Fundamentals Elements of Computer Validation:
- Document validation plan and procedures.
- Establish acceptance criteria (i.e. parameters, limits and ranges of components).
- Demonstrate equipment systems are calibrated and operate properly.
- Demonstrate that the process meets an established range of operation for multiple runs.
- Demonstrate that the final result of the computer process meets pre-determined characteristics.
- Demonstrate the longevity of the equipment or process performance by challenging the equipment/process at the limits of operating conditions for multiple runs.
- Demonstrate the accuracy and precision of any test method.
- Demonstrate that the validation work has been performed as planned and the outcome meets pre-determined specifications and the validation work has been documented, reviewed, and approved.
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