Veeva QMS logo

Veeva QMS

by Veeva Systemsveeva.com
VISIT OFFICIAL WEBSITE →

OVERVIEW

A cloud-based quality management system (QMS) on the Veeva Vault platform, designed to unify and streamline quality processes for life sciences and medtech companies.

Veeva QMS is a cloud-based Quality Management System built on the Veeva Vault platform, specifically tailored for the highly regulated life sciences and medtech industries. It provides a unified, global solution to manage all quality processes across an organization and its external partners (suppliers, contract manufacturers, labs).

The system delivers a faster time-to-value by offering built-in best practices and automated workflows for core quality processes. Key capabilities include managing Non-conformances, Deviations, Corrective and Preventive Actions (CAPA), Internal and External Audits, Complaints, Quality Risk Management (QRM), Supplier Quality Management, and Change Control.

Veeva QMS ensures greater compliance with regulations like FDA 21 CFR Part 11 and EU Annex 11 by providing robust, compliant audit trails and connecting quality processes with critical documentation (via integration with Veeva QualityDocs). The open Vault API facilitates integration with other enterprise systems like ERP, LIMS, MES, and CRM, creating a single source of truth for quality data. It is designed for enterprise-level organizations, offering a modern, easy-to-use web interface accessible on any device.

RATING & STATS

User Rating
4.1/5.0
51 reviews
Customers
300+
Founded
2007

KEY FEATURES

  • CAPA Management
  • Deviation and Non-conformance Management
  • Internal and External Audit Management
  • Quality Risk Management (QRM)
  • Supplier Quality Management
  • Change Control
  • GxP Compliant Audit Trails
  • Automated Workflows and Quality Lifecycles
  • External Partner Collaboration

PRICING

Model: enterprise
Subscription-based enterprise licensing. Pricing is not publicly disclosed and is customized based on the number of users, specific Vault modules deployed (e.g., QMS, QualityDocs), and overall enterprise agreement.

TECHNICAL DETAILS

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

USE CASES

Ensuring Global GxP Compliance (FDA 21 CFR Part 11, EU Annex 11)Streamlining CAPA and Change Control ProcessesManaging Quality Events and Non-conformancesCollaborating with External Partners (Suppliers, Labs)Real-time Risk-Based Decision Making

INTEGRATIONS

Veeva QualityDocsVeeva RIMVeeva SafetyVeeva CTMSERP (via API)LIMS (via API)MES (via API)CRM (via API)

COMPLIANCE & SECURITY

Compliance:
FDA 21 CFR Part 11EU Annex 11ISO 27001SOC 2 Type IIGxP
Security Features:
  • 🔒2FA
  • 🔒SSO
  • 🔒Encryption
  • 🔒Audit Trails
  • 🔒Access Control
  • 🔒Digital Certificates

SUPPORT & IMPLEMENTATION

Support: email, phone, live chat, dedicated account manager
Implementation Time: 1-3 months
Target Company Size: medium, enterprise
TRAINING AVAILABLE

PROS & CONS

✓ Pros:
  • +Unified system for end-to-end quality process control
  • +Strong compliance features (21 CFR Part 11, Annex 11, GxP)
  • +Seamless integration with other Veeva Vault applications (e.g., QualityDocs, RIM)
  • +Built-in best practices and automated workflows for rapid time-to-value
  • +Designed for global enterprise scale with external partner access
✗ Cons:
  • -Steeper learning curve and complex functionalities for new users
  • -Lengthy and complicated setup/implementation process
  • -Pricing is not transparent and is custom/enterprise-only
  • -Reported slower response times for customer support compared to competitors
  • -Less flexible in accommodating unique mid-market business requirements

ABOUT VEEVA SYSTEMS

Other software by Veeva Systems:
Veeva MedInquiry (Commercial & Medical AffairsMedical information systems)
Veeva Submissions (Regulatory Affairs & ComplianceSubmission lifecycle tracking)
Veeva Vault PromoMats (Marketing & Commercial OperationsPharma marketing automation (compliant))
Veeva Vault RIM (Regulatory Affairs & ComplianceRegulatory Information Management (RIM))