Ludwig Huber

Ludwig Huber is worldwide product manager for pharmaceutical solutions at Agilent Technologies GmbH, PO Box 1280 D-76337, Waldbronn, Germany, tel. +49 7243 602 209, fax +49 7243 602 501.

This article provides a historical review of computer validation in the pharmaceutical industry within the last three decades, evolving from the early years' initial concept and approach to today's current practices. Also included is how the regulations and industry have progressed in addressing the topic of computer validation.

Risk analysis and evaluation of software and computer systems is a good tool to optimize validation costs by focusing on systems with high impact on both the business and compliance.

In 1997, the US Food and Drug Administration issued a regulation"Rule 21 CFR Part 11," that provides criteria for the acceptance of electronic records, electronic signatures, and handwritten signatures (1). FDA issued the guidance in response to requests from the industry. With this regulation, electronic records can be equivalent to paper records and handwritten signatures. The rule applies to all industry segments regulated by FDA that include good laboratory practice, good clinical practice, and current good manufacturing practice.

Part I of this article discusses validation plans, FDA expectations, and specific requirements for the validation of networked systems.