VEEVA RIM Submissions Publishing Overview - By MotivationTech Kitchens

VEEVA RIM Submissions Publishing Overview

Veeva RIM Publishing is a part of Veeva Systems’ suite of tools designed to help life sciences companies manage their regulatory processes. 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.

Veeva RIM Publishing specifically focuses on the creation, management, and submission of regulatory documents to health authorities. The publishing process typically includes:

Document Creation and Preparation: Regulatory teams create and compile documents for submissions, such as New Drug Applications (NDAs), Clinical Trial Applications (CTAs), or Marketing Authorization Applications (MAAs).

Collaboration: Veeva RIM facilitates collaboration among various stakeholders (internal teams, external vendors, regulatory agencies) during the document preparation and review phases.

Automated Publishing: Once the documents are ready for submission, Veeva RIM automates the publishing process, ensuring that documents are formatted and structured according to the specific requirements of each health authority (e.g., FDA, EMA, etc.).

Submission: The platform also enables the direct submission of these regulatory documents to authorities electronically, streamlining the submission process and ensuring compliance with industry standards.

Tracking and Reporting: Veeva RIM provides visibility into submission progress, regulatory milestones, and upcoming deadlines, helping teams stay on track with their submissions.

Veeva RIM Submissions Publishing 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.

By centralizing and automating these tasks, Veeva RIM Publishing helps life sciences companies reduce errors, save time, and accelerate the approval process for new drugs, therapies, or medical devices.

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