Unit Testing for CSV

The following is a chart I produced to coach developers on the flow of test case development, approval, and execution for computerized systems validation (CSV) of software intended for use in medical devices. For entry into HPQC as the tracking and approval system, the green flow depicts developer tasks and the blue tasks represents check points for the verification and validation (V&V) team.

Unit Test Flow (CSV)

Following this plan with a team of seven developers I fully documented over one hundred eighty unit test cases of an automated medical diagnostics device for submission to regulators. The project took a little under six weeks with an original project estimate of eight weeks effort. The development team were used to Agile software development methodologies and as the independent V&V member of the scrum I presented the plan as a two-sprint role-reversal where I would develop SQL to get the test reports out of Quality Center, and they would be spending their time designing, documenting, and delivering test cases.

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