Example Validation.xlt was designed to provide an example of validation documentation produced by Ofni Systems. Users enter pairs of mass vs. volume data points. The spreadsheet calculates the maximum, minimum, and average value of volume. The spreadsheet also calculates the volume squared and charts mass vs. volume and mass vs. volume squared. Three validation documents are available: the functional specification, design specification, and executed test protocol.
A validation package will typically include additional documentation, including a validation plan, requirements traceability matrix, and validation summary report.
This example validation package is offered as an educational tool to demonstrate sample validation documents generated using Ofni Systems validation methods. The documents were created by Ofni Systems, and any use of the documentation should acknowledge the original authorship of the documents.
Maintaining a compliant state for any system requires a series of procedures and controls, which are referenced in the documentation. The requirements documentation and level of testing described in the protocol are appropriate for this system; systems with additional complexity would require additionally complex requirements documentation and rigorous test protocols.
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