- Available Formats
- Priced From ( in USD )
Secure PDF Files
Secure PDF files include digital rights management (DRM) software. DRM is included at the request of the publisher, as it helps them protect their copyright by restricting file sharing. In order to read a Secure PDF, you will need to install the FileOpen Plug-In on your computer. The FileOpen Plug-In works with Adobe Reader and other viewers. Visit FileOpen to see the full list.
What you can do with a Secure PDF:
- Immediate download
- Add to Cart
- Secure PDF
Customers Who Bought This Also Bought
Priced From $48.00
GAMP Good Practice Guide: Electronic Data Archiving
Priced From $460.00
GAMP 5: A Risk-Based Approach to Compliant GxP Computeriz...
Priced From $570.00
GAMP Good Practice Guide: A Risk-Based Approach to Calibr...
Priced From $460.00
About This Item
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 softcover Guide. It provides supporting materials, including differences between GAMP® 4 and GAMP® 5, key diagrams, templates, forms, example documents, and background information. (CD is Windows compatible only.). If you order the secure PDF, these supplemental materials are included as downloads.