ValidationVault^TM Compliance Resource CD

Electronic Reference Library of FDA Compliance Resources

New April 2009 Edition

EduQuest’s new ValidationVault Compliance Resource CD gives you desktop access to a treasure-trove of FDA laws, regulations, guidances, inspection protocols, warning letters, and international guidelines – all impacting your validation activities and decisions.

The CD has been assembled by EduQuest’s top validation experts – including Martin Browning, co-author of FDA’s Part 11 rule – specifically for those involved in computerized systems validation, quality management, software development, or electronic records/signatures compliance.

Included in the ValidationVault Compliance Resource CD are the latest versions of  FDA’s Investigations Operation Manual (IOM), relevant Title 21 CFR regulations, a complete library of FDA guidance documents related to validation and Part 11, key ICH guidelines, and much more.

ValidationVault Compliance Resource CD
Table of Contents:

• Unabridged text of laws enforced by FDA
• Unabridged text of key regulations enforced by FDA – Title 21 CFR
• Library and Chronology of FDA Guidance Documents related to computerized systems, software, electronic records/signatures and other automated systems
• FDA warning letters related to automated systems used for GxP compliance
• International Guidance Documents and guidelines (including PIC/S, GHTF, ICH, and EudraLex)
• And much more

Cost of the ValidationVault Compliance Resource CD is $295, including shipping and handling. The latest edition of the CD is available free to all students who attend EduQuest’s “FDA Auditing of Computerized Systems and Part 11” course held nationwide ( click here for upcoming course schedule).