Validation Books

The book was godd, but like alll the Validation/Verification books on the market... it never hits the points that are really needed to make 'your' process successful.

Although I did think that overall it is a good guide.

Este es un libro eminentemente práctico sobre "Ingeniería del Software".

A diferencia de otros libros, excesivamente llenos de ejemplos (normalmente de las malas prácticas), éste se centra en describir las diferentes aproximaciones para todas las etapas de desarrollo del software. Aunque se decanta por el modelo de desarrollo "Waterfall", explica otros modelos de desarrollo.

Un elemento a destacar de este libro es la calidad de los apéndices que incluyen numerosas plantillas de ejemplo para cada una de las etapas de desarrollo, y en especial para los procesos de inspección, y seguimiento de los errores.

Otro aspectos que se cubren éxito en este libro son los dedicados a la estimación de esfuerzos para la planificación, estimación de riesgo que en casi ningún libro de ingeniería del software ofrece alternativas tan interesantes como en este.

A modo de ejemplo, los apéndices que incluye son los siguientes:
- Inspection Roles and Responsibilities
- A Sample Inspection Process
- Inspection Process Forms
- Inspection Checklist
- Attributes of Good Requirements Specifications
- Sample Criteria for Selecting Modules for Code Inspection
- Sample Software Development Process Based on the Waterfall Model.
- Document Outlines
- Test Cases for the Triangle Program (example)
- Software Reliability Models.
- The Yellow Sticky Method
- Software Development Best Practices
- Software Quality Best Practices
- Project Postmortems
- Root-Cause Analysis

Finalmente el autor mantiene una página Web asociada al libro: http://www.swqual.com/index.html?Intro.
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Carlos Ortega
2006-01-30

Bill Gates is famous for his yearly retreats where he takes
a pile of books and reads them. Maybe that's the one thing
today's managers should emulate. If you do, bring this book
along on your first sabatical.

This all new edition of the book (first published in 1997)
was even renamed to include its new, extended charter.
"Clearly management must take a leadership role in helping
the organization behave in a more predictable way. It is
for this reason that the title of the book has been changed
to include managers. [the book] includes specific actions
that managers can take to help organizations behave in a
more predictable manner."

Software development is a difficult disciple to master.
Even so, technical acumen is no guarantee of quality. "As
observed by Dr. Edwards Deming, 'The quality of a product
is directly related to the quality of the process used to
create it.'" Verification ("are we building the product
right?") and validation ("are we building the right product?")
are the first questions one must ask to begin the path
of process improvement. This book addresses those questions
and more.

The book is divided into four large sections. The first
three sections are brought forward from the previous
edition with some noticeable improvements. The new edition
is not just a rehash of the old stuff, however. Over 30 new
pages of appendices and an entire new section of the book
aimed at management with over 70 new pages have been added.
Other improvements are also evident including better formatting.
For example, the font selection and layout are much easier on
the eyes than in the previous edition.

If you own the first edition, this is a "must have" update.
If you don't own the first edition, consider this work an
SQA department "starter kit." It is well organized, well
annotated, and filled with practical artifacts such as
checklists for inspections, suggested document outlines,
and the like. This is stuff you can use.

Chapter 12 is specifically for the CEO and should be
required reading by anyone running a company with a
software development function. "Managers and executives
need to understand that having a predictable software
development process is vitally important to the long-term
success of their business." Rakitin shows how, then shows
what can be done. The prose is crisp and to-the-point.
Well done.

Good by all segments of Basel II risk components. Especially on EAD, LGD and partly on retail the domains not so frequently worked out in other similar book. Perhaps some more effort on retail, concentrationa and economic capital. But that could be a new book allready. Stress test domain is good example.

For anyone who needs to learn the financial philosophy and mathematical formalism behind the Basel II accords, this book will be an excellent introduction. Consisting of a collection of articles written competently and concisely, the book should be on the shelf of those who are not only responsible for implementing the Basel II accords but also work in the trenches on how to validate it with respect to the banking institutions in which they are employed. The technical details behind the Basel II accords are straightforward to understand mathematically, but the accords can be delicate to implement from a data collection standpoint. However the latter is not addressed in this book, with emphasis primarily given to the formalism and how to validate it in real situations.

Due to its mathematical rigor the chapter on PD validation by R. Rauhmeier is one of the more valuable ones in the book. It deals with mathematical methods for assessing the quality of estimates for PD, but gives examples from practical banking experience. Most interesting is that the author discusses how to compare rating systems developed by human experts with those that result from machines (algorithmic ratings with no human input). Along these lines, the author views a rating system as essentially a collection of modules, the first one of which is called a `machine rating' since it estimates the PD by an algorithm based on statistical models and not therefore dependent on human judgment (excluding the judgment of the developer of the algorithm of course). The machine rating is then subjected to expert opinion in the second module, wherein it is expected that the rating will be adjusted according to the judgments (and biases) of the (human) expert. The third module is also very standardized, and deals with the degree to which the borrower is supported by others when in financial distress. Any support structure that exists will of course influence the PD of the borrower. Manual overrides that arise because of exceptional situations are part of the fourth and final module. The author views the rating model as `default generating process' which is function of certain selected risk drivers, and is typically measured in terms of rating scales. He gives an example of a `master scale' in this chapter, with this one deploying a "point-in-time" rating approach.

Most of the chapter is devoted to finding PD validation methods that can test all the rating grades simultaneously. One of these is the Spiegelhalter test, which uses as a test statistic the ratio of the difference between the observed mean square error and the expected mean square and the square root of the variance of the mean square error. If the null hypothesis, namely that the forecasted and observed default probabilities are equal for every obligor, then this ratio is normally distributed and then standard techniques can be used. The Spiegelhalter test helps to remove the bias that exists in merely averaging the PDs of obligors in the same rating grade, but it does assume that the default events are independent. The assumption that the default events are independent can be dropped by using Monte Carlo simulations, and the author gives the reader a taste of how to do this in this chapter. As is typical in Monte Carlo simulations, random paths are generated in order to approximate the distribution of the test statistic. The author discusses an explicit simulation study using various choices of the asset correlation parameter, and it is clear that its value has a dramatic effect on the distribution of the test statistic. It would have been helpful if the author had expounded on how to calculate the value of the asset correlation parameter and discussed its connection with various credit risk models, such as the Merton model.

The last chapter of the book discusses stress testing, which the authors define as the study of risk characteristics to fictional perturbations or shocks. Stress testing is practiced widely in the financial industry, especially when sudden and dramatic losses occur in credit portfolios. These losses can surprise risk managers and create extreme skepticism towards the mathematical models used for forecasting. It follows of course that the Basel II accords would be interested in stress testing, but the authors of this chapter assert that they do not yet have the level of sophistication that one can find in the financial industry nor are they precise. The methods that the Basel II accords recommend are reviewed in this chapter. In this regard the authors point out that it is the probability of default (PD) that is the parameter of interest for stress testing, since the EAD and the LGD are relatively insensitive to radical events by their very definition. The PD is varied either by modifying rating grades or by modifying the PDs of the rating grades used for the stress test. The authors give an example of a stress test involving a very well-diversified "virtual" portfolio which shows the effects on regulatory and economic capital of various shocks, such as dramatic rises (and drops) in the oil price, recessions, and appreciative drops in the stock market index. Real portfolios they argue will exhibit even more dramatic effects, since they are not as diversified as this example. It would have been more helpful if the authors had included a more rigorous analysis, possibly one that uses Monte Carlo simulations or extreme value theory, but as applied to a practical situation that risk managers might encounter. One example might be the extreme losses that occurred in mortgage portfolios beginning in the third quarter of 2006. These losses took the risk community completely by surprise, and the forecasting models in place at the time, even though they underwent considerable stress testing before these losses began accelerating, were unable to predict them. The lesson to be learned from this example is that one must perform stress testing not with scenarios that may not have occurred in the past. The imagining of hypothetical scenarios that may shock a portfolio but that have never been realized in the past will be an important part of the future game of stress testing.

I wish I could count the times I've seen second and third rounds of development occur because the first round produced a working version of a product the customer didn't want. With all of the emphasis lately on rapid development, especially now that the web has everyone working on "internet time", there has been a noticeable lack of discussion on ensuring the software produced fits the needs of the customer and is of reasonable quality.

Rakitin addresses these issues and more in this book. As the title indicates, he concentrates on Verification ("are we building the product right?") and Validation ("are we building the right product?"). However, the subtitle to the work "A Practitioner's Guide" provides much more insight into the actual scope of this work. In the discussion of software inspection meetings, for example, Rakitin give guidelines regarding not only the mechanics of who should attend and when materials should be distributed but he also provides insight into what to expect as a moderator and how much should be expected to be accomplished in the meetings themselves. There are a number of statements in the book that begin "Experience has shown..." Rakitin's extensive experience has manifested itself throughout the book transforming the dry, checklist-like discussions found in so many other books into discussions about how people work and communicate with each other.

This isn't to say there couldn't be more. Although what's presented is very good, there are points in the book where I found myself wishing for additional discussion. Perhaps in future editions Rakitin will be able to expand upon, say, requirements collection or configuration management.

There are also things that could be updated if the book were to have a revision. For example, a brief discussion on OO methodologies is provided where Fusion from HP is outlined. This could obviously be expanded to cover the Rational Unified Process, Rational's effort to provide UML with "meat" the modeling language alone could not have.

As Deming observed and Rakitin noted, "The quality of a product is directly related to the quality of the process used to create it." To this end, Rakitin attempts to provide the reader with ready-made tools, checklists, outlines, and forms to aid them in the maturation of their software engineering department. These items, which appear in approximately 80 pages of appendices, give the reader a variety of starting places for just such an initiative.

Brooks said "no silver bullet" and he was right. Quality software is possible only through a methodical, rational, and scientific approach. Rakitin goes a long way towards that in this work. I highly recommend it.

Software Verification and Validation by Steven R. Rakitin. A practical book by a practical author, presenting the steps required to set up a formal and complete Verification and Validation program for software production. Mr. Rakitin sprinkles pertinent quotations throughout the book to support his case that software quality programs (detection) cost less than simply releasing a "buggy" program to your Customers. The author also teaches the lessons of this book at IEEE lectures; I attended one in March 1998. At these lectures, the author fleshes out and makes more interesting many of the points made in his book. As an ASQ Certified Software Engineer, S. Rakitin has the credentials to expound on many aspects of quality programs set up to deal effectively with the major & crucial issue of the lack of software quality today. There are 169 pages of text, describing a good program, but the author has also included some 87 pages of appendices (from "A" to "H") which give you a cook book or recipe approach to different aspects of software quality. The author gives you good leads to other sources of information on software quality. The book would profit from another good editorial review, reducing the wordiness in some chapters and tying the whole story all together. For example, Rakitin continuously uses "SEI" which (as far as I can see) is not defined in his book. SEI = Software Engineering Institute. In Chapter 4, the author attempts to establish a cost/benefit justification for implementing a software quality program, but misses and then, later, on page 90 (Chapter 7), he DOES lists the pertinent reasons as, "...lower support costs, ... fewer maintenance releases, ... higher customer satisfaction and, as a result, increased sales". An astute editor would have melded all of this together. Overall, this book is directed at the practitioner, whether a hardware quality engineer required to set up a software quality program, or a novice who has the same task. It is a practical book, generally well written,

This book covers a wide variety of topics related to employee selection: adverse impact, test validation, job analysis, structured interviews, setting cutoff scores, and establishing training and education requirements. The book is a great reference for practitioners who want to get the "big picture" about setting up a state-of-the-art selection system. Probably the greatest strength of the book is the discussion of adverse impact. The author provides some background and insight on this topic that is not found in other books. What would improve this book? More detail on each of the topics. But, overall, well written and useful.

The book covers the basics of verification and validation of CFD simulations. It is not an advanced text for scientists, but an introductory text for beginners or CFD engineers. It is divided into 5 chapters, with a solid background presentation in chapter 1, followed by a description of the terminology (chapter 2). In the rest of the book, the author divides the subject into verification (grid and time step sizes tests) and validation (comparasion with previous or experimental data), presenting good descriptions of both itens.

This well-written and cogen book is an excellent review for life scientists interested in getting an up-to-date overview of issues pertaining to the computational analysis of potential drug targets. The book addresses a wide selection of issues, ranging from sequence and microarray to hardware requirements and system design. Chapter 5 (on microarray analysis) is a particularly cogent and level-headed discussion of the pitfalls of microarray gene expression analysis.

Massimi covers both theoretical physics and philosophy in this book. In doing so, a physicist reader might well find herself treading water in parts of the text. If you thought you knew the Pauli Exclusion Principle, by the time you finish the book, you might be befuddled.

It's simply that Massimi looks at the Principle and its history in ways unfamiliar to most physicists. Not that he is wrong, but that the logic and terminology he uses are their own speciality. The pure physics parts of the book are straightforward to follow, and should be safe grounds for such readers.

This book was really great at leading you to certain aspects of Validation and some of the basis. However, like all other books on this subject matter, it is still lacking in the real 'MEAT' of this process and what FDA auditors and others may be looking for in your processes.

I found this book to be a great initial guide, but wish it had some more to it... about what the title refers to.

Reading this book was painful for me. This is coming from a reader of the English version. The idea of this story could have been good, a chase to save a forbidden treasure from a greedy man with a lot of wealth, but I did not find it at all interesting.

I can understand why this author is well liked, some parts of the book were well thought out and described. The problem was that the main story was not well planned out. All of the story fit together awkwardly and made it uninteresting to read.

Mystery and fantasy are not a category that I believe should be written by this author. The magic in this story seemed to far-fetched and too all-powerful to make it fun. Although some may have been interested to find out who the villain was, I thought that it was painstakingly obvious from the moment the character appeared. If you never have read a good mystery novel in your life, you may be fooled.

I have read books that were translated into English before and I understand that some of the creativity may have been lost. I think one star is appropriate for the book since I do not understand how the amount of creativity this story lacks could have been lost in translation. If the story is lost in the translation, I feel that is should not have been translated in the first place.

Kingdom of the Golden Dragon by Isabel Allende is very interesting. The plot had many twists and turns that really spice it up. How the plot weaves together and who the bad guy really is was awesome! How the Golden Dragon really works is brilliant! All of the settings, from India, to The Kingdom of the Golden Dragon was interesting. The author portrays the love and compassion of the Nepalese people that they show for each other. She also shows how they can be cruelly exploited. This among the best children's books I have ever read. By JJ

I loved this book on tape and its two companion stories. I've always been a fan of Isabel Allende and listened to Daughter of Fortune and Portrait in Sepia in the car. Then Id purchased Kingdom of the Golden Dragon and the the two other books in this series on tape. I really enjoyed them although they are very different from Allende's other books. I imagine that a 10-13 year old child would really enjoy these books and have set them aside to give as a gift to a special young person in the future. Despite the more simple story line I loved the tapes and couldn't wait to get back in the car to listen. Books-on-tape are, I think, the complete answer to road rage. When I'm listening to something good I don't care how long it takes to get where I'm going.

I enjoyed reading this book because of Isabel Allende's ability to recreate and capture the desolate and harsh environment of the Himalayas. This is present at the beginning when the two Monks are traveling about the mountains and discover the Yetis for the first time. I also liked the idea of having the protagonists evolve in terms of their courage and attitude towards protecting the statue. This is important because you should always fight for what you believe in and sometimes making the decision to go on is difficult, but in the end, it can make a huge difference.One of the few things that I disliked about this book is that sometimes the story moves at a slow pace and the plot becomes predictable to the reader. Overall, I would highly recommend this book.

Only after I finished this book did I realize it was for young adults! (My reaction before I found out was that Allende had gone seriously downhill.) But from the young adult perspective, it's not a bad read. The second of three mystery/travel/adventure books by Allende, written for her grandchildren, this is an entertaining tale set in a thinly disguised Bhutan. An irascible, mid-60's-ish travel writer named Kate Gold invites her grandson and his friend Nadia from South America to join her on a trip to the Himalayan Kingdom of the Golden Dragon. There they meet up with the King and his heir, a seven-foot tall monk trained in the martial arts, the secret Sect of the Scorpion, a plot to steal the Kingdom's most valuable treasure, etc. No sex, not much violence, and lots of traditional values. Probably good for the 12-13 year old set, but, unlike Harry Potter, definitely not for grownups.

This book is a very good basic (and comparatively inexpensive) introduction to the terms and definitions of method validation. Certainly worth the price until the next edition comes out in early 2007.
Protocol sugestions, and the bibliography are worth the price alone.

I have to admit being a bit disappointed with this book. The content is sound, based to a large extent on ICH guidance, and for the most part, applies concepts to HPLC analysis. The actual text begins on p17 and ends on p 83, with an average words/page <250 (there are likely less than 16000 words in the entire text). So my rating is biased by what I consider a poor value in terms of cost/content. By way of comparison, the ICH Q2A and Q2B comprise almost 3700 words.

Although the book focuses on HPLC, the title concept also applies to other analytical methods (immunoassays, bioassays, mass spec., flow cytometry, etc.) There is clearly more to be learned on this topic. This text may be considered an intorductory primer, or a concise summary.

In retrospect, I would preferred to have spent more money to receive a more thorough text with applications in more diverse methods.

Very general description of the method validation process. This book could only be the first step in undestanding of the general requirements for the method validation process. To deepen one's knowledge, the reader should choose the books (e.g. Development and Validation of Analytical Methods by Christopher Riley) which are focused on explaining the concept from the scientific prospective.