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Chapter 4: Software for Medical Systems > 4. Risk Management - Pg. 193

Software for Medical Systems 193 document is checked into the VCS or released. Problems should not be deleted from the database once they are closed. As I have defined the process, should the issue arise again, you would have to create a new issue. You could use various policies. This ends the corrective action process. 3.17. Reports If you use a defect-tracking database, there are any number of reports to run and metrics to collect. ANSI 62304 requires you to analyze defects to detect trends and take corrective action in your development process [25], so metrics are not optional. Probably most important is the found/closed rate for defects. You want the trend for open defects to be downward over time, especially as you get close to release. Also, at some regular interval, the software team should meet to review all non-closed issues, to make sure that issues are not stuck in some intermediate state, such as in progress. 3.18. Software Observation Reporting and Version Control The SPR process and VCS are closely related. Especially for released software, no changes