Case Study: a leading pharmaceutical company achieves FDA compliance across 43 sites with SIMCO CERDAAC

Pharmaceutical leader with large network of PET radiopharmacies uses SIMCO CERDAAC to transform its operations in compliance with new FDA regulations

A leading pharmaceutical company with a large network of PET radiopharmacies faced a significant challenge when new FDA regulations (CGMP 212) required a complete transformation of its manufacturing process controls and reporting. The company needed a sophisticated system to track equipment calibration, maintenance, and staff qualifications across its 43 sites, as its existing Oracle ERP and other off-the-shelf solutions were inadequate. The vendor, SIMCO, provided its CERDAAC software to address this compliance challenge.

The solution involved implementing SIMCO's cloud-based CERDAAC software to manage asset calibration, maintenance, and, uniquely, employee certifications and licenses. This allowed the company to achieve full compliance with FDA regulations, successfully undergoing 34 audits in a single year. The measurable results include over 400 employees using CERDAAC to track 5,000 assets and critical staff qualifications across all 43 US sites, ensuring no renewal dates or compliance requirements are missed.