Validation Books

Francis Maguire's book is the best I've read on taking care of your employees. It makes all the sense in the world to treat employees like they're the greatest. And Maguire artfully and eloquently does this through examples and applications. He shows how validating employees is how wise managers conduct their daily routine.
I have learned much. Thank you Frank!
I heartily recommend this book!

Wow! How refreshing to meet someone who actually promotes the philosophy that more can be gained by a kind word than with a stern look. In this "Get Over It!" society it is nice to know that someone realizes the benefits of validation and even documents how it can produce profit. Told in a sort of biography of the life of Francis X. Maguire we follow him from his positions at major television networks, top U.S. corporations, and even the White House. With each step he has left his indelible mark on all those around him. He is responsible for guiding the careers of Ted Koppel and Charles Osgood as well as helping major companies such as FedEx and Kentucky Fried Chicken build their company policies towards employees. How wonderful if every company had a man like this encouraging employee performance with validation and a kind word. He is too good to believe!

While everyone has heard about giant companies such as Wal-Mart and General Motors, Fortune magazine occasionally runs articles about huge companies that most people don't know of. Similarly, in the information security space, many people have heard of regulations such as Common Criteria, ISO-17799 and HIPAA. Yet there is a huge regulation that many people know nothing of, namely 21 CFR Part 11.

Title 21 Part 11 of the U.S. Code of Federal Regulations (also known as 21 CFR Part 11 or simply Part 11) falls under the authority of the United States Food and Drug Administration (FDA). The FDA felt that the risks of falsification, misinterpretation and change without leaving evidence are higher with electronic records than paper records and therefore specific controls are required.

Part 11 deals with the conditions under which the FDA will accept electronic records and electronic signatures as equivalent to paper records and handwritten signatures and electronic New Drug Application (NDA) submissions as equivalent to paper submission.

With that, 21 CFR Part 11: Complete Guide to International Computer Validation is a very good overview of the topic.

The book details how organizations regulated by Part 11 can create a compliance strategy for validated systems.

Anyone needing a quick introduction to Part 11 will find this work valuable.

The only negative to this book is its price; at $180.00, it is extremely expensive. Such a price will make the book unobtainable for most readers. I believe its low Amazon.com Sales Rank of 1,810,979 is due directly to that.

This is a very useful, advanced references for HR professionals or I/O Psychologists struggling with some of the stickier issues concerning validating predictors. Particular strengths include chapters on job component validity, content validation, and banding. Many of the points raised in the book are particularly relevant for small business situtations, and readings from it might be very useful for an advanced class or seminar on HR in small business contexts. However, the authors assume that their readers are quite familiar with test validity and job relatedness, and readers without a background on these topics should start with a strong introductory text, such as Ployhart et al.'s
"Staffing Organizations" or a similar book.

Bible. Mentor. "Boiled down to essence" guidance. Old warrior sitting at the front, explaining all to new recruits. Facing a new occupational subject, I want a bible, a mentor, a guide. Get it down to "do"s and "don't"s; straightforward, to the point. In the struggles of achieving regulatory validation, Tamara Follet is sensei, mentor; her book my bible.

For newbies, this is a well-worn path. For those tried and true, dye-in-the-wool validation experts, a reclamation. For those who skirt the law, doing little, or nothing, this is the "book of failings" kept on high. We are all here.

Tamara bluntly points out mistakes and excuses typically made. The book reads "Face it. Whatever excuse you give is going to be insufficient. ... The only reason you are getting away with it is that you haven't been caught yet." Throughout, her examples have the feel of surviving the tests of time, like a video game, each area with challenges, mistakes, but always with a way to succeed and continue on.

Best was Verification Testing, "Test Script Generation Errors". It focuses on requirements of objective evidence, how to layout script formats preventing "pass-fail" results mistakes, explaining the whys. Alone it's well worth the purchase price.

With detail always at an appropriate level, Tamara even wades into the sticky arena of insufficient validation, recommending "Validation Addendums" as corrective action documents.

In Tamara's preface she clearly sets the attitude in her dojo:
"Let me apologize at the outset .... I am far too aged and cynical to approach this topic with any semblance of discretion. ... I am frequently cuttingly blunt, sometimes far worse. ... I've been in this field far long enough to have become jaded by the premeditated non-compliances I've seen all these years. ... Enjoy and learn from other's mistakes!"

This should be required reading for anyone who designs interfaces. If users are having a hard time using your software then you need this book. Great conversational style with well thought out content and screen shots. I wish I had this book earlier in my career.

Really a very well organized manual. Very helpfull both for new labs and labs that should be in compliance with the regulatory requirements.

This book bascially takes you through day 1 of drug manufacturing all the way to the end, when you have deal with regulatory. It also discusses analytical methods which was of great interest to me. Highly recommended for anyone who wants to learn more about this field.

Independent Verification and Validation (IV&V): A Life Cycle Engineering Process for Quality Software is the most advantageous weapon a software developer or software-related company can be armed with to minimize risk. Lewis' book takes a building block approach of what software development is and then breaks each software development life cycle (SDLC) phase down in detail. It discussions all functions of the SDLC, configuration management, quality assurance, and the differences betweeen them and IV&V...

John A. Sonquist is one of the few sociologists whose philosophy of science is not romanticist. This book is based on his Ph.D. dissertation written at the University of Chicago in 1963 - before the arrival at Chicago of Edward O. Laumann, a Harvard graduate from the Parsons era.

The book sets forth an accessible description of his computerized artificial-intelligence discovery system for analysis of cross-sectional data. The system is named AID, which means "Automated Interaction Detection". Contemporary academic philosophers of science would recognize and applaud his pragmatism in his using data analysis for discovery instead of some romantic idea such as Weber's verstehen.

Unlike most artificial-intelligence designers such as Herbert Simon and Paul Thagard, Sonquist did not seek to model the human mind or contribute to cognitive psychology. His aim was much more pragmatic: to mechanize the computational and decision procedures that social scientists actually use to analyze cross-sectional data. By mechanizing procedures already known to be fruitful he designed a system that is now widely used commercially for market analysis and risk analysis. It is the strategy I have preferred for my own Metamodel discovery system for longitudinal time-series data, which I developed in the early 1970's. See my book History of Twentieth-Century Philosophy of Science, my com web site philsci, and my other book reviews.

Such computerized analysis for discovery is also called "data mining". It works! My system has enabled my success for thirty years as a research econometrician. And Sonquist's AID system has enabled many data-mining users to strike gold, both information-wise and money-wise. Today commercial versions can be found in SAS and SPSS proprietary software utilities, and the design is described in textbooks for market research. I have found very few businesses that do not routinely use it today. This is a historic book worth its weight in gold.

Readers are invited to Google my book History of Twentieth-Century Philosophy of Science at my web site philsci with free downloads by chapter.

Thomas J. Hickey, Econometrician

3. Gibbon's Decline and Fall....
2. King James Bible
1. Pharmeceutical Process Validation-Chapter 1