It aims to achieve process control systems that are fit for intended use and compliant with applicable regulations; providing recommended good practice based on a life cycle approach for the development, maintenance,and management of process control systems. The Guide applies science-based Quality Risk Management, as described in ICH Q9 and GAMP 5. It describes the system life cycle from concept to retirement,providing a high level overview of the approach together with guidance on how activities might be scaled based on risk to product quality, system novelty, and complexity as well as other project specific factors.
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Bound Version
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Member: $145 / &euro115
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Order your copy here:
Bound Version
or Individual Download PDF
Member: $145 / &euro115
New Member*: $384 / &euro325
NonMember: $405 / &euro345 *New Member Fee includes a one-year Membership in ISPE - a $239 value.
