FDA Human Factors Resources

Wendy News

FDA Draft Guidance on Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: This draft guidance …

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

GregHUM 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 …

Cognitus and Kymanox Announce SAP Strategic Partnership

GregHUM New, News

Strategic alliance signed with SAP Gold Partner Cognitus FOR IMMEDIATE RELEASE MIAMI, April 24, 2020 /PRNewswire/ — Cognitus Consulting, LLC (Cognitus) and Kymanox Corporation (Kymanox) have approved a …