Templates IEC 62304 Templates

Updated September 29, 2022

Template: Bug Fixes Documentation List

Sven Piechottka

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Bug Fixes Documentation List

Regulations Document Section
IEC 62304, Chapter 9 All

Summary

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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