Should a Tester sign each step? This is one of the questions that the industry has been pondering for a long time. This is a mandatory requirement for testing in some healthcare companies but not in others.

This again imposes an overhead on testing and the question must be answered on a case-by-case basis by considering the following points:

• What is the GxP criticality of the test? Systems or functions with a low GxP criticality may
  justifiably demand a lower level of signed corroboration.
• What is the purpose of the step? If the step is required in order to set up the system for
  subsequent steps that actually demonstrate the test objective, a signature may not be
  required for the set up step or steps. This is especially the case where the correct set-up is
  clearly demonstrated by evidence such as a screen shot or where a witness observes the setup
  prior to executing the key step.

Where there is doubt about the requirement to provide a full signature, a step may be initialled as a compromise measure.Regardless of which steps are signed (or initialled) by the tester, the completed test must always be signed off and the context of the signature must always be clear. An example of such a statement could be:

Signed to confirm that all of the above test steps were conducted in a contiguous manner, in
accordance with the test instructions for each step and that the recorded results are an accurate
record of the test execution.

The Test Script should also include a clear statement of whether the test objective was met or not and whether the test was passed.

The Use of Test Witnesses

Given the potential GxP impact of testing, it is important that test results cannot be falsified. To
meet the expectations of certain of the Regulatory authorities this includes taking adequate steps
to ensure that test records cannot be falsified.

This may be achieved by attaching test evidence or by the use of Test Witnesses. The use of Test Witnesses should be decided upon on a pragmatic basis since the use of a witness adds to the cost of testing and often slows down the testing process.

The guiding principle should be that for GxP critical tests, where no adequate proof of testing can be obtained by other means, a Test Witness will be required to ensure that the Test Objective has been met.

For some tests this may require that the witness observes every step. This is likely where the test is designed to demonstrate a sequence of events, such as a functional work flow. In this case the witness must observe every step. Signing each step is not mandatory so long as the Witness signs at the completion of the test.

This signature should include a statement that the context of the signature is such that the Witness has observed every step and concurs that the recorded results and/or evidence and any comments or notes that the Tester has made are an accurate record of the test run. Unless such a statement is included, it will be necessary for the Witness to sign every step.

For other tests, where the initial test steps are only required to set up data or to place the system in a specific state to prove the test objective, it may not be necessary for the Witness to observe all of the preliminary set-up steps. In this case the Witness may observe and sign at the specific test step that proves the test objective or may sign at the completion of the test, with a suitable statement as to the context of the signature.

Understanding

A Test Witness must always understand what he/she is observing and must understand the objective of the test. This may require adequate knowledge of the system or application under test and may require prior training or briefing.

If a Test Witness does not understand the purpose of the test or any specific step, he/she should seek clarification before that test or step proceeds. If he/she is not happy that he/she has understood the objective of the test, if he/she is unsure whether the test objective has been met, or if he/she believes that the test was not properly conducted, he/she should either refuse to sign or more properly raise a Test Anomaly to review the situation.

The use of Test Witnesses may also be required for contractual reasons, where a User wishes to ensure that the Functional Testing does adequately prove that the system meets its business needs.

Conclusion

Decide upfront the how the signatures will be associated with your test cases, perhaps analysis each test script before execution and pinpoint what tests are GxP critical and what tests are not. This determination will lead you to better understand what exact test steps need to be signed either by the person executing or if an additional witness signature is warranted.