TABLE OF CONTENTS Remember that the terminology used here is derived from IEEE software engineering standards; in your organisation similar documents may be called something else.
From the discussion in section there is a Section 14.4 on PQ testing; there were a number of criteria for testing such as:
Test procedure steps
Expected results
Observed results
Acceptance criteria
Documented evidence
A test procedure should consist of three main elements:
Test steps and expected results (defined and approved before testing starts); observed results, note log, pass-fail statement and who performed the testing (written contemporaneously as the testing is conducted).
Documented evidence (not specifically required by the IEEE standards but essential for collating information used to support the testing for QA and regulatory inspectors review).
Acceptance criteria; these must be explicitly stated and not implied as they are in many qualification documents.
I am often asked questions about how much detail needs to be put into the test execution instructions? This depends on your company approach to risk and the amount of effort they wish to expand. From my perspective, the test steps should be written for a trained user and not a novice to execute. This saves writing the embarrassing series of instructions starting with, for example, sit in front of the workstation, press the on button and wait for the operating system to boot
Therefore, write the instructions so that a trained user can...
