Case Study: PSC Biotech achieves 10x FDA Form 483 throughput and 44% lower processing costs with Provectus

PSC Biotech cuts document processing costs 44% with Provectus

PSC Biotech, a global life-sciences consultancy, faced a significant challenge in manually reviewing thousands of FDA Form 483 observations. This process was slow, costly, and its accuracy was highly variable, creating a major bottleneck for regulatory compliance engagements where speed and precision are critical. Provectus addressed this by building a GenAI multi-label classifier on Amazon Bedrock.

The solution implemented by Provectus automated the classification of observations into over 100 categories, which was then validated by human reviewers via a dedicated UI. This resulted in a 10x increase in document throughput and a 44% reduction in per-document processing cost, saving an estimated 5,000 hours of labor annually for the customer.

PSC Biotech