Deb Groskreutz has 20 years experience in Information Technology, Bioinformatics, software development and validation in the regulated Life Sciences industry.

Deb entered the field of bioinformatics and database systems after doing molecular biology research in pharmaceutical and biotech environments. She is an accomplished scientist and author, having published in peer-reviewed journals such as the Journal of Biological Chemistry and Human Gene Therapy. Deb specializes in custom software development, bioinformatics, data delivery methods and relational databases. As a Developer, Database Administrator and Compliance Consultant, she develops, installs, customizes and validates software for regulated companies around the world.

 

Deb served as a Principal Software Engineer for more than 10 years at a leading developer, manufacturer and supplier of diagnostic and medical products. She was the software/IT representative on the team that developed the internal Software Development Life Cycle (SDLC) processes to ensure compliance with US FDA regulatory standards and guidelines. She then used the risk-based SDLC process in the development, integration and implementation of custom and off-the-shelf software solutions for Quality Control, Quality Assurance, Research, Manufacturing and Clinical Trial departments. In her role as the Lead Developer, Deb created and used coding standards, testing, traceability, and 21 CFR Part 11 sign-off tools and mechanisms to confirm that all custom and off-the-shelf software were validated and approved before release into the production environment. The custom database and web interface application project that Deb most recently led became the Quality Control and Quality Assurance (QC/QA) sign-off/release, tracking and trending tool for clinical testing kits; it has been in production for over 9 years.

 

Since 2006, Deb has been providing software and database development and regulatory compliance consulting services for Life Science companies adhering to US FDA and other regulated body regulations and guidelines. She holds a Master of Arts in Cellular and Molecular Biology from San Francisco State University, a Secondary Education teaching credential from Chapman University, and a Bachelor of Arts in Biology from Augustana College in Sioux Falls, South Dakota.