Cognitus and Kymanox Announce SAP Strategic Partnership

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 strategic partnership to streamline FDA compliant SAP S/4 HANA solutions for Life Sciences organizations. The joint offering is being branded as “Gallop for Life Sciences – …

Points to Consider When Validating Computer Systems for CGMP Processes

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 life science companies to have controls on computer systems that are used to manage CGxP electronic data and records.  As part of the implementation and maintenance …

Building Tomorrow’s FDA/EMA Compliant Intelligent Enterprise Solution

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 the FDA/EMA. The regulatory requirements are designed for the purpose of managing all data that has an impact on patient safety. Both the FDA’s Title …