Validation

• Understanding the Basics of Automation Validation

  Understanding the Basics of Automation Validation If you are new to the pharmaceutical industry, or any other FDA-regulated industry, and are interested in learning more about validation as it pertains to automated systems, this article will serve as a high-level introduction to the basic concepts and standard requirements. Regardless of your specific role within the […]

  Read MoreRob Goldsmith / 21 CFR Part 11  / Automation  / Automation System  / Engineering  / FDA  / Functional Specification  / GAMP 5  / Standards  / Traceability  / Validation 

• Key Concepts of Machine Safety Verification and Validation

  Safety First  At Matrix Technologies, safety is one of our core values. In fact, we have a program called “Believe in Zero,” which means we strive every day to not have a reportable OSHA incident. We provide all necessary protections for our employees, and we put their safety first. Our concern about safety extends to […]

  Read MoreCarl Bohman, PE / Estop  / General Duty Clause  / Machine safety  / OSHA  / Risk Assessment  / Safety  / System Fault  / Validation  / Verification  / Safety  / SISTEMA 

• Integrating an HTST Skid to Prevent Biopharma Cell Culture Contamination

  Integrating an HTST Skid to Prevent Biopharma Cell Culture Contamination One of the most critical challenges of biopharmaceutical manufacturing is cell culture contamination prevention. Contamination of nutrients used to grow cells means scrapping the whole product and starting over, potentially costing the manufacturer millions of dollars. Here’s how Matrix Technologies recently helped one of the […]

  Read MoreGreg Pfleghaar / Biopharmaceutical Manufacturing  / Good Documentation Practices  / HTST Skid  / System Integration  / Validation  / Improvement  / Planning  / ControlLogix  / Integrations  / Upgrades