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 and processes. Deviations can be disastrous, but environmental controls mean nothing if they aren’t properly qualified and validated. A programming issue with humidity controls could …

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 …

KYMANOX TEAM HIGHLIGHT: Meet Aly Egan

Aly Egan, Quality Engineer and Team Lead, joined the Kymanox team in September 2018 with five years of industry experience. Aly enjoys working at Kymanox because the team is made up of bright, fun, and welcoming people who make her happy to go to work every day. She finds everyone …

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 of skipping the commissioning phase.  After vendor startup of equipment or after a minimum of air test and balance and room walkthroughs for a facility, …

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 management. Luke finds inspiration at Kymanox when he is required to “think outside the box” of quality and regulatory guidelines. He welcomes this challenge of …

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” Award in Nov 2017, and again in May 2018! Cristian’s favorite part of working at Kymanox is being part of an organization that puts patient …

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 has over 25 years of experience in the life sciences industry. Michael loves being part of Kymanox and is fulfilled by guiding the team in …

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 Emerging Leader Award at the 2019 Kymanox Annual Meeting due to his commitment to the team and living our core values at work every day. …

KYMANOX TEAM HIGHLIGHT: Meet Samer Salhani

Samer Salhani joined Kymanox as an Associate Process Engineer in May 2019 and as one of the members of the first Kymanox Academy class. He has since joined the Validation/CQV Engineering group full time. He brings with him experience from the life sciences and the semiconductor industry. Samer loves working at Kymanox …