Veeva is a company devoted to providing software-as-a-service (SaaS) to clients in the regulated sector who wish to utilize mobile and outsourced cloud-based solutions. While Veeva does not develop, produce, or market regulated healthcare products, our customers are engaged as such and are subject to global healthcare laws and regulations. Veeva recognizes that its quality system must therefore assist its customers in meeting the requirements of the U.S. Food and Drug Administration (FDA) and other global regulatory agencies where Veeva’s clients do business (e.g., EMA, MHRA, PDMA). At Veeva, Quality is not simply a regulatory obligation, it is also our competitive advantage. As such, we have designed and implemented a Quality Management System (QMS) that is aligned with our customers’ regulatory standards of compliance in Information Technology.
Veeva’s Quality, Regulatory, and Compliance Group (QRC)
The Quality Regulatory & Compliance (QRC) group is functionally independent of product development and operations. The QRC function is divided into four functional domains, each managed by a responsible area head, covering:
Quality Operations
- CAPA - Quality review of critical non-conforming product (Incidents)
- Change Management - Product releases and patches
- Records Management - Process definition and document control
- Resource Management - Onboarding of personnel and training management
- Risk Management - Quality risk management
Audit & Inspection Management
- Audit Management - Support of customer audits, regulatory inspections, and internal audit program
- Management Review - Executive management review of QMS
- Supplier Management - Audit of external vendors, partners and suppliers
Computer Systems Validation
- Computer Validation - Oversight of validation of Veeva products and internal business systems
Regulatory Intelligence
- Regulatory Intelligence - Monitoring and interpretation of regulations and impact on business
Veeva QR&C staff have extensive experience in the pharmaceutical and medical device industry, covering quality operations, corporate audits, regulatory inspections, IT operations, computer validation, and IT controls in an FDA/EMA-regulated environment.
Key domains relating to the Quality Management System Include:
Veeva’s Certifications
Veeva’s certificates (ISO/SOC/HDS) can be found here.
Knowledge Articles
Quality Regulatory Compliance - Body of Knowledge
Boundary Conditions of the QMS