Submissions Publishing provides an end-to-end publishing process to manage content planning, publishing, and finalizing submissions content in preparation for submitting to Health Authorities. Submissions Publishing includes pre-configured user and system actions to support this process flow. From within Submissions Archive, users can create a collection of documents that represent a change to a product, and submit them for approval to make changes to the marketed product.
Much like Submissions Archive, RIM Submissions Publishing is built on the Vault platform and therefore has some of the features that are described in other Vault Help topics. In addition, RIM Submissions Publishing provides capabilities and configurations specific to managing published submissions content and progressing documents through a review and approval process.
- Link Publishing
- When using Submissions Publishing, customers can create cross-document link annotations within Vault or cross-document links during authoring. When publishing content, Submissions Publishing converts these links to standard relative PDF links.
- Continuous Publishing
- This feature provides the capability to continuously publish documents as they become associated with a content plan and as related content or attributes are updated.
- Continuous Validation
- While users assemble and publish a submission in Vault, Submissions Publishing provides the ability to verify eCTD submissions against the Health Authority validation criteria. This provides validation information on an ongoing basis, allowing users to review and resolve validation errors and warnings.
- Publishing Status Indicator
- A status icon informs users if there are outstanding publishing or validation jobs as part of continuous publishing. This ensures that users only review and submit content after it has been published and validated.
- Document and Object Lifecycle User Actions
- Submissions Publishing includes user actions associated with the Submissions Archive document lifecycle and the Content Plan and Content Plan Item object lifecycles. These actions support the process flow to review and approve documents published through submission content plans.
- Select Leaf Target Operation
- When users create submission content plans using the eCTD structure, Content Plan Item records set to Replace, Append, or Delete must be targeted to the previously submitted leaf node. The Set Leaf Operation standard action allows users to specify a target from a prior submission of the same application.
- Grouped Submissions (US)
- To remove the need to submit multiple, identical submissions to multiple applications, Submissions Publishing provides the ability to group submissions. A grouped submission allows users to submit a single sequence, with one set of files, XMLs, etc. to multiple applications.
- AdPromo Submissions (US)
- When submitting eCTD submissions in the US, organizations include advertisement and promotional material (AdPromo) as part of the US FDA eCTD Module 1. Submissions Publishing provides users with the option to associate documents to the correct Promotional Material nodes from within a US eCTD content plan.
- FDA Gateway Integration (US/CA)
- Sending a submission to the Health Authority through the FDA ESG is the final step of the submission publishing process. FDA Gateway Integration supports the transmission of US eCTD submissions within Vault to the FDA Electronic Submissions Gateway (ESG) to the CDER and CBER divisions, as well as CA eCTD submissions to Health Canada.
- EMA Gateway Integration (EU)
- EMA Gateway Integration supports the transmission of Centralised Procedure eCTD submissions within Vault to the EMA Electronic Submission (ESUB) Gateway directly from a Submission record.
- Submission Administrative Information
- You can view, manage, and update the administrative information associated with a submission during the publishing process.
Supported DTD & Schema Versions
Vault currently supports publishing for the below eCTD DTDs or XSDs and schemas.
Except for Ukraine (UA), Vault also supports validation for the listed eCTD DTDs or XSDs and schemas.
- Australia (AU) 3.1
- Canada (CA) 2.2
- China (CN) 1.0
- European Union (EU) 3.0.1
- Gulf Cooperation Council (GCC) 1.1
- Japan (JP) 1.0
- Jordan (JO) 1.1
- South Africa (ZA) 2.1
- South Korea (KR) 1.0
- Switzerland (CH) 1.4 and 1.5
- Taiwan (TW) 1.0
- Thailand (TH) 1.0
- Ukraine (UA) 1.0
- United States (US) 3.3
RIM Submissions Publishing includes the daily Validation Results Archival job to allow users to reference validation results without cluttering their Vaults with unnecessary records. The job:
- Creates an archive package ZIP file for a submission’s validation results 365 days after the Actual Submission Date
- Adds the archive package as an attachment on the Submission record
- Deletes the archived Submission Validation Results records
Note: Veeva monitors all processing within Vault for malicious content using CrowdStrike (6.37.15103.0) and/or Threat Stack (3.0.6). Any content identified as malicious is removed.