GAMP 5 Guide: Compliant GxP Computerized Systems

Bound Version

Member Price
$250.00 / €225.00
Non-Member Price
$570.00 / €490.00

Individual Download

Member Price
$250.00 / €225.00
Non-Member Price
$570.00 / €490.00

Published: February 2008
Pages: 356


Table of Contents Supporting Materials

Special Pricing for Emerging Economies - Learn More

Ten years after its publication, the ISPE GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems is regarded as the definitive industry guidance on GxP computerized system compliance and validation for companies and suppliers and is referenced by regulators worldwide.  Check our the article from Sion Wyn, member of the GAMP Community of Practice, on whether this guide is still current, and considers where the GAMP community should focus its efforts in the future.

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.

Valuable supporting materials, including key diagrams, templates, forms, example documents, and background information is available to download for purchasers of GAMP 5. A Zip file with these supporting materials will be provided to purchasers through the ISPE Bookstore. A detailed list of contents is included in the downloadable Zip file.

Available in German 

Available in French

GAMP 5: Ein risikobasierter Ansatz für konforme GxP-computergestützte Systeme GAMP 5: Une approche de la conformité des systèmes informatisés BPx basée sur les risques
GAMP 5 German Cover GAMP 5 French Cover

Inhaltsverzeichnis
(Adobe PDF 538 KB)

Individual Download

Member Price    Nonmember Price 
 $250 / €230       $570 / €500

BUY NOW

Table des matières
(Adobe PDF 467 KB)

Bound

Member Price   Nonmember Price 
 $250 / €230      $570 / €500

Individual Download

Member Price   Nonmember Price 
$250 / €230       $570 / €500

BUY NOW

为您提供中文版

Available in Chinese

您是中国母语人士,不能充分了解GAMP 5的英文版?您是否担心GAMP 5英文与中文有对比相差?

 

 

 

中文版GAMP 5由制药行业专家评审了几轮。在这长时间过程,专业小组在进行审查和翻译时利用了他们许多丰富的经验。阅读本技术文档后,您一定会更好地了解GAMP 5

 

请联系China@ispe.org了解更多详情并订购本行业指南

 

Are you a native Chinese speaker and worried about whether or not you can fully understand the English version of GAMP 5? Are you worried about having a contrast between the GAMP 5 English versus Chinese?

 
The Chinese GAMP 5 was reviewed several rounds by pharmaceutical industry experts. The dedicated review team went through a long review process and leveraged lots of their rich experience while doing the review and translation. You are sure to have a better understanding of GAMP 5 after reading this technical document.
Please contact China@ispe.org for more details and to order this industry guide.

 

日本語版のご案内

Available in Japanese

 

英語版だけでは十分に内容を把握しきれない、自信が無いという方、

英語版と合わせて日本語版を手に入れて、より一層の理解を深めてみませんか?

 

GAMP5日本語翻訳版は、製薬業界のエキスパートが集結し、その豊富な知識と

キャリアを生かし、十分に内容を吟味した上でレビューしたものをご提供しております。

会員のみならず、非会員の方からも大変ご好評を頂いております。

 

ISPE日本本部WEBサイトにて、GAMP5日本語版をご提供しております。

日本語版詳細およびご購入方法につきましては、Japan Affiliateのホームページを

ご確認ください。

Are you a native Japanese speaker and worried about whether you can fully understand the English version of GAMP5? Are you worried about having a contrast between the GAMP 5 English versus Japanese?
 
The Japanese GAMP 5 was reviewed several rounds by pharmaceutical industry experts. The dedicated review team went through a long review process and leveraged lots of their rich experience while doing the review and translation. You are sure to have a better understanding of GAMP 5 after reading this technical document.
Please visit the Japanese Affiliate for more details and to order this industry guide.