Rapid Deployment of Enterprise-Wide GxP Applications

The Challenge

An emerging biotech company was racing toward its first FDA submission, anticipated to be completed within 2 months. To enable commercialization activities, it needed to stand up its first-ever GxP applications — and do it fast. The scope spanned four enterprise systems: Veeva QualityDocs, Veeva Training (LMS), Okta SSO, and Microsoft Active Directory.

• Emerging biotech company implementing its first GxP applications
• Needed project management and accelerated validation to enable commercialization
• FDA approval anticipated to be completed within 2 months
• Aggressive timeline of just 12 weeks to deliver the project

With no prior GxP systems, SOPs, or computer software assurance procedures in place, the company had little margin for error and needed a partner who could move at startup speed without compromising regulatory rigor.

The Approach

USDM’s Emerging Life Sciences team planned, developed, and executed the full validation life cycle, providing consulting and accelerated validation for Veeva QualityDocs and Veeva Training while qualifying Okta SSO and Active Directory — all in 12 weeks. The engagement included:

• Review of documentation and gap assessment
• Development of SOPs for computer system validation (CSV)
• Planning for remediation
• Implementing and validating the new applications
• Assisting in developing and facilitating training for Veeva QualityDocs and Veeva Training
• Developing and executing an internal communication plan

End-to-end compliance procedures

Because these were the customer’s first GxP applications, USDM didn’t just validate the systems — it built the compliance backbone around them. USDM developed a comprehensive set of IT CSV procedures, including CSV, change management, disaster recovery, and IT system security, along with system admin and end-user SOPs for the new systems. With identity and access systems like Okta SSO and Active Directory in scope, this foundation also reinforced life sciences cybersecurity and reliable data integrity across the GxP environment.

USDM provided on-site test execution support and delivered end-to-end compliance that extended to cloud application updates — keeping the new systems validated as they evolved.

The Results

USDM delivered the entire enterprise GxP footprint on the aggressive timeline, putting the customer in position to meet its FDA submission deadline.

• 50% faster implementation of GxP applications
• 12 weeks to be audit-ready
• Fast-tracked internal knowledge of GxP applications with the help of USDM

By compressing validation into half the time and establishing durable Cloud Assurance practices, USDM turned a high-pressure deadline into a repeatable compliance foundation — one the biotech could carry forward as it scaled toward commercialization.