Selected currency: US Dollars.
Change to EUROS
 
GAMP 5, French (Download) - USD
GAMP 5, French (Download) - USD
GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Fifth Edition) (Individual Download) - USD
Discounted member price: 250.00
Your price: 570.00
You could save 56.1%
Quantity:

GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems

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.

An exciting new innovation is the CD* accompanying the Guide. It provides supporting materials, including differences between GAMP® 4 and GAMP® 5, key diagrams, templates, forms, example documents, and background information.

Also available in German.

Also available in English.

Member Price: $ 250.00 / € 230.00
Non Member Price: $ 570.00 / € 500.00
Item #: 5BOUNDFDLUS


**  New Not a Member?  Join now and get Member Pricing on your purchase!

Please note: ISPE does not pay customs or duties on international shipping.

View Our Shipping and Return Policy