OpenRegulatory Template

Bug Fixes Documentation List

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.

Documentation of Bug Fixes

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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