10. How is this practical ? The cost of any request for change increases as you near “Go-Live” date. (from Boehm, Barry W. Software Engineering Economics . Englewood Cliffs, NJ: Prentice-Hall, 1981) 0 10 20 30 40 50 60 70 Requirements Design Code Development Testing Acceptance Testing Operation Development Phase Cost/Effort to Correct a Problem
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12. The importance of Computer Systems To the business processes. In the last 20 years, the number of previously manual GxP and business processes now computer controlled has increased dramatically.
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21. Maintaining The Validated State The Business Environment Changes. You Cannot Assume That Just Because the System Was Validated Last Year That It Is Still In a Validated State… ( A continual process ) Remember, Validation Includes Both System and Process!!!