Template: Bug Fixes Documentation List

Template Download

This is a free template, provided by OpenRegulatory.

If you are a user of Formwork, our eQMS software, choose “QMS” on the top menu and “OpenRegulatory Templates” on the left menu, and then open the relevant folder to find this template ready to load into Formwork.

If, for some mysterious reason, you’re using a different QMS Software, you can also simply download this template – specifically, as Word (.docx), PDF, Google Docs or Markdown file. Scroll down for a preview!

The template license applies (don’t remove the copyright at the bottom).

Tired of copy-pasting? If you want to save time and edit these templates directly, you can use Formwork, our eQMS software. And if you’re looking for step-by-step instructions for filling them out, check out our Wizard 🙂

Don't Miss Updates to This Template
Subscribe to our newsletter and we'll keep you posted on which templates we've changed.

Questions? Still Lost in Regulation?

Good news! Our goal is to provide lots of stuff for free, but we also offer consulting if you need a more hands-on approach. We get stuff done really fast. Have a look!

Template preview
RegulationsDocument Section
IEC 62304, Chapter 9All

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 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)
#T123#T132
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

Template Copyright openregulatory.com. See template license.

Please don’t remove this notice even if you’ve modified contents of this template.

Template preview

Comments

Leave the first comment