role Mapping
The Manufacturing Site Role field and the Registered Site Role object were introduced in the 20R3 release. With the 21R1 release, Vault will create one (1) new Registered Site Role record for each unique combination of Finished Product Manufacturer and Manufacturing Site Role on existing Registered Packaging, Registered Product, Registered Active Substance, and Registered Inactive Ingredient records. Vault copies values in the Registration, Finished Product Manufacturer, Manufacturing Site Role, and Regulatory Objective fields to the new records.
During data mapping, Vault will ignore any reference constraints on Registered Site Role record fields. You will need to verify and validate this data. The data mapping is designed to be a starting point for data review.
Note: If you do not want mapping to occur in your Vault for the Registered Site Role object, add a custom required field or an object type to this object. This will prevent data mapping in your Vault when the 21R1 release occurs. This may be relevant for organizations with Vaults that are undergoing a migration effort or in Vaults that already have data in this object.
Configuration Steps
Before data mapping occurs, we recommend the following:
- Add an object lifecycle for the Registered Site Role object. You should ensure that the starting state is appropriate for your organization’s needs, as Vault will create new Registered Shelf Life and Storage records in this state.
- If you configured the Registered Site Role object after the 20R3 release, ensure that you have not added custom required fields. These will cause data mapping to fail.
- Configure system-managed naming on the Registered Site Role object. Include a sequence number counter in your naming pattern to ensure that record names are unique.
- Ensure that object types are not enabled on the Registered Site Role object. Enabling object types on this object will cause data mapping to fail.
- If desired, you can add a related object section for the Registered Site Role object to the Registration object page layout. This will allow users to see the Registered Site Role records Vault creates.