Course Code: ELM-119-02

Top Tips When Retesting Software in a Regulated Environment [Video]

Risk assessment gives you a good idea what to re-test.

But what is sufficient?

Before launching the re-test effort, take a step back and re-read the VMP.

Make sure that you’re staying compliant with what the master plan says.

Then, update the validation plan for the system.

This will:

  • Lay out what tests you plan to execute for the re-test.
  • Provide the rationale from the risk analysis for the scope of the retest.

In most cases, not all tests in the validation suite will need to be re-run.

For example:

If the change is isolated to a user interface screen (a text box went from 10 characters long to 20 characters), you likely don’t need to re- run IQ.

Consider the back-end consequences, however, because it’s possible that such a change fills up a database faster, so be sure to look at the big picture.

As mentioned previously, a well-structured test suite facilitates isolating the testing to a limited scope.

Another example:

If you have a user interface (UI) protocol and only the UI changed, it may be possible to limit testing to just the UI protocol.

If, however, you scatter UI tests throughout the functional tests, it may not be possible to test the UI in isolation and, depending on the change, may require all tests to be executed.

Author

Don Hurd

Practical Quality & Thorough Validation The Realtime Group