Validation of Computerized Analytical and Networked Systems

You cannot afford to be in the dark when it comes to validating your analytical systems and lab software. Written by international laboratory and compliance expert Dr. Ludwig Huber, Validation of Computerized Analytical and Networked Systems is an invaluable validation tool. Covering the initial writing of the validation plan through implementation, testing, and installation qualification, through ongoing calibration, performance qualification, and change control, the book provides guidance throughout the entire validation process.

Huber pays special attention to 21CFR Part 11 electronic records and signatures compliance, including recommendations for implementation and the scope of Part 11 for chromatographic systems. He discusses vendor assessment, covers the criteria and procedures for vendor audits, and includes vendor assessment checklists. He also explores the validation of complex networked systems and "office software" such as Macros, spreadsheets, and databases, and the operational compliance of legacy systems. The book contains everything you need to perform computer systems validation cost-effectively and in a manner acceptable to national and international regulatory agencies.