Template: Bug Fixes Documentation List

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RegulationsDocument Section
IEC 62304, Chapter 9All


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 DescriptionHovering over button should display info box but doesn’tUsers do not understand how to use text field
Occurrence Date and Time01-04-202116-03-2021
Corrective ActionDisplay of information when hoveringRenaming text field
Preventive ActionAdded 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)
Test Completed (When / By Whom)2021-04-15 by John Doe2021-04-15 by John Doe
Affected Risk DocumentationRisk ID #369 “User does not understand XYZ”
Preliminary Incident Assessment by MDSONo incidentNo incident
Preliminary Significance Assessment by QMONot significantNot significant
Release Date of Updated Software Version2021-04-162021-04-16

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