Application of GLP Principles to Computerised Systems
This document introduces a life cycle approach to the validation and operation of computerised systems. It emphasises risk assessment as the central element of a scalable, economic and effective validation process with a focus on data integrity. The intention of this document is to provide guidance...
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| Format: | eBook |
| Language: | English |
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Paris
OECD Publishing
2016
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| Series: | OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring
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| Collection: | OECD Books and Papers - Collection details see MPG.ReNa |
| Summary: | This document introduces a life cycle approach to the validation and operation of computerised systems. It emphasises risk assessment as the central element of a scalable, economic and effective validation process with a focus on data integrity. The intention of this document is to provide guidance that will allow test facilities to develop an adequate strategy for the validation and operation of any type of computerised system, regardless of its complexity, in a GLP environment |
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| Physical Description: | 32 p |
| ISBN: | 9789264853799 |