Validation documentation for system testing, particularly for a failed test, must provide objective evidence of the failure. According to Good Clinical Data Management Practices (GCDMP) and established software validation principles (like GAMP 5), the core of any test execution record is the direct comparison between the pre-defined 'Expected Results' and the observed 'Actual Results'. A test fails when these two do not match. This documented discrepancy is the primary and essential information that proves the failure occurred and provides the basis for any subsequent investigation, such as a root cause analysis.

A. Training requirements: These are documented in the overall validation or training plan, not within the specific execution record of a failed test case.

C. Reconciliation datapoints: Data reconciliation is a separate data management activity to ensure data consistency across different sources, not a component of system functionality test documentation.

D. Root cause analysis of the system errors: This is a subsequent investigative step performed after a test failure has been documented. The initial documentation records the failure itself (expected vs. actual results).

1. Society for Clinical Data Management (SCDM). (2023). Good Clinical Data Management Practices (GCDMP). In Section 5, "Computerized Systems," the principles of system validation are detailed. Specifically, section 5.4.3 "Testing" outlines that test documentation must include test cases with expected outcomes. The execution of these tests involves comparing the actual outcome to the expected outcome to determine pass/fail status.

2. ISPE. (2008). GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems. The guide's sections on Verification (Testing), such as D4 "Test Execution," explicitly state that test records must document the evidence of testing, which includes the expected results from the test script and the actual results observed during execution, along with a pass/fail determination.

3. U.S. Food and Drug Administration (FDA). (2003). Guidance for Industry: Part 11, Electronic Records; Electronic Signatures — Scope and Application. While a broader guidance, it reinforces the need for validated systems. The principles of validation inherently require documented evidence that the system performs as intended, which is demonstrated through testing where actual results meet expected results. A failure is documented when they do not.

4. Coons, S. J., Eek, D., & Gater, A. (2014). From Paper to Electronic Patient-Reported Outcome (ePRO) Instruments: A Commentary on the ISPOR ePRO Good Research Practices Task Force Report. Value in Health, 17(5), 483–486. This article discusses the validation of ePRO instruments, which includes user acceptance testing (UAT). UAT, like all formal testing, relies on test scripts that define expected outcomes, and the documentation of these tests captures the actual outcomes. (See section on "Usability Testing"). DOI: https://doi.org/10.1016/j.jval.2014.05.005