The Challenge: Regulated IT Had to Scale Before the Business Outgrew It
A pre-commercial, clinical-stage precision oncology company was seeing strong clinical momentum and needed to ramp up IT systems quickly. The company had minimal IT systems in place, but its operating environment already required controlled, auditable workflows for regulated GxP IT Change Management and User Access Provisioning.
The organization was also new to ServiceNow, so the implementation needed to avoid unnecessary licensing drag and validation overhead. Traditional validation would have slowed every new workflow rollout just as the business needed speed, traceability, and reliable data integrity.
- Two immediate workflow gaps: regulated GxP IT Change Management and User Access Provisioning.
- ServiceNow adoption pressure: the company needed a fast path without adding avoidable platform complexity.
- Validation burden: traditional CSV methods would have slowed the IT roadmap and consumed scarce internal bandwidth.
The Approach: ProcessX Workflows with CSA Built Into the Delivery Model
USDM deployed ProcessX to address the initial regulated IT workflow needs and showed the customer how quickly out-of-the-box ProcessX workflows could be configured and maintained for regulated IT operations.
Because the workflow model was straightforward to deploy, the customer expanded the scope from two workflows to six, adding Incident Management, Cybersecurity Incidents, Regulatory Assessment, and Periodic Review. Standing up cybersecurity incident handling as a governed, repeatable workflow also reinforced the company's broader life sciences cybersecurity posture.
Modernizing validation with CSA
During the project, USDM learned that the customer wanted to adopt the FDA's Computer Software Assurance approach. USDM added CSA to the delivery scope, shifting the validation model toward critical thinking, risk-based testing, and reusable evidence rather than low-value documentation. That change helped the team move faster while preserving continuous compliance.
The Results: Six Workflows and a Better Validation Operating Model
The customer's original need was for two GxP workflows. USDM delivered six, modernized the validation methodology, and helped the company avoid additional ServiceNow license requirements through ProcessX.
- 6 GxP workflows delivered against an initial ask of 2.
- CSA validation approach adopted to reduce validation effort and focus testing on regulated risk.
- No additional ServiceNow licenses required by ProcessX, accelerating onboarding for a customer new to the platform.
The company now has a scalable GxP and non-GxP workflow foundation that can evolve with the business. By pairing automated, regulated workflows with a modern validation methodology, the team turned a narrow two-workflow need into a governed operating model for compliant growth.