14.3 PQ Test Plan

There are a number of ways to document PQ testing; the method that I use which is based on Institute of Electronic and Electrical Engineers (IEEE) software engineering standards and the documentation is derived from IEEE standard 829 entitled Software Test Documentation .65 However, there are other ways to approach the problem and you can also use other test plans and protocols. The bottom line is that you must ensure that the testing is documented and covers how you will use the system. IEEE standard 829 lists the main sections of a test plan, shown in Table 16; I use a slight modification of this when I write PQ test plans as not all sections need to be used for a CDS validation.

Once the system to be tested is defined there are three key sections that we will consider in more detail in this chapter:

• Features to test: Identifying the test scripts, the features tested in each test script and the requirements tested-traced from the URS. An example of this is shown in Table 17.

  Table 17: Linking requirements to testing in a PQ test plan