Where to Start: Supplier Management Program Overview
Where to Start: Customer Inspection Support Program Overview
| Record Type | Document |
|---|---|
| Policy | Audit Management Policy |
| Procedures | Audit Management Procedure Supplier Management Procedure |
| Work Instructions | Audit Management WI Supplier Management WI |
The audit management program is divided into three domains:
Veeva is committed to supporting its customer’s regulatory obligation to perform due diligence on all GxP impacting services and software. As such Veeva has established and staffed a customer audit program to facilitate and respond to customer audit requests. As a SaaS vendor, Veeva understands that it may be called upon to support customers during a regulatory inspection (e.g., biennial GMP, BIMO sponsor audit, Pre-Approval Inspection). With appropriate notification, Veeva will establish a repository of all necessary documents, including validation documents and associated procedures to permit a secure, remote access for inspection review.
The corporate compliance group establishes an annual audit plan to determine whether the quality system is effectively implemented and maintained. The annual audit plan is defined on a risk-based approach, one that takes into consideration the significance of the process (KPA) and/or functional area as well as results from previous internal and customer audits. The corporate compliance group maintains procedures that specify requirements for the periodic assessment of the Veeva quality system. These procedures ensure that there is an appropriate level of commitment to address audit requirements, specify the activities to be performed, defines the risk-based approach and rationale, and ensure the auditors are independent of the area audited.
Veeva relies on its vendors and suppliers to provide a quality service that meets or exceeds company quality standards. Veeva has partnered with industry leaders to support its services, including AWS and SFDC. The corporate compliance group maintains procedures that specify requirements for the assessment of those vendors, suppliers and contractors, who provide services that may impact product and process quality. These procedures ensure that there is an appropriate level of oversight of our vendor’s quality systems. Veeva performs periodic audits on its own suppliers and partners to ensure products and services conform to Veeva established quality standards.
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