| Regulations | Document Section |
|---|---|
| IEC 62304, Chapter 9 | All |
This list is used to document the evaluation and implementation of all bug fixes according to the company’s change management process.
| Evaluation Categories | |||
|---|---|---|---|
| Bug ID | #B01 | #B02 | (…) |
| Bug Description | Hovering over button should display info box but doesn’t | Users do not understand how to use text field | |
| Occurrence Date and Time | 01-04-2021 | 16-03-2021 | |
| Corrective Action | Display of information when hovering | Renaming text field | |
| Preventive Action | Added test scenario #T123 (link file) | Added usability test scenario #U123 (link file) | |
| Affected Software Requirement | #REQ192 “Display user information (…)” | #REQ193 “Provide field to document information (…” | |
| Corresponding Implementation Ticket (optional, e.g. Github Pull Request) |
(…) | (…) | |
| Corresponding Test Documentation (e.g. System Test ID #121) |
#T123 | #T132 | |
| Test Completed (When / By Whom) | 2021-04-15 by John Doe | 2021-04-15 by John Doe | |
| Affected Risk Documentation | - | Risk ID #369 “User does not understand XYZ” | |
| Preliminary Incident Assessment by MDSO | No incident | No incident | |
| Preliminary Significance Assessment by QMO | Not significant | Not significant | |
| Release Date of Updated Software Version | 2021-04-16 | 2021-04-16 |
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