Information from guidance documents used in clinical investigations can be very useful to help meet FDA regulations regarding computer security in analytical laboratories. Nov 1, 2007 By:
R.D McDowall
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Information from guidance documents used in clinical investigations can be very useful to help meet FDA regulations regarding computer security in analytical laboratories.

The sole purpose of some organizations is to serve as an example for others not to follow. In this article we will explore the FDA inspection of the Able Laboratories chromatography data system (CDS). Let's hope your laboratory and CDS are not this able! Mar 1, 2007 By:
R.D. McDowall
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Users need to understand not only the operation of the computer system as required by their access privileges, but also the ethics and integrity required operating under any of the GMP or GLP quality systems.

Guidance to help validation of computerized systems used within regulated laboratories is always welcome but is it always helpful? In the first part, I present an overview of the Guide, different approach to life cycle validation and system classification. May 1, 2006 By:
R.D. McDowall
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The best parts of the GAMP laboratory system GPG are the life cycle
models for both development and implementation of computerized
laboratory systems.

A Question of Balance? Part 2: Putting Principles into Practice Mar 1, 2006 By:
Chris Burgess, R.D. McDowall
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Part 2 of the column explores using the right balance for the right job in the right way.

Sep 1, 2005 By:
Jens Donath, R.D. McDowall
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The implementation and validation of a new site-wide chromatography data system for a major active pharmaceutical ingredient custom manufacturer provided the opportunity to map and optimize the GMP and ISO business processes to use electronic signatures effectively. This article describes the process optimization and how it integrates with the validation activities of the system. This overall approach provides substantial business benefits from the use of electronic signatures as evidenced by the savings resulting from process improvement and by the fact that the non-GMP laboratories implemented a similar process to analyse and approve results electronically.

by R.D. McDowall May 1, 2005
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Bob McDowall stresses the importance of using accurate and precise time and date stamps to ensure the integrity of the data and results generated by computerized systems in any chromatography laboratory.

by Robert D. McDowall Feb 1, 2004
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In the welcome return of this column, Bob McDowall revisits the evolving topic of 21 CFR 11 compliance, as it applies to chromatographers. He examines the FDA's activities in 2003 and outlines the current status of its regulations over, and guidance for, electronic records issues.

In this column, the benefits of implementing a compliant CDS for both electronic records and signatures are highlighted.

The importance of data back-up and recovery is stressed and suggestions given...
