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Designing A Validation Package For Quality Assurance

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5.1. Validation Documentation

5.1.1. Create a validation package consisting of:

· Q-FRM12699 Verification of Computerized Calculations

· Documentation produced from testing (evidence that the requirements of Section 5.3, 5.3, and 5.4 of this procedure have been met)

5.1.2. All phases of the validation will be approved by Quality Assurance. Laboratory management will assign a qualified person(s) to serve as Validator.

5.1.3. The validation will be assigned a title and version (e.g. 3-Nitro Result Calculator, Version 1.0).

5.1.4. The software name and version will be documented, along with the software’s minimum system requirements.

5.1.5. Once validated, the application can be used on any computer …show more content…

After normal fuction testing results have been verified, challenge tests (if any) will then be performed. The validation report will include the steps taken in the procedure as well as hard copies showing both the entry data and the calculated results. Choose data sets based on the number and types of criteria. Each calculation/macro argument or condition, with its expected outcome, must be tested for accuracy.

5.3. Normal Function Testing

5.3.1. Prior to testing, spreadsheet will be protected or otherwise secured to prevent changes to the application’s calculations.

5.3.2. Data sets will be entered into the application to evaluate normal function testing. Data sets will contain numbers covering the range of normal values.

5.3.3. The Validator will print the results and compare to previously calculated or known results. If the application does not have the ability to print, screen captures may be collected and pasted into a printable document.

5.3.4. A copy of previously calculated or known results will also be included as part of the Validation Report.

5.3.5. In cases where unexpected output is generated, the spreadsheet developer must revise the calculation or macro in question. This function is then revalidated. The process is repeated until the calculation or macro works as expected.

5.3.6.

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