| Applicable Regulations | Document Section |
|---|---|
| IEC 62304, Chapter 9 | All |
Overview
This record serves to document the assessment and execution of all bug fixes following the company’s change management procedure.
Bug Fix Documentation
| Evaluation Criteria | |||
|---|---|---|---|
| Bug ID | #B01 | #B02 | (…) |
| Description of the Bug | Info box should appear when hovering over a button, but it doesn’t | Users find the text field difficult to use | |
| Date and Time of Occurrence | 01-04-2021 | 16-03-2021 | |
| Corrective Action | Implemented info box display on hover | Renamed the text field | |
| Preventive Measures | Created test scenario #T123 (link to file) | Introduced usability test scenario #U123 (link to file) | |
| Relevant Software Requirement | #REQ192 “Show user information on hover” | #REQ193 “Provide field for documenting information” | |
| Related Implementation Ticket (optional, e.g., Github Pull Request) |
(…) | (…) | |
| Related Test Documentation (e.g., System Test ID #121) |
#T123 | #T132 | |
| Test Completion Details (Date / Assessor) | 2021-04-15 by John Doe | 2021-04-15 by John Doe | |
| Relevant Risk Documentation | – | Risk ID #369 “User does not understand XYZ” | |
| Initial Incident Assessment by MDSO | No incident detected | No incident detected | |
| Initial Significance Assessment by QMO | Not significant | Not significant | |
| Updated Software Release Date | 2021-04-16 | 2021-04-16 |