July 18, 2024 || Cody Beaumont
Originally issued in 2005, ICH Q9 laid down principles and examples of tools for QRM that can be applied throughout the product lifecycle. It was a groundbreaking step towards integrating risk management into pharmaceutical quality systems, encouraging a proactive approach to potential risks, and fostering a culture of continuous improvement.…
November 27, 2023 || Jonathon Thompson, Director - Product Management
CAI, Kneat Solutions, and others have partnered again in 2023 to conduct the annual State of Validation survey. The survey targets current professionals in a validation, quality, or compliance function in industries governed by Data Integrity or ICH, FDA, and EU GMP Guidelines. This year’s survey results concluded that the…
November 20, 2023 || Rosario Hughes-Kielty
To foster greater success and reduce failure rates within the biotechnology industry, it has become imperative for companies to establish robust risk management plans. Quality Risk Management (QRM) principles have emerged as a key strategy in achieving this goal. QRM details a comprehensive evaluation of risks associated with both patient…
