| Prevention | Early Detection | Description |
|---|---|---|
| Walk through the software modification against application requirements and original design to assure completeness and correctness. | Code Review. Regression test. | The version 2.30 contains a A software bug resulting in a computation error, possibly not in the earlier version. NOT VALIDATED EITHER VERSION |
| Walk through the software modification against application requirements and original design to assure completeness and correctness. | Code Review. Regression test. | Incorrect analytical results for 3 variables. An error existed in the revised software. |
| Validate changes | Code Review. Regression testing. | Scan data may be lost during the process of archiving the data subsequently producing no images. Software contained errors in coding the scan data; A non-validated change caused the problem. |
| Walk through the software modification against application requirements and original design to assure completeness and correctness. Software control. |
Code review. Regression test. | Report of overinfusion. Misreading of loaded syringe size, activation of continuous rate mode, and syringe syphoning were all caused by software revisions that had not been properly validated. |
| Carry out software engineering practice from design, implementation to rollout, including requirement review, design review, code review, different phases of testing and configuration management to assure the product quality | Proper test plan and procedure. Proper release procedure. | Software yielded erroneous laboratory results. The manufacturer failed to validate the software and to audit its supplier to assure that the software was validated. |
| Carry out software engineering practice from design, implementation to rollout, including requirement review, design review, code review, different phases of testing and configuration management to assure the product quality | Proper test plan and procedure. Proper release procedure. | Systems software was not validated before release. |
| Carry out software engineering practice from design, implementation to rollout, including requirement review, design review, code review, different phases of testing and configuration management to assure the product quality | Proper test plan and procedure. Proper release procedure. | Software that controls gantry movement not fully validated. |
| Carry out software engineering practice from design, implementation to rollout, including requirement review, design review, code review, different phases of testing and configuration management to assure the product quality | Proper test plan and procedure. Proper release procedure. | Software version with errors had not been validated. |
| Quality assurance | Code Review. Inspection. Thorough unit test and system test. Proper test procedure. Proper release procedure. | In certain situation, incorrect action could be taken. The software had not been validated. |
| Proper test procedure. Proper release procedure. Configuration management. | Thorough unit test, system test and regression test. | Software was not validated; if invalid, could cause serious problem |
| quality practices; training; validation of changes | inspection, unit test | Failure to execute specific plan of events. No validation of software deisgn changes. |