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Verification & Validation
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Verification
"The process of evaluating a system or component to determine whether the products of a given development phase satisfy the conditions imposed at the start of that phase." [IEEE Standard 610.12, and this definition is recognized by FDA]
- This is a phase-to-phase development activity, but may be performed after-the-fact as a "retrospective"
Validation
"The process of evaluating a system or component during or at the end of the development process to determine whether it satisfies specified requirements." [IEEE Standard 610.12, and this definition is recognized by FDA]
- This is often performed during the O&M phase of development.
Validations We Perform
- Product Validations
- Process Validations
- Computer-Based System Validations
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