- USDM and Box provided their proprietary innovative approach to maintaining GxP compliance in the cloud.
- Box helped alleviate difficulties accessing data behind the national firewall in China.
- 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.
- USDM 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.
- USDM maintains the validated state of the customer’s Box instance and manages all patches, updates, and changes to enable a continuous state of compliance.
Learn more about expanding your Box GxP instance to a complete QMS solution.
cloud validation achieved with with minimal customer support
by outsourcing CSV and GxP tasks to USDM’s knowledgeable team
validation completed within customer timeline.