Turning Point forges an internal partnership with IT, QA, FP&A, Legal, and USDM Life Sciences to make a fundamental process and cultural change to their validation methodology and automate many IT workflows for a rapid transformation that increased speed and efficiency across the organization.
The Situation:
Turning Point, a pre-commercial, clinical-stage precision oncology company, was achieving great clinical results needed to ramp up its IT systems rapidly. They had minimal IT systems in place and required a solution for regulated GxP IT Change Management and User Access Provisioning.
The Solution:
ProcessX was selected to address the customer’s needs for regulated IT Change Management and User Account Provisioning. USDM showed the customer how easy it was to utilize all out-of-the-box workflows in the ProcessX module for Regulated IT workflow during the deployment. The customer added four additional workflows for Incident Management, Cybersecurity Incidents, Regulatory Assessment, and Periodic Review because of the ease of deploying and maintaining the additional workflows. During the project, USDM learned that the customer also wanted to roll out the FDA’s new Computer Software Assurance approach to validation, so USDM added that to the project scope to minimize the customer’s validation efforts.
The Results:
Turning Point’s original need was for two GxP workflows. USDM delivered six and modernized the customer’s validation methodology, saving them significant time and money. The customer has a scalable GxP and non-GxP workflow solution to evolve with their emerging business. Since the customer was new to ServiceNow, USDM was able to speed up the onboarding because ProcessX does not require additional licenses for ServiceNow.
