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GAMP 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. This technical document describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification. It points to the future of computer systems compliance by centering on principles behind major industry developments such as PQLI; ICH Q8, Q9, Q10; and ASTM E2500.
 
This revolutionary Guide addresses the entire lifecycle of an automated system and its applicability to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructures. It contains new information on outsourcing, electronic batch recording, end user applications (such as spreadsheets and small database applications), and patch management.
 
Conteúdo
 
1 Introduction
2 Key Concepts
3 Life Cycle Approach
4 Life Cycle Phases
5 Quality Risk Management
6 Regulated Company 
7 Supplier Activities
8 Efficiency Improvements
9 Appendices

Acabamento:
Edição: 2008
Formato:
Número de páginas: 322
Peso: 0,70

Atenção
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