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Veeva Vault RIM

by Veeva Systemsveeva.com
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OVERVIEW

A cloud-based Regulatory Information Management (RIM) solution that unifies regulatory systems and processes for end-to-end submission and registration management.

Veeva Vault RIM is a suite of cloud-based applications built on the Veeva Vault Platform, designed to provide a single, authoritative source for regulatory documents and information globally for life sciences companies. The suite includes four core applications: Vault Registrations (for planning, tracking, and reporting on global product registrations, health authority interactions, and IDMP compliance), Vault Submissions (for content management, planning, authoring, review, and approval of regulatory submissions), Vault Submissions Publishing (for producing compliant published submissions, including eCTD, and accelerating delivery), and Vault Submissions Archive (for secure storage, navigation, and search of submitted regulatory applications).

By unifying content and data on a single platform, Vault RIM eliminates information silos, reduces data duplication, and streamlines cross-functional business processes involving clinical, quality, and safety teams (via Veeva Development Cloud connections). This leads to faster speed to market, stronger compliance, and global alignment of regulatory efforts. The system is GxP and 21 CFR Part 11 compliant, offering robust audit trails, electronic signatures, and automated compliance updates to adapt to evolving global regulatory requirements.

RATING & STATS

User Rating
4.5/5.0
10 reviews
Customers
350+
Founded
2007

KEY FEATURES

  • Unified Regulatory Data Management (Single Source of Truth)
  • Global Product Registrations Management (IDMP compliant)
  • Regulatory Submissions Planning and Tracking
  • eCTD/Non-eCTD Submissions Publishing and Validation
  • Submissions Archive and eCTD Viewer
  • Health Authority Interactions and Commitments Tracking
  • Active Dossier Management
  • Electronic Signatures and Audit Trails

PRICING

Model: enterprise
Veeva Vault applications are licensed on a subscription-based model, typically per module and per named user. Pricing is custom and not publicly disclosed.

TECHNICAL DETAILS

Deployment: saas, cloud
Platforms: web, windows, mac, linux, ios, android
📱 Mobile Apps🔌 API Available

USE CASES

End-to-end Regulatory Information Management (RIM) for Pharma/BiotechStreamlining global regulatory submissions (eCTD/Non-eCTD)Ensuring GxP and global regulatory complianceManaging product registrations and health authority correspondenceConsolidating regulatory data and documents from disparate legacy systems

INTEGRATIONS

Veeva Vault Clinical OperationsVeeva Vault QualityVeeva Vault PromoMats5XIndent

COMPLIANCE & SECURITY

Compliance:
HIPAASOC 2ISO 27001GDPRFDA 21 CFR Part 11EMA EudraLex Volume 4 Annex 11
Security Features:
  • 🔒SSO
  • 🔒2FA
  • 🔒Encryption at Rest and in Transit
  • 🔒Audit Trails
  • 🔒Access Controls
  • 🔒Password Hashing

SUPPORT & IMPLEMENTATION

Support: phone, online support, 24/7 support
Target Company Size: mid-market, enterprise
TRAINING AVAILABLE

PROS & CONS

✓ Pros:
  • +Provides a single, unified cloud platform for all regulatory information
  • +Strong performance in meeting comprehensive regulatory compliance requirements
  • +Excellent Document Tracking and Dossier Management capabilities
  • +User-friendly interface and streamlined workflows (G2 Ease of Use 9.2)
  • +Automated compliance updates and strong product direction
✗ Cons:
  • -Pricing is custom and not transparently published
  • -Administrative tasks may be less straightforward than alternatives
  • -Some users report slow document QC and finalization processes
  • -Customer support response times can sometimes vary

ABOUT VEEVA SYSTEMS

Other software by Veeva Systems:
Veeva MedInquiry (Commercial & Medical AffairsMedical information systems)
Veeva QMS (Procurement & Vendor ManagementSupplier quality management)
Veeva Submissions (Regulatory Affairs & ComplianceSubmission lifecycle tracking)
Veeva Vault PromoMats (Marketing & Commercial OperationsPharma marketing automation (compliant))