USDM achieved start-to-finish configuration and validation of the customer's new Box instance for GxP regulated data in two months, including CSV-compliant deliverables.
The global clinical-stage biopharmaceutical company is focused on discovering and developing novel drugs to treat chronic liver diseases, gastrointestinal diseases, and metabolic disorders with high unmet needs. Founded in Shenzhen, China, they also have a location in the United States.
The Challenge
The customer needed quick validation of their new Box instance to house regulated GxP data in preparation for a Food and Drug Administration (FDA) submission. Several factors made the project demanding:
- They had trouble accessing data in China due to the national firewall.
- The customer did not have significant Computer System Validation (CSV) or GxP regulatory experience.
- The start-to-finish validation timeline was an aggressive two months.
With regulated data destined for an FDA submission, the evidence behind the Box instance had to satisfy 21 CFR Part 11 expectations and stand up to audit scrutiny — leaving no room for shortcuts despite the compressed schedule.
The Approach
USDM and Box provided their proprietary, innovative approach to maintaining GxP compliance in the cloud. Box helped alleviate the difficulty of accessing data behind the national firewall in China, while USDM delivered the validation rigor required for a regulatory submission.
- USDM delivered an extensive validation plan and a defensible report using the CSV approach that can be submitted for FDA audits.
- USDM developed and performed Installation Qualification (IQ) and Performance Qualification (PQ) testing during onboarding and initial validation.
- USDM assisted in developing the Administrative Standard Operating Procedure (SOP) to establish change control guidelines.
- USDM's automated testing tool minimized the CSV effort.
By applying a risk-based, Computer Software Assurance mindset and focusing testing where it mattered most, USDM kept the validation defensible while preserving the underlying data integrity of the regulated content. The engagement also saved the customer from having to hire in-house FTE resources and needed minimal support to deliver the project, allowing the existing IT team to focus on other priorities.
The Results
- Compliant, defensible, continuous cloud validation achieved with minimal customer support.
- Saved the cost of 3 full-time employees by outsourcing CSV and GxP tasks to USDM's knowledgeable team.
- 2-month validation completed within the customer's timeline.
Beyond the initial submission, USDM maintains the validated state of the customer's Box instance and manages all patches, updates, and changes through USDM Cloud Assurance to enable a continuous state of compliance — so the environment stays audit-ready long after go-live.
Learn more about expanding your Box GxP instance to a complete QMS solution.