Creating Robust Building Maintenance and Environmental Monitoring Systems for Your CGMP-Compliant Facility

Kymanox News, Validation

by Faith Fraley, Director, CQV Engineering at Kymanox Every pharmaceutical manufacturing facility requires a controlled manufacturing environment. Temperature, humidity, and pressure are crucial to products …

Points to Consider When Validating Computer Systems for CGMP Processes

Kymanox New, Validation

Jim Falanga, Director, CSV Compliance Tara Doby, Sr. Validation Specialist Regulatory agencies, such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require …

Building Tomorrow’s FDA/EMA Compliant Intelligent Enterprise Solution

Kymanox Validation

by Brian Freymann, Director, Enterprise Solutions The core issue that drives compliant solutions is that drug, medical device, and instrumentation companies are monitored closely by …