DURHAM, NC — October 6, 2020 — Kymanox, a full-service life sciences solutions provider supporting commercialization of vital medicines and treatments, today announced the addition …
Creating Robust Building Maintenance and Environmental Monitoring Systems for Your CGMP-Compliant Facility
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
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 …
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 …
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 …
Response to COVID-19 Pandemic: Kymanox Actions and Capabilities
Kymanox has been doing its part to slow the spread of COVID-19 virus and has been taking prudent proactive measures over the past couple of weeks.
KYMANOX TEAM HIGHLIGHT: Meet Aly Egan
Aly has seen how Kymanox cares about clients’ needs and projects in many instances. When a client requested more resources than originally planned and allocated, …
COMMISSIONING: An Opportunity to Test, Challenge, and Improve the System Prior to Qualification
Commissioning gives biopharmaceutical companies the opportunity to work out the kinks in their equipment prior to qualification for GMP activities. However, companies make the mistake …
KYMANOX TEAM HIGHLIGHT: Meet Luke Oltmans
Luke Oltmans, Senior Quality Engineer and Team Lead, joined the Kymanox team in August 2018 with ten years of experience in manufacturing engineering and project …
KYMANOX TEAM HIGHLIGHT: Meet Cristian de la Cotera
Cristian de la Cotera, Quality Engineer, Team Lead, has been with Kymanox since July 2016. He was the recipient of the Kymanox “Be Of Service” …
KYMANOX TEAM HIGHLIGHT: Meet Michael Denzer
Michael Denzer, our Vice President of Technical Solutions and a member of our Senior Leadership Team at Kymanox, joined the team in March 2019 and …
KYMANOX TEAM HIGHLIGHT: Meet Steve Mazzarelli
Steve Mazzarelli, Senior Process Engineer at Kymanox, joined the team in July 2015 and has over 10 years of life sciences experience. He received the …