NEED MORE REASONS? Do you know how to resolve these problematic Computer Validation issues? Do you know how to – quickly and cost-effectively – generate detailed specifications for your legacy system? Page 47 Want to know a practice you are probably already doing, that veritably screams to the FDA, “We’re hiding something!”  Page 198 Do you know EXACTLY what needs to be in a Requirements/Design Specification in order to avoid a 483? Page 42 Do you know what the FDA's "Mandatory Order of Test Execution" is? Page 175. Are you harboring unfounded confidence in the compliance status of your validated system? Page 224 Want to know the one secret that will enable your Auditors to discover the real weaknesses of your vendor BEFORE you buy their system and find out the hard way? Page 52 Want to know a great trick for creating a comprehensive Traceability Matrix without any extra effort? Page 122. Want to hear about a Change Control problem that caused a company to suddenly lose file transfer capabilities on a validated system? Page 59 Want to hear about a simple validation oversight that brought a newly validated system to its knees? Page 99 Do you know EXACTLY what the FDA expects to see in your Disaster Recovery Plan?  Page 61 Do you know what the two conditions are that mandate a full revalidation of your system? Page 70 Do you know what all the recent FDA "Hot-Buttons" are? Page 72 Do you know what two elements are required to ensure Test Step Repeatability?  Page 127 Do you know what all is required to be included in your Validation Plans? Page 87 Do you know what the five criteria for adequate Configuration Control are, regardless of whether your configuration management is manual or automated?  Page 74. Do you know why experienced vendors hate customized systems, even though they stand to profit from them more? Page 75 Do you know what configuration controls should be documented for a Custom System versus a COTS System? Page 76 Do you know what Data Conversion controls are required for a validated system? Page 79 Do you know what four items need to be recorded for non-validation testing? Page 82 Do you know how to correctly handle Retrospective Sign-offs? Page 86 Do you know what four items are almost always left out of Validation Plans? Page 89 Do you understand why all these seemingly arbitrary deliverables are required and how to adequately document them?  Purchase Orders – Page 93 & 99 Escrow Account – Page 56 User's Manuals – Page 101 Operating Environment – Page 101 Historical File of Software Revisions – Page 67 & 78 Do you know what 13 items are required in a Hardware IQ? Page  93 Do you know what 17 items are required in a Software IQ? Page 100 Do you know the 6 types of testing are required as part of the Software OQ? Page 106 Do you understand the different levels of documentation required for Unit, Integration, and Acceptance Test versus Validation Test?  Page 145 Do you know a quick, easy, and inexpensive way to ensure consistency in your test scripts, no matter how many people are working on the protocol?  Page 42 Do you know what three additional tests should always be included for Real-Time systems? Page 211 Do you know what eight items are required to demonstrate the system was developed in a controlled manner? Page 17 Do you know what seven items are required to prove that the system was implemented in a controlled manner? Page 18 Do you know what five items are required to demonstrate the system was tested in a controlled manner? Page 19 Do you know what six items are required to demonstrate the system was operated in a controlled manner? Page 19 Do you know what seven items are required to prove the system is maintained in a controlled manner? Page 20 Want to see a real Validation Final Report?  Page 109 Want a simple explanation for why the FDA is constantly tightening controls? Page 113 Want to know why it is a doomed approach to write test scripts based on the system, instead of based on the specifications? Page 117 Did you know that not only the actual calculation used, but the source of the calculation needs to be documented in your specifications?  Page 146 Do you understand why you need to test for "known" problems in your system? Do you know where to find a ready-made list of known problems? Page 149 Do you know the 12 kinds of Stress Testing necessary to demonstrate your system is fault-tolerant? Page 155 Want a test plan you can easily follow so that your Audit Trail testing isn't found inadequate by the FDA? Page 150 Want a test design for verifying Mutual Exclusivity, (an often overlooked but important test), in your validations?  Page 159 Want an easy workaround in the event your system does fail Mutual Exclusivity? Page 159 Want an outline for a quick training class that can be taught to your testers so that 90% of your documentation errors are eliminated? Page 164 Want to know how the FDA's requirement of "Independence of Review" is often misunderstood and improperly applied? Page 167 Want to see an actual Case Study where an inexperienced test script writer caused a 483? Page 169 Do you know what 13 items should be verified during the Pre-Approval phase of the Validation Protocol review process? Page 173 Do you know what six things should be verified during the Post-Execution review process? Page 174 Did you know that "Ad-Hoc Testing" during the validation effort is encouraged by the FDA?  Page 178 Want to see what compliant Deviation Form looks like? Page 183 Want to know how to fix poorly documented Deviation Records in an "old" validation effort without having to redo the whole validation? Page 184 Did you know that an astute inspector will expect to see system errors discovered during a validation effort? Page 192 Are your classifications of Deviations adequate? Page 195 Do your validation efforts show forward and backward Deviation Traceability? Page 184 Want some great timesaving, problem-avoiding, forms that can be made part of your validation right now? Pages 200 – 203 Do you know how to identify "Data-Dependent" errors versus "Situation Dependent" errors? Page 204 Do you know the regulatory view of "Ad-Hoc" Reports and a quick, easy solution for this perplexing issue?  Page 208 In the light of the new "narrower interpretation" of the Part 11 Guidance on what constitutes a system requiring validation, do you know what the next step is in evaluating your "Secondary Systems"?  Page 210 Want to know a quick trick to vastly improve the efficiency of your Risk Assessment Session? Page 217 Do you know of any other Computer Validation book that the distributor backs with a 100% money-back guarantee if you don't save at least the purchase price of the book, and perhaps exponentially more, by following the advice contained therein? QA Edge is so confident that you will be as impressed as we are with this book that we will give you your money back, no questions asked, if you are not satisfied with your purchase. ABOUT THE AUTHOR: Tamara Follett has an M.S. in Computer Science and over 20 years experience in all aspects of cGxP Computer Validation. As an Independent Consultant serving the Pharmaceutical, Clinical Trials and Medical Device Industries, she developed and executed many large-scale computer validations and re-validations, identifying such critical deviations as data loss and data corruption prior to the system going into production.  She has generated and maintained Master Plans, Validation Plans/IQ/OQ/PQ/Final Reports/Deviation Logs/Deliverable Lists, and other project documentation such as procedures, work instructions and guidelines.  She has developed comprehensive Life Cycle Documentation for numerous legacy and new systems, including Requirements, Specifications, Traceability Matrices, SOPs, Training/User Guides, and other SDLC deliverables, including: Needs Analysis, Vendor Gap Analysis, Risk Assessments, Disaster Recovery Plans, etc. Ms. Follett has conducted numerous Compliance Audits, Quality Audits and 21 CFR Part 11 Audits.  Considered to be a Subject Matter Expert in Computer Validation by Stat-A-Matrix, CSSC, and other validation industry leaders, she is a sought-after speaker and auditor. CONTACT US: Please contact us for more information, Natalia.Gelishvili@qaedge.com, or call Natalia at 800-459-3363 Purchase Online