# RIM Registrations Overview

Veeva RIM Registrations is an end-to-end application for planning, tracking, and reporting of product and registration information, management of Health Authority interactions, and generation of product data messages.

As a global solution, Registrations provides a single authoritative information source for all product and regulatory information relevant to global registrations. In particular, it supports the management of manufacturing and labeling-related change events, as well as the associated activities in response to those events. This includes varied and detailed information on the medicinal product, such as specifics on the packaging, dosage forms, indications, and manufacturing details.

Registrations is part of the [Veeva RIM family of applications](/en/lr/30696/).
 Within a single Vault, your organization can have one, two, or all of these applications. These applications share a common data model, but each provides additional pieces of functionality to help manage global regulatory processes.

## Registrations Features

Registrations is built on the Vault platform and includes the features described in the platform help topics. In addition, it includes these capabilities and configurations specific to managing product and device information:

  * **Advanced data model**: Registrations is built upon a strong foundational data model based on industry data management best practices as well as the ISO IDMP and IMDRF UDI standards to account for the non-linear, relational nature of product and regulatory information. Vault's data model also includes handling of commitments, correspondence, and Health Authority questions and answers. The data model is easily extensible to manage customer-defined data tracking requirements.
  * **Manage regulatory events**: Registrations provides the ability to capture, manage, and track regulatory events (regulatory approval, manufacturing changes, label changes, etc.), quickly assess the impact of planned changes, and take action. Vault provides bulk data creation functionality tailored specifically for RIM Registrations, which allows efficient creation of submissions, activities, and regulatory objectives for each event or impact assessment report. Within each event, centralized teams can plan and track local market submissions and distribute to the local market product owners as appropriate. For markets that support multiple changes in one submission, or limits to the number of changes allowed during a specific timeframe, Registrations can bundle changes together based on user selection.
  * **Manage label changes and deviations**: When regulatory events and activities have labeling impact, Label Concept and Deviation Tracking in Registrations allows for detailed tracking and management of the resulting labeling concept updates and deviations. Organizations enter proposed changes and send them to affiliate teams to provide local disposition and capture deviations in local labeling; Vault makes the changes and timelines globally and locally visible while the label content is approved, updated, and submitted.
  * **Manage the lifecycle of detailed product information**: Organizations can capture, manage, and track details related to the lifecycle of products and their associated registrations. This functionality includes the ability to generate full registered detail data from the initial application and update registered details across multiple licenses based on approval of a proposed change from a Health Authority. This ensures that all data is up-to-date and accurate for reporting.
  * **Execute impact analysis of change**: Reporting functionality allows users to execute a report detailing the impacts of potential change to existing registrations, including regional and local details.
  * **Generate a history of registration data**: Users can generate a historic view of registration data to support regulatory requirements. With this report, users can view a history of all registration changes globally or generate Pharmacovigilance Master File (PSMF) appendices.
  * **Provide an affiliate-specific user interface**: Registrations provides a specific UI for each country-level user that presents their open change activities, regulatory objectives, and their current approved licenses in an easy to navigate dashboard view. Affiliate users who are likely to be less frequent users can quickly update their local tasks to better support global visibility.
  * **Create & track Health Authority interactions**: Users can record interactions (including correspondence) with Health Authorities and classify these according to various criteria like region and HA.
  * **Plan & create commitment records**: Users can plan, create, and track required deliverables, including Annual Reports, Renewals, PADER, RMP/REMS, PVMF, PSUR, DSUR, CER. Furthermore, users can create commitment records based on correspondence received from Health Authorities and report on the progress against outstanding commitments.
  * **MedDRA Dictionary Loader**: MedDRA indication terminology (Lower Level Terms/LLTs, and their associated Preferred Terms/PTs) can be imported into Vault as _Coded Indication_ object records. Users access the tool via the **RIM Maintenance** tab and import dictionary data at their discretion, using their MedDRA credentials. Similarly, when a new dictionary is released, users can perform a sequential update to update the terms in their _Coded Indication_ object records.
  * **XEVMPD Data Management**: Registrations can aggregate product data and validate that data complies with XEVMPD validation rules before submission to the EMA through the EMA Gateway. Additionally, Registrations supports bulk updates to XEVMPD and bulk gateway submission in order to facilitate changes that may impact a large number of EV Codes.
  * **IDMP Data Management**: Registrations can aggregate Identification of Medicinal Products (IDMP) data, offering a simple way to compile product data before submitting it to the European Medicines Agency (EMA).

## Automated Object Record Creation

In RIM Registrations, Vault automatically creates or updates certain object records when users create related records to speed the data entry process and increase information accuracy.

### Country Decision Detail Records

Vault creates _Country Decision Detail_ records automatically when users create _Regulatory Objective_ records:

  * Vault creates one record for each _Country_ associated to the _Application_ that is referenced by the _Regulatory Objective_ record. This includes both the _Lead Market_ field and the _Application Country_ relationship.
  * Vault creates one record per country.
  * Vault updates the _Country Decision Detail Count_ field on the _Regulatory Objective_ record at the end of record creation to capture the number of records created automatically. Vault also updates this field each time users delete related _Country Decision Detail_ records. This allows Admins to configure lifecycle logic that automatically promotes the _Country Decision Detail_ status for single-market _Countries_ based on the _Count_ field.

Vault will not create _Country Decision Detail_ records for existing _Regulatory Objective_ records. We recommend manually creating these records for any _Regulatory Objectives_ that are currently in progress in your Vault.

Admins can create additional fields on the _Country Decision Details_ object but should not make these fields mandatory for users creating new records. Mandatory fields will cause Vault to skip creating new _Country Decision Details_ records when users create _Regulatory Objective_ records.

### Administered Product Records

When users create _Administered Product_ object records of object type _Administered as Manufactured_, Vault automatically copies over active and inactive ingredient data from related _Product Variant_ (`product_detail__v`) records to the new _Administered Product_ records.

Vault copies relationships and maps fields based on the object record users select in the _Reference Product Detail_ field on the new _Administered Product_ record:

  * Vault adds data from the related _Product Variant Active Substance_ record to the _Administered Product Active Substance_ record.
  * Vault adds data from the related _Product Variant Inactive Ingredient_ record to the _Administered Product Inactive Ingredient_ record.

Vault does not update data for _Administered Product_ object records of object type _Mixed or Modified After Manufacturing_. If you have required fields configured on the target objects, Vault will not be able to create the records.

## Standard Connections

### Quality-RIM Connection

This Vault Connection between a Quality QMS Vault and a RIM Registrations Vault automates data sharing between the two applications, supporting change control initiation, regulatory assessment, and close out. See details about the [Quality-RIM Connection](/en/lr/57086/).

## Related Articles

  * [Bulk Creating Activities, Submissions & Regulatory Objectives](/en/lr/53688/)
  * [Configuration for Bulk Creating Activities, Submissions & Regulatory Objectives](/en/lr/59835/)
  * [Bulk Creating Product Registrations](/en/lr/43102/)
  * [Bulk Creating Investigational Registrations](/en/lr/45395/)
  * [Bulk Creating Active Substance Registrations](/en/lr/65511/)
  * [Bulk Creating Manufacturing Site Registrations](/en/lr/65523/)
  * [Configuration for Bulk Creating Registrations](/en/lr/57203/)
  * [Managing Registered Details](/en/lr/43108/)
  * [Configuring Manage Registered Details](/en/lr/60452/)
  * [Configuring Object Type Mapping for Registrations](/en/lr/62601/)
  * [Generating the Registration History Report](/en/lr/61211/)
  * [Registration History Report Configuration](/en/lr/61209/)
  * [Impact Assessment Reports](/en/lr/43119/)
  * [Setting Up Standard Impact Assessment Reports](/en/lr/61001/)
  * [Setting Up Configurable Impact Assessment Reports](/en/lr/63976/)
  * [Bundling Submissions & Regulatory Objectives](/en/lr/49520/)
  * [Splitting Regulatory Objectives](/en/lr/50022/)
  * [Configuring Bundling & Splitting](/en/lr/50545/)
  * [Generating IDMP Data](/en/lr/64159/)
  * [XEVMPD Data Review & Validation](/en/lr/50940/)
  * [XEVMPD Gateway Submission](/en/lr/57152/)
  * [XEVMPD Bulk Update & Submission](/en/lr/60423/)
  * [XEVMPD Configuration](/en/lr/58680/)
  * [Using the Affiliate Home Tab](/en/lr/53864/)
  * [Affiliate Home Tab Configurations](/en/lr/54906/)
  * [About the Quality-RIM Connection](/en/lr/57086/)
  * [Configuring the Quality-RIM Connection](/en/lr/57247/)
  * [Pausing Vault Java SDK Record Triggers in RIM Registrations](/en/lr/64586/)
  * [About the EMA RMS Integration](/en/lr/67449/)