Overview
A pre-commercial, clinical-stage precision oncology company forged an internal partnership across IT, QA, FP&A, Legal, and USDM Life Sciences to make a fundamental process and cultural change to its validation methodology and to automate many IT workflows. The result was a rapid transformation that increased speed and efficiency across the organization.
The Challenge
The company was achieving strong clinical results and needed to ramp up its IT systems quickly. With minimal IT systems in place, it required a solution for regulated GxP IT Change Management and User Access Provisioning. As a regulated life sciences organization, it also needed those workflows to stand up to 21 CFR Part 11 expectations and to protect the integrity of its records as the business scaled.
- Two immediate needs: regulated GxP IT Change Management and User Access Provisioning.
- New to ServiceNow: the company had not yet adopted the platform.
- Traditional validation: an effort-heavy methodology that would slow every new system rollout.
The Approach
ProcessX was selected to address the need for regulated IT Change Management and User Account Provisioning. USDM showed the customer how easy it was to use all of the out-of-the-box workflows in the ProcessX module for regulated IT during deployment.
Because the additional workflows were so easy to deploy and maintain, the customer added four more: Incident Management, Cybersecurity Incidents, Regulatory Assessment, and Periodic Review. Standing up cybersecurity incident handling as a governed, repeatable workflow reinforced the company's broader life sciences cybersecurity posture.
Modernizing validation with CSA
During the project, USDM learned that the customer also wanted to roll out the FDA's new Computer Software Assurance approach to validation. USDM added that to the project scope to minimize the customer's validation efforts, shifting effort toward risk-based testing and away from low-value documentation. This continuous compliance mindset keeps systems audit-ready as they evolve.
The Results
The customer's original need was for two GxP workflows. USDM delivered six and modernized the customer's validation methodology, saving them significant time and money.
- 6 GxP workflows delivered against an initial ask of 2.
- Modernized validation using the CSA approach to reduce validation effort.
- No additional ServiceNow licenses required by ProcessX, which sped up onboarding for a customer new to the platform.
The customer now has a scalable GxP and non-GxP workflow solution to evolve with its emerging business. By pairing automated, regulated workflows with a modern validation methodology, the company turned a two-workflow request into a foundation for compliant growth, supported by ongoing data integrity across its records.