Vault 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, Vault 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.
Vault Registrations is part of the Vault RIM family of applications. 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.
Vault 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: Vault 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, Vault 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 Vault RIM 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: Vault 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: Vault Registrations can aggregate product data and validate that data complies with XEVMPD validation rules before submission to the EMA through the EMA Gateway. Additionally, Vault 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: Vault 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.
Quality to RIM Vault Connection: Change Control & Variation Management
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 to RIM Vault Connection.
- Bulk Creating Activities, Submissions & Regulatory Objectives
- Configuration for Bulk Creating Activities, Submissions & Regulatory Objectives
- Bulk Creating Product Registrations
- Bulk Creating Investigational Registrations
- Bulk Creating Active Substance Registrations
- Bulk Creating Manufacturing Site Registrations
- Configuration for Bulk Creating Registrations
- Managing Registered Details
- Configuring Manage Registered Details
- Configuring Object Type Mapping for Registrations
- Generating the Registration History Report
- Registration History Report Configuration
- Impact Assessment Reports
- Setting Up Standard Impact Assessment Reports
- Setting Up Configurable Impact Assessment Reports
- Bundling Submissions & Regulatory Objectives
- Splitting Regulatory Objectives
- Configuring Bundling & Splitting
- Generating IDMP Data
- XEVMPD Data Review & Validation
- XEVMPD Gateway Submission
- XEVMPD Bulk Update & Submission
- XEVMPD Configuration
- Using the Affiliate Home Tab
- Affiliate Home Tab Configurations
- Quality to RIM Vault Connection for Change Control & Variation Management
- Configuring the Quality to RIM Vault Connection for Change Control & Variation Management
- Pausing Vault Java SDK Record Triggers in RIM Registrations
- About the EMA RMS Integration