# Veeva Submissions Publishing Overview 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. ## Submissions Publishing Features {#features} 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. Document Reuse : Vault automatically identifies documents within eCTD 4.0 submissions that have previously been submitted within the same Lead Market, Health Authority, and Health Authority division. : This setting can be disabled on a Content Plan Item level to prevent Vault from reusing the document. : When publishing Vault considers all imported submissions with Actual Submission Date and published submissions the lifecycle state of Health Authority Received as _submitted_ submissions to be in scope for document reuse. Set Document Update Operation : You can select a previously submitted document within the application and update that document's _Title_. Vault sets the _eCTD 4 Modified Files_ field to the ID of the previously submitted document and the _Node Type_ to _Document Metadata Update_. When publishing Vault considers all submissions with Actual Submission Date and the lifecycle state of Health Authority Received as _submitted_ submissions to perform Document Metadata Updates against. Priority Number Generation and Updates : You can set and define the order of a Context of Use (CoU) within eCTD 4.0 submissions. The **Update Priority Numbers** dialog allows users to update the priority order (*Priority Number*) of a Content Plan Item, thereby changing the order of the documents displayed in the Submissions Archive Viewer. When publishing Vault considers all submissions with Actual Submission Date and the lifecycle state of Health Authority Received as _submitted_ submissions in order to set priority numbers across context of use in the context group. : Vault automatically sets the priority number of a Context of Use within a Context Group at the time of publishing. Vault does not set a Priority Number on a CoU if the Context Group contains more than 999999 Context of Use elements. Sender Defined Keywords : eCTD 4.0 Sender Defined Keywords (`ich_keyword_type_1` to `ich_keyword_type_14`) are generated in the submissionunit.xml based on values from relevant Submission relationship fields. When publishing Vault considers all submissions with Actual Submission Date and the lifecycle state of Health Authority Received as _submitted_ submissions in order to capture sender defined keywords on the _Application eCTD Keywords_ object. Contact Details : When required, the _Submission Contact_ object (`submission_contact__v`) should be included on a _Submission_ record. In order for the contact details to be reflected on the Submission Unit XML on an eCTD 4.0 submission, ensure the _Status at Health Authority_ field (`status_at_health_authority__v`) is populated to correctly reflect the _Submission Contact_'s lifecycle state. Refer to regional guidelines for lifecycle guidance. ## Supported Versions for Publishing Vault currently supports the below eCTD and non-eCTD DTDs and schemas. Publishing that uses an unsupported version will fail. ### Supported DTD & Schema Versions for ICH 3.0 & 3.2 Vault currently supports publishing and validation for the below eCTD DTDs or XSDs and schemas for ICH 3.0 and 3.2. * Australia (AU) 3.1, 3.2 * Bosnia (BA) 1.0 * Canada (CA) 2.2 * China (CN) 1.0,1.1 * Eurasian Economic Union (EAEU) 1.1.0 * European Union (EU) 3.0.1, 3.0.4, 3.1, 3.2 * Gulf Cooperation Council (GCC) 1.1 * Japan (JP) 1.0 * Jordan (JO) 1.1 * Singapore (SG) 1.0, 1.1 * South Africa (ZA) 2.1, 3.0, 3.1, 3.2 * South Korea (KR) 1.0 * Switzerland (CH) 1.4, 1.5 * Taiwan (TW) 1.0, 2.0 * Thailand (TH) 1.0 * Tunisia (TN) 1.1 * Ukraine (UA) 1.2 * United States (US) 3.3 * World Health Organization (WHO) 1.1 ### Supported Versions for ICH eCTD 4.0 Publishing Vault currently supports the following eCTD DTDs and schemas for ICH 4.0: * Japan (JP) 1.6, 1.6.2 * United States (US) 1.8 ### Supported Versions for non-eCTD Publishing Vault currently supports publishing for the below non-eCTD DTDs or XSDs and schemas: * Eurasian Economic Union (EAEU) 1.1.0 Vault provides a set of standard Non-eCTD validation for non-eCTD regions. Vault also supports validation for the listed non-eCTD Regions. * Bosnia (BA) 1.0 * Health Canada (HC) NeeS v5.2, v5.3 ## Standard Jobs 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: * Is set to **Active** on all RIM Vaults * Creates an archive package ZIP file for a submission's validation results 90 days after the _Actual Submission Date_ * Adds the archive package as an attachment on the _Submission_ record * Deletes the archived _Submission Validation Results_ records