Updating Local Regulatory Information

By default, the Create Related Records wizard allows users to bulk create local regulatory information (Activities, Submissions, Regulatory Objectives) across many markets from a given Event record. For situations where an Event’s scope later increases or decreases, the Update Local Regulatory Information wizard allows users to quickly push the new or updated details in bulk to these existing local records. This capability is useful when, for example:

  • A new Packaging and its related details (such as Shelf Life or Condition) are added to an Event with existing Submissions and Regulatory Objectives for many markets.
  • A Change Item requires a new Labeling Concept, and that Change Item is already related to a number of Activities.
  • Event details are required for content planning in RIM Submissions.

How Vault Updates Local Regulatory Information

When users bulk create local regulatory information with the Create Related Records wizard, Vault references a related Application Setting to prepare the Event and its relationships for eventual use within the Update Local Regulatory Information wizard. Then, when an event’s scope changes and users run the Event’s Update Local Regulatory Information action, Vault references these fields to automatically determine in-scope Event relationship records to potentially copy to the local related Activity, Submission, and/or Regulatory Objectives.

To qualify for use within the wizard:

  • The Event record must have at least one active related Activity, Submission, or Regulatory Objective, as well as a Local Regulatory Info Last Created field value.
  • The Event’s relationship records must have a Last Sent to Impacted Markets field value which is more recent than the Event’s Local Regulatory Info Last Created value.

Then, Update Local Regulatory Information wizard users review and confirm this pre-selected list of available Event relationship records Vault will copy once they click the wizard’s Finish button:

  • When a record is pre-selected and the user de-selects it, Vault does not copy that record.
  • When a record is not selected and the user selects it, Vault copies that record, as long as it passes various validation checks. These validation checks are the same as those Vault runs for the Create Related Records wizard.
  • Pre-selected records are still subject to the wizard’s validation checks. Vault logs all validation errors in the wizard’s CSV results file.

When evaluating records to copy, Vault may additionally exclude local records in certain lifecycle states. When a target Activity, Submission, and/or Regulatory Objective record’s lifecycle state is selected within an optional sub-setting, Vault does not copy Event relationships to that local record.

Updating Local Regulatory Information

To copy Event relationship records to existing Activity, Submission, and/or Regulatory Objective records:

  1. Open the associated Event record from Business Admin or a custom tab.
  2. Select Update Local Regulatory Information from the record’s All Actions menu. The action may only be available in certain lifecycle states, depending on your Vault’s configuration.
  3. On the Select Relationships page, review the list of available Event relationships to copy. By default, Vault detects relationships that have not yet been copied and pre-selects them for you. Select or de-select relationships as required, then click Next.
  4. On the Define Relationships page, review the list of available Event relationship records to copy. By default, Vault detects records that have not yet been copied and pre-selects them for you. Select or de-select records as required, then click Next.
  5. On the Confirmation page, review the summary of records Vault will create based on your selections. Click Back to re-define and/or re-select relationships, or click Cancel to discard all selections and return to the Event record.
  6. Click Finish to begin creating records.

When you select Finish, Vault begins creating records according to your selections. Once complete, you’ll receive an email and Vault notification with a CSV file confirming the records Vault created or updated.

Limitations

The Update Local Regulatory Information wizard is intended to copy existing Event relationship records to existing Activities, Submissions, and/or Regulatory Objectives only; the wizard does not allow users to create new Event relationships. Similarly, when an Event relationship record is updated, the wizard does not push out those edits to any Activity, Submission, and/or Regulatory Objective relationship records which were created from that Event relationship. To add, replace, or withdraw Event details, use the Create & Manage Event Details wizard.

Vault cannot detect duplicate records when the Activity, Submission, and/or Regulatory Objective relationship object fields are configured with a default value. Contact your Vault Admin if the Update Local Regulatory Information wizard creates duplicate Event relationship records.

See Configuration for Updating Local Regulatory Information for the permissions required to use this feature.