Tag Archive: ICH Q9

State of Validation

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…
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Biotech’s QRM is All-Around Changes in the ICH Q9 Guideline

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…
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