What is Validation?
Confirmation by examination and provision of objective evidence that software specification confirm to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.
Why Systems Need To Be Validated?
- Reduces risk and legal liability.
- Having the evidence that computer systems are correct for their purpose and operating properly represents a good business practice
- FDA regulations mandate the need to perform Computer System Validation and these regulations have the impact of law.