Veeva Vault QMS
by Veeva Systems · Healthcare & Life Sciences
Cloud QMS for life sciences managing deviations, CAPA, complaints, audits and change control.
Updated August 2026 · By the ERP Research Editorial Team · Independent and vendor-neutral.
- Deployment
- Cloud
- Company size
- Mid-market, Enterprise
- Pricing
- Quote-based
- Founded
- 2007
- Headquarters
- Pleasanton, California, United States
Overview
Veeva Vault QMS is a cloud-based quality management system built on Veeva's Vault Platform for biopharma, medical device and other life sciences companies. It is part of Veeva's broader Quality Cloud suite, which also includes QualityDocs, Training, Validation Management, LIMS and EHS applications that share the same underlying platform and data model.
The system provides configured, best-practice workflows for core quality processes: deviations, internal and external audits, complaints, lab investigations (OOS/OOT), change control and CAPA. Quality events can automatically trigger related deviations or CAPAs, automatic linkage between related records surfaces recurring patterns, and dashboards aggregate deviation, investigation, CAPA and audit data. Veeva names customers including GSK, Sanofi, Boehringer Ingelheim and Moderna.
Vault QMS connects to other Veeva Vault applications, such as RIM (regulatory) for change-control coordination and Safety for complaint intake, and exposes an open Vault API that customers and partners use to build integrations with adjacent systems, including ERP and LIMS platforms — though Veeva does not publish a certified ERP connector for Vault QMS.
Features & capabilities
Deviation & Investigation Management
End-to-end handling of deviations from intake through root cause.
- On-screen and mobile deviation forms
- Automated investigation task assignment
- "5 Whys" root-cause analysis tools
- Automatic linkage to related CAPAs
- Configurable severity and risk classification
- Comprehensive audit trails
CAPA Management
Corrective and preventive actions linked across quality events.
- Automatic CAPA creation from deviations, complaints or audit findings
- Linkage of related quality events to reveal patterns
- Effectiveness-check tracking
- Configurable approval workflows
- Dashboards aggregating CAPA status
Audits & Supplier Quality
Internal, external and supplier audit management.
- Internal and external audit planning and execution
- Audit finding-to-CAPA linkage
- Supplier change control and collaboration
- Real-time external partner access for investigations and corrective actions
Complaints & Lab Investigations
Complaint intake and OOS/OOT lab investigation handling.
- Complaint intake and triage
- Auto-triggering of deviations or CAPAs from complaints
- OOS/OOT lab investigation workflows
- Integration with Veeva Safety for complaint-to-adverse-event handoff
Change Control & Quality Risk Management
Coordinated change control and risk processes.
- Change control workflows
- Quality-RIM connection for regulatory coordination
- Quality risk management (QRM) processes
- Self-serve reporting across deviations, CAPAs, audits and complaints
Common use cases
- Running deviation and CAPA processes across multiple manufacturing sites with linked root-cause data
- Managing internal and external audits with findings that flow directly into CAPA
- Triaging customer complaints and auto-generating deviations or CAPAs when needed
- Coordinating regulatory change control between quality and regulatory affairs teams via the Quality-RIM connection
- Giving external contract manufacturers or suppliers real-time access to investigations and corrective actions
- Consolidating quality data for biopharma, CDMO and medical device organizations on one Vault Platform
- Building self-serve reporting dashboards that aggregate deviations, CAPAs, audits and complaints
Strengths & considerations
Strengths
- Single Vault Platform shared across QMS, QualityDocs, Training, LIMS, Validation Management and EHS, so quality records, documents and training share one data model
- Automatic linkage between related quality events (deviations, CAPAs, complaints, audit findings) surfaces patterns instead of treating each record in isolation
- Real-time external partner access lets CDMOs and suppliers collaborate directly on investigations and corrective actions
- Backed by Veeva's life-sciences-only focus and large installed base among biopharma, CDMO and MedTech companies
Pricing
Pricing is not published; cost depends on which Quality Cloud applications (QMS, QualityDocs, Training, LIMS, etc.) and user counts are licensed. Get an independent shortlist with pricing guidance below.
Technical & security
- Hosting
- SaaS (multi-tenant Vault Platform)
- Compliance
- 21 CFR Part 11
- Mobile app
- Yes
About the vendor
- Founded
- 2007
- Headquarters
- Pleasanton, California, United States
- Employees
- ~7,900
- Ownership
- Public (NYSE: VEEV)
- Notable customers
- GSK, Sanofi, Boehringer Ingelheim, Moderna
Alternatives to Veeva Vault QMS in Healthcare & Life Sciences
Veeva Vault QMS — frequently asked questions
Is Veeva Vault QMS validated for GxP use?
Yes. Vault QMS is built for GxP-regulated life sciences processes and supports 21 CFR Part 11 electronic records and signatures requirements with full audit trails.
What quality processes does Vault QMS cover?
It provides configured workflows for deviations, internal and external audits, complaints, lab investigations (OOS/OOT), change control and CAPA, with automatic linkage between related quality events.
Does Vault QMS integrate with SAP or other ERP systems?
Veeva does not publish a certified ERP connector for Vault QMS; integration with ERP systems such as SAP is typically built through the open Vault API for batch release and master data workflows.
What other Veeva applications does QMS connect to?
Vault QMS shares the Vault Platform with QualityDocs, Training, LIMS, Validation Management and EHS, and connects to Veeva RIM for change-control coordination and Veeva Safety for complaint handling.
Who uses Veeva Vault QMS?
Biopharma companies, CDMOs, generic drug manufacturers and medical device companies, including customers such as GSK, Sanofi, Boehringer Ingelheim and Moderna.
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