Veeva Vault Implementation to Maximize GxP Uses

The Challenge

An emerging clinical-stage, Phase 1 biotechnology company with fewer than 150 employees was replacing a legacy application and needed support implementing and validating the GxP workflows for its regulatory submission process.

• The customer needed support with the implementation and validation of the GxP workflows for their regulatory submission process
• The customer needed continuous cloud compliance support to manage Veeva's regularly scheduled updates and releases
• The customer required a high-performance team and project management services to accelerate and enable commercialization activities
• The customer needed Organizational Change Management (OCM) to ensure adoption across the organization

With a lean team and no margin for rework, every GxP workflow had to be implemented and validated correctly the first time — making a risk-based assurance approach and dependable 21 CFR Part 11 compliance essential from day one.

The Approach

USDM was selected for the project because of our Veeva expertise. We assisted with the implementation and validation of the end-to-end workflows for the regulatory submission process on an accelerated timeline, and managed the customer's project team to ensure their regulatory compliance requirements were delivered correctly and on time.

• End-to-end implementation and validation of the regulatory submission workflows, built to protect data integrity across the GxP process
• Resilient delivery through COVID-19 — despite the customer team being displaced by remote-working mandates, USDM kept all stakeholders aligned and pivoted quickly to deliver all necessary system training requirements virtually
• Virtual Organizational Change Management training for key stakeholders and system users to drive faster adoption
• Continuous compliance for the Veeva Regulatory Submissions Vault, with USDM continuing to handle change management for every Veeva update through Cloud Assurance

Built for continuous compliance

Veeva releases on a regular cadence, and each update can affect validated GxP functionality. Rather than re-validate reactively, USDM applies continuous compliance practices so the Vault stays inspection-ready release after release — relieving the customer's internal team of that recurring burden.

The Results

• Precise execution and implementation for GxP workflows and uses
• Delivered on time and on budget despite COVID-19 business continuity disruptions
• Relieved the burden of change management for Veeva updates

USDM achieved end-to-end compliance for the customer's Veeva Regulatory Submissions Vault implementation and continues to handle the customer's change management with every Veeva update to ensure continuous compliance.

Why USDM?

USDM helps life sciences organizations maintain, optimize, and continuously improve their Veeva Vault platforms through expert advisory services, managed application support, and Cloud Assurance — turning Vault from a system of record into a platform that accelerates business operations. With 250+ Veeva projects and 25 years of regulatory expertise across 900+ organizations, USDM delivers post-implementation governance, compliance readiness, automated testing, and operational support that reduces technical debt and drives measurable gains like 20–40% faster document approvals and up to 50–80% reduction in security profiles.

Ready to maximize your Veeva Vault investment and stay compliant through every release? Talk to a USDM Veeva expert.