Overview
A leading SaaS life sciences supply chain software vendor needed to scale up its business, take on more customers, and keep its software FDA and 21 CFR Part 11 compliant — without ballooning its full-time headcount. USDM partnered with the vendor to deliver onsite and remote, on-demand compliance staff augmentation that became a true extension of their internal team.
The Challenge
The client is a SaaS life sciences supply chain software vendor with a customized product for biopharma that supports GxP business processes. Because the company provides its customers with custom configurations and validation, every new customer added validation work — and that work had to meet regulatory expectations for data integrity and software assurance.
- The company needed to scale validation capabilities for a growing customer base without incurring new full-time employees.
- It wanted an “on-demand” partner that would provide a team of validation engineers and project managers, trained on its internal system and SOPs, who could be deployed on short notice.
- It wanted a trusted, life sciences savvy partner that acted as an extension of its internal team and could take over the entire validation project management aspect of the business.
The Approach
USDM provided a team of 10 people to support the effort — validation engineers, validation analysts, business analysts, and project managers — blending strong GxP resources with deep life sciences experience.
A trained core team that removed the burden
- USDM designated four of those people as a core expert team to learn the system, manage and train other team members, and assimilate into the company culture — removing that burden from the customer.
- USDM could provide the right blend of GxP resources with life sciences experience in as little as a one-week turnaround, so validation capacity flexed with demand.
- USDM developed and used a library of reusable test protocols that is leveraged for new implementations, accelerating each subsequent validation.
Treating the engagement as an extension of the client's team meant compliance stayed front and center: this kind of trusted, ongoing model is the foundation of continuous compliance, and disciplined oversight of an external delivery team mirrors strong third-party risk management practices.
The Results
The on-demand model let the vendor take on more customers while keeping software compliant and validation predictable:
- 50% faster validation time.
- 50% decrease in validation costs.
- A trusted partnership established for 2+ years.
By handing off validation project management to a trained, on-demand USDM team, the client scaled its customer base without scaling fixed costs — and kept its supply chain software FDA and Part 11 compliant throughout. The reusable protocol library and embedded core team turned validation from a growth bottleneck into a repeatable, faster, lower-cost capability.