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Automating compliance with ICH Q8

By: 
Ian Lucas, Director, SeerPharma, Melbourne
Published : 
May, 2011

ICH Q8(R2) provides a quality risk-based framework for Pharmaceutical Development companies to implement in order to design a quality product and consistently manufacture to the intended performance of the product.
The outcome is enhanced knowledge on the product and the process.
As much data is collected, analysed and disseminated, an automated system that records and controls the development process greatly enhances the chances of successful compliance.

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