OR WAIT null SECS
© 2023 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2023 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
July 02, 2008
A new book explains process analytical technology, drug stability, and quality.
July 02, 2007
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.
September 01, 2003
Part I of this article was published in the March 2003 issue of 21 CFR Part 11: Compliance and Beyond. In this issue, Part II discusses the potential advances and changes that must be made for computer validation to remain innovative and relevant to the industry.
November 02, 2001
In Part II of this article, the authors discuss the types of specifications and the installation, testing, contingency planning, documentation, and implementation of required validation for networks.
October 02, 2001
Part I of this article discusses validation plans, FDA expectations, and specific requirements for the validation of networked systems.
September 02, 2001
The authors forecast how the current industry events and trends will affect computer validation in the future.