Migrating Data to Veeva Submissions Archive

A Veeva Submissions Archive migration involves object data, correspondence source documents, receipts, and acknowledgements (where applicable). This guide covers the most common aspects of migrating data into a Submissions Archive Vault.

Migrating Object Data

For Veeva Submissions Archive, there are certain core RIM objects used by the application which are typically populated either manually or through migration. The key objects to address are Application and Submissions objects.

Thereafter, the following object data should be considered as it enables filtering capabilities on the Submissions Archive Viewer, helping users find specific content faster:

Application Country
Product Family
Regulatory Objective (When this is populated on correspondence documents, this enables the Filter Correspondence by Regulatory Objective feature)
From the Submission column in the “Archive Metadata” column grouping:
- Submission Active Substance
- Submission Clinical Study
- Submission Country
- Submission Inactive Ingredient
- Submission Indication
- Submission Language
- Submission Nonclinical Study
- Submission Product
- Submission Site Role (Relates Submission and Manufacturer)
- Submission Pharmaceutical Form
- Submission Packaging
- Administered Product
- Submission Nomenclature Code

In addition, when migrating to Veeva Submissions Archive you may consider the following:

Gateway Receipts: migrated as attachments to the Submission record
Acknowledgements: migrated as attachments to the Submission record
Correspondence (Source Documents): migrated to the Vault Library to the Regulatory > Correspondence classifications. Correspondence source documents appear in a “Correspondence” section in the Submissions Archive Viewer via the Show Correspondence in Viewer feature.

Considerations

The same considerations as with Submissions apply to Submissions Archive.

For Submission object records, ensure that the Dossier Format is populated. Dossier Format is a type of Veeva RIM Controlled Vocabulary, that facilitates constructing the Source File Path visible in Submissions Archive Viewer.

For example, the Dossier Format: eCTD has a parameter: {application__v.folder_name__v}/{submission__v.xml_submission_id__v}

When eCTD is specified on the Submission record and a submission is imported to Veeva Submissions Archive, Vault uses the Application Folder Name on the parent Application record and the Sequence ID from the parent Submission record to build the first and second level folders of the content in Submissions Archive Viewer.

Ensure that all Submission records have an Actual Submission Date that is not a date in the future. The Submissions Archive import cannot proceed if the Actual Submission Date is a future date respective to the date the import is occurring.

Migration Sequence

Object migration is required prior to any Veeva Submissions Archive data migration, as the application requires Application and Submission records to be able to import a sequence.

Post-Import Errors & Warnings

Veeva Submissions Archive compiles information about each import into a Vault notification sent to the import-initiating user. The content in this Vault notification is concurrently added to the parent Submission record as a record attachment file named Submissions Archive Import Results-{UUID}.csv, where {UUID} is a unique identifier string generated by Vault.

Review the informational and warning messages in the email notification and the import results CSV to determine if corrective action is required. Learn more about errors, limits, and warnings when importing Submissions.

Cutover Strategy

Consider if there will be a blackout period of the source system, where no further Veeva Submissions Archive content will be loaded to the source. You should determine a plan for migrating any differences between the source and target system.

Import Submissions Archive

Import the initial Submission for each Application first. Import by Actual Submission Date, from oldest to newest.

When importing Japanese eCTD submissions, submissions must be imported sequentially.