CASE STUDY

Life Sciences Case Study

Pharmaceutical Leader Uses CERDAAC to Transform Operations in Compliance With New FDA Regulations

Summary

What does a pharmaceutical company with millions of dollars invested in processes, people and equipment do when the entire industry’s compliance requirements suddenly change?

That is the challenge one pharmaceutical company faced when its industry transitioned from oversight under the rules governing compounding pharmaceuticals to FDA regulatory compliance. The company, which owns and operates a large, global network of PET radiopharmacies, turned to SIMCO’s CERDAAC software for the solution.

  • 400 users and 5,000 assets tracked
  • 43 sites using CERDAAC
  • Staff training and certifications also tracked in CERDAAC

“From a regulatory standpoint, it’s one of the key tools we use to show that we’re in compliance with the FDA’s requirements.”

Spokesperson for Leading Life Sciences Company