Design spreadsheet validation

The tests should be repeated thereafter at regular or nonregular intervals. Therefore, any test case should be designed for reuse using sets of data inputs and known outputs. If the program is used infrequently, it is good practice to run the tests each time the program is used. Spreadsheet validation is discussed in detail in Chapter 18 and in Ref. [11]. 

It is important to note that, although the tables of experimental designs in this chapter show an orderly progression of experimental conditions, when the experiments are done, the order must be randomized. A random order can be generated in a spreadsheet, or if statistical or validation software is used, the program might randomize the order. Randomizing the order of experiments is the best way to confound uncontrolled effects and should always be employed. 

The spreadsheet will be used in department/group/area ABC. The spreadsheet will be used after successful validation (or the spreadsheet is in use since [DATE], if validation is performed retrospectively). John Doe developed the spreadsheet. Jim Doe will perform the validation. Validation will include items... [define which sections (e.g., requirements, design, tests) will be applicable to the validation]. 

Validation requirements in addition to Class 3 spreadsheets exist for Class 4 spreadsheets. These additional activities can be divided into planning, design, testing, and reporting. 

Brainstorming sessions for process flow charts typically name 25 to 30 factors believed to have some effect on the outcome. However, the Pareto concept of the vital few and trivial many, also called the 80/20 rule, indicates that usually not more than seven, and often five or less, factors are truly significant and vitally important. Chapman notes this as well A [validation certificate] is promulgated for each operating parameter range designated as critical in the control spreadsheet most pharmaceutical processes require about five to 10 certificates (35). 

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