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Guidance Document License Agreement

The contents of ISPE’s guidance documents, both printed and digital, are protected by law and intended solely for the personal non-commercial use of the individual purchaser.

Reproduction of multiple copies of these materials, in whole or in part, for the purposes of commercial distribution is prohibited.

Membership discounts are available only to current members and are intended for individual use of the guides, not for resale.

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Selected currency: US Dollars.
 
Bundle: GAMP 5 1st Ed (Bound) and GAMP 5 2nd Ed (Download)
Bundle: GAMP 5 1st Ed (Bound) and GAMP 5 2nd Ed (Download)
Bundle: GAMP 5 1st Ed (Bound) and GAMP 5 2nd Edition (Download)
Discounted member price: 495.00
795.00
You could save 37.7%

Special Bundle Deal for First-Time Purchasers of GAMP® 5 (First Edition): First-time purchasers of GAMP® 5 (First Edition) who purchase GAMP® 5 (First Edition) from 1 March - 29 July 2022 may pre-order the Second Edition download at a special price. This offer cannot be combined with other offers or the Emerging Economy discount.

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.

Maintaining the principles and framework of the First Edition, GAMP® 5 (Second Edition) is newly revised and expanded to address the increased importance of service providers, evolving approaches to software development, and the more widespread use of software tools and automation. It highlights the use of Critical Thinking by knowledgeable and experienced SMEs to define appropriate approaches.

Member Price: $ 495.00
Non Member Price: $ 795.00
Item #: G5BUNUS

Author: ISPE
Publisher: ISPE