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Onsite and Remote On-Demand Compliance Staff Augmentation

data integrity in life sciences

On-Demand Staff Augmentation With USDM

Learn how USDM partnered with a leading SaaS life sciences supply chain software vendor to scale up their business, allowing them to take on more customers and ensure their software was FDA and Part 11 compliant.

The Situation
  • SaaS life sciences supply chain software vendor with a customized product for biopharma that supports GxP business processes
  • Company provides its customers with custom configurations and validation
  • Company needed a solution to scale validation capabilities for growing customer base without incurring new full-time employees
  • Company wanted an “on-demand” partner that would provide a team of validation engineers and project managers who would be trained on their internal system and SOPs that could be deployed with short notice
  • Company wanted a trusted, life sciences savvy partner that acted as an extension of their internal team to hand off the entire validation project management aspect of their business
The Solution
  • USDM provided a team of 10 people to support this effort: validation engineers, validation analysts, business analysts, and project managers
  • USDM further used four of those people to become the core expert team to learn the system, manage and train other team members, and assimilate into the company culture to remove this burden from the customer
  • USDM was able to provide the right blend of strong GxP resources with life sciences experience in as little as a one-week turnaround
  • USDM developed and used a library of test protocols that is leveraged for new implementations

The Results

  • 50% faster validation time​
  • 50% decrease in validation costs​
  • Trusted partnership established for 2+ years

Learn more about our Consulting and Specialized GxP Talent.


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