Greater validation efficiency through a hybrid CSA model
USDM worked in collaboration with a large pharmaceutical company to update its internal validation processes and enhance the efficiency of its testing activities. With USDM's expertise and assistance, the company moved away from a traditional Computer System Validation (CSV) model to a new hybrid Computer Software Assurance (CSA) model.
The Challenge
The client is a pharmaceutical company focused on research, development, and manufacturing — primarily across dermatology, oncology, and specialty injectable therapeutic areas. Its validation program had become a bottleneck:
- A cumbersome, traditional CSV process was in place for validation
- Validation activities were time-consuming and required an excessive amount of documentation
- Heavy scripted testing and paperwork pulled engineering time away from critical testing
The company needed a leaner, risk-based path that still held up to 21 CFR Part 11 expectations and protected data integrity across its computerized systems.
The Approach
USDM partnered with the company's internal team to re-work its entire validation structure and shift to a true risk-based methodology:
- Moved the company's internal processes from traditional Computer System Validation (CSV) to a hybrid Computer Software Assurance (CSA) process
- Helped the company recreate internal SOPs and templates to gain efficiencies
- Built comprehensive, standardized procedures for the company's testing activities and trained internal teams to own them
This work reframed validation as an ongoing, risk-prioritized discipline rather than a documentation exercise — the same principle behind USDM's broader continuous compliance approach.
The Results
- The company significantly reduced the number of scripted tests in its validation processes
- It reduced the time spent documenting procedures, freeing up more time for critical testing
- USDM delivered comprehensive, standardized procedures for the company's testing activities and trained internal teams to sustain them
The draft procedures and tools USDM collaborated on are now the basis for CSV at the company.
In the client's words
“USDM provided a great framework for re-aligning our cumbersome CSV process to adopt the CSA methodology. Their experience and insight on this true risk-based approach really helped shift mindsets from documentation-focused to testing-focused. The draft procedures and tools they collaborated with us on are now the basis for CSV at our company.” – Process & Project Development Engineer
Validation that works the way your teams do
By replacing a documentation-heavy CSV process with a hybrid, risk-based CSA model, USDM helped this pharmaceutical company spend less time on paperwork and more time on the testing that actually reduces risk. To see how a risk-based CSA approach could streamline your validation, talk with USDM's CSA experts.