Articles by Ludwig Huber - Pharmaceutical Technology

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Articles by Ludwig Huber

A Perspective on Computer Validation

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.
Jul 2, 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.

Risk-Based Validation of Commercial Off-the-Shelf Computer Systems

Nov 1, 2005

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.

21 CFR 11 Overview of the Final Document and its New Scope
Ludwig Huber

This article provides an overview of Rule 21 CFR Part 11's key requirements and its new, narrower scope.
Jun 1, 2005

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.

Qualification of Network Components and Validation of Networked Systems, Part I

Oct 2, 2001

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

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