The Veeva process documents are structured in accordance with the ISO documentation hierarchy, with each policy and procedure aligned to a key process area. The Quality & Compliance (Q&C) group oversees all QA controlled documentation as defined by the Document Control Procedure. (QV-00084). Numourous policies outline the process framework at Veeva, covering the four operational pillars: Product Lifecycle, Services, Operations (including Security), and Quality Management. A Quality Policy guides Veeva employees with respect to their individual quality responsibilities and defines Veeva’s corporate commitment to Quality and the Life Sciences. A Quality Manual defines and delimits the QMS framework, including management responsibilities, product realization, and non-conforming product.
Quality documentation is maintained electronically in Veeva’s QualityDocs Vault. This Electronic Document Management System (EDMS) ensures:
- Secure (role-based) repository of all Quality Systems Record
- Global accessibility of key documents across Veeva sites
- Part 11 compliant e-signature and audit trail
- Read and understand workflow and acknowledgement of training