Library

Here there are PDF copies of many of the articles that I have written for various journals and magazines including: Questions of Quality column for LC-GC Europe, Validation and Verification column for Scientific Data Management, Focus on Quality: Spectroscopy and American Pharmaceutical Review.

Welcome to the www.rdmcdowall.com Library

Library articles are arranged vaguely by subject or topic. The library is free - please take your time to read on-line or you are welcome to download any files and read them offline at your leisure.

Writing articles is a way of developing my thoughts on a particular topic. As such they represent my thinking at the time an article was written - this may have changed between the time of writing and when you download the article for various reasons such as the changes in regulations etc.

I welcome comments and feedback on any of my articles; if you have any questions please use the Ask Bob page to e-mail me a question. Please do not expect an immediate answer as I may be travelling. I will do my best to respond to your question as quickly as possible.

Libraray Sections

Computerised System Validation
Information about the various stages of the system development life cycle (SDLC).
Electronic Records And Electronic Signatures (21 CFR 11)
Bob's thoughts on the Electronic Records And Electronic Signatures 21 CFR 11 regulation and its interpretation.
CSV Risk Management
Risk management in computer validation is a hot topic since 2003 and the publication of the FDA's Part 11 Scope and Application guidance for industry stated "we recommend that you base your approach on a justified and documented risk assessment".
IT Network And Infrastructure Qualification
This Library section covers the increasingly important area of regulatory compliance in the IT Departments of the pharmaceutical and other regulated industries.
Laboratory Information Management Systems (LIMS)
Some of Bob's articles on the subject of Laboratory Information Management Systems (LIMS). Bob is the 1997 LIMS Awardee from the LIMS Institute based in Pittsburgh, PA, USA. Bob also edited the first book on the subject in 1987.
Chromatography Data Systems (CDS)
Articles that discuss the selection and validation of chromatography data systems (CDS) in the regulated analytical laboratory.
Validation Of Spectrometry Software
Articles from my column called Focus on Quality from Spectroscopy magazine dealing with the validation of spectrometry software.
Designing And Implementing The Paperless Laboratory
Laboratories have to work electronically if they are to survive. Therefore the paperless laboratory is an imperative.
Analytical Equipment Qualification
Qualification of analytical equipment is a key regulatory compliance issue within regulated laboratories.
General Analytical Topics
Articles and book chapters written by Bob over a number of years.

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