Learn how USDM enabled compliance for multiple IT systems in half the time for a start-up biotech customer to meet their FDA submission deadline. Emerging companies don’t have the time or resources to solve all their unique IT challenges as fast as they need to keep up with the competition. USDM’s vast experience with start-ups can save time and deliver best-in-class solutions to rapidly deploy cloud technologies and reduce regulatory risk.

The Situation
  • Emerging biotech company
  • Implementing QMS, LMS, Okta SSO, and Active Directory
  • Needed project management and accelerated validation to enable commercialization activities
  • FDA approval was anticipated to be completed within 2 months
  • These were first GxP applications for the customer
  • Aggressive timeline of 12 weeks to deliver project
The Solution
  • USDM’s Emerging Life Sciences team planned, developed, and executed the validation life cycle activities including;
    • Review of documentation and gap assessment
    • Development of SOPs for CSV
    • Planning for remediation
    • Implementing and validating new applications
    • Assisted in developing and facilitating training for QMS and LMS applications
    • Developed and executed internal communication plan
  • USDM provided consulting and delivered accelerated validation for QMS and LMS and qualified Okta SSO and Active Directory in 12 weeks
  • USDM developed a comprehensive set of IT CSV procedures including: CSV, change management, disaster recovery, and IT system security
  • USDM developed system admin and end-user SOPs for new systems
  • USDM provided on-site test execution support
  • USDM delivered end-to-end compliance including cloud application updates

50% FASTER implementation of GxP Applications


Fast-tracked internal knowledge of GxP applications with the help of USDM

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