Veeva Vault Registrations

Vault Registrations provides a single global application for planning, tracking and reporting on product registrations and health authority correspondence and commitments. The improved visibility and data quality will streamline registration management and speed responses to health authorities.

Vault Registrations will also support IDMP compliance with an IDMP-based data model, an open integration interface, and the ability to generate IDMP messages.

BENEFITS
  • Improved data quality: Streamline registration management by reducing data duplicates and discrepancies.
  • Global visibility: Stay informed with complete visibility into the marketing status of your global product portfolio.
  • Faster responses to health authorities: Track queries and commitments to stay ahead of response deadlines.
  • IDMP compliance: Prepare for global data standards with an open integration interface and the ability to generate IDMP messages pending final implementation guidelines.

Direct visibility into product registrations around the globe

Interactive dashboards display upcoming commitments

Personalized views of relevant registrations

Features

MANAGE PRODUCT REGISTRATIONS GLOBALLY
Manage all product registration details including formulation specifics, modes of delivery and dosage forms, indications, manufacturing details, and packaging.
EXECUTE IMPACT ANALYSES
Generate reports to identify which registrations are impacted by a potential change, such as manufacturing or label changes.
MANAGE REGULATORY EVENTS
Build a plan for and manage your response to regulatory events by creating the associated activities and assigning responsible parties.
TRACK SUBMISSIONS
Plan, manage, and track the status of submissions and related activities. This includes the data related to initial clinical trial submissions (CTAs, INDs) and initial marketing submissions (NDAs, MAAs).
MANAGE INTERACTIONS AND COMMITMENTS
Retain and classify all correspondence with health authorities. Create commitment records with related tasks and report on progress against outstanding commitments and deliverables.
DASHBOARDS AND REPORTS
Create easy, self-serve reports showing information by any combination of attributes including: product, application, region, manufacturer, and more.
IDMP MESSAGE GENERATION (Future release)
Generate up-to-date IDMP messages based on the latest ISO standards and local implementation guides. Hear a first-hand account of one company’s decision to use Vault Registrations for IDMP, watch video.
APPLICATION INTEGRATION
Leverage the open, published Vault API, to exchange data with other business systems.
ADVANCED DATA MODEL
With IDMP ISO specifications at its foundation, the flexible RIM data model accommodates related elements such as submissions and commitments, as well as the non-linear nature of regulatory information and frequently changing standards.
PART OF THE VEEVA VAULT RIM SUITE
The Vault RIM suite provides complete traceability from source documents to published outputs, and health authority requests and commitments. This end-to-end visibility equips organizations to respond faster to regulatory events or requests for information.

Demos & Videos

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