Priced at only $100, this information-packed book comes with a money-back guarantee if you don’t find at least one resolution to a troubling Computer Validation problem.

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Don't Make the Same Mistakes:

QA Edge, Inc. feels every individual involved in Computer Validation would greatly benefit from reading this fact-filled compilation of templates, case studies, suggested verbiage and, as the title suggests, errors currently being made. We’re so impressed, each consultant within our firm has received a copy and we have designated a portion of our web site for its promotion.

Here, finally, is a candid discussion of the Computer Validation mistakes repeatedly being made in the Pharmaceutical, Clinical Trials, and Medical Device industries. Based on the author's eyewitness accounts of ill-conceived tactics currently in use within these industries, this book is as interesting to read as it is informative.

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YOU WILL DISCOVER:

  • 100 Common Mistakes that cost you time, money, aggravation and regulatory actions.
  • How to avoid these mistakes and what to do if you've already made them.
  • Faster, easier ways of tackling such monumental problems as No Specifications, Insufficient Testing on an Existing Validation, Noncompliant Validation Documentation, etc.
  • Explicit answers and examples for your legacy systems
  • Loads of case studies, templates and suggested verbiage including actual excerpts from Corrective Actions
  • Great timesaving shortcuts that save you money while ensuring the compliance of your validation effort.

This book is the definitive resource on what NOT to do in your Computer Validation efforts and how to FIX IT if it’s too late!

QA Edge's GUARANTEE:

If you don't find at least one resolution to a troubling Computer Validation problem in this book, return it to us and we will refund the full purchase price of the book, no questions asked.

THE “TOP 15” REASONS FOR PURCHASING THIS BOOK:

  1. Do you know what FDA’s (unwritten) Big-Three Critical Requirements are that can cause a system to instantly fail validation? Page 188
  2. Do you know how to mitigate your risk when, after reading this book, you discover that your current validation effort is woefully out of compliance? Page 114 & 176.
  3. Do you know why the justification “the system is in widespread use” is unacceptable? Page 79
  4. Do you know the five most common mistakes found in the software OQ?  Page 104.
  5. Do you know exactly what is required for a COTS (configurable-off-the-shelf) validation? Page 207
  6. Do you know what needs to be done if your computer system fails validation? Page 108
  7. Want to know a time-tested method of bringing a noncompliant validation into compliance quickly? Page 113
  8. Want to know a simple, easy test for determining if a field or function is cGXP-related, and therefore needs to be validated? Page 133
  9. Want to know a quick trick to greatly increase your efficiency and speed of testing through intelligent test data selection? Page 139
  10. Do you want to know two causes of numerous 483’s given for inadequate computer validations? Page 143.
  11. Want to know the “Magic Number” that answers the question, “How much testing is enough?” Page 152
  12. Want to know ahead of time where the vast majority of deviations will be found during validation execution so you can pull in extra help to prevent schedule slippage?  Page 153
  13. Want to know a great tool that will quickly provide a gross assessment of your system’s readiness for validation?  Page 161
  14. Want to know how to effectively tap into your own onsite resources to get the best tests designed quickly? Page 161-162
  15. Do you know where a knowledgeable auditor goes first to “take the pulse” of an entire validation effort in just minutes? Page 197

CONTACT US:

Please contact us for more information, Natalia.Gelishvili@qaedge.com, or call Natalia at 800-459-3363

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Computer Compliance Made Easy