Template: Software Architecture Checklist

Updated April 26, 2024

Template Download

This is a free template, provided by OpenRegulatory.

If you are a user of Formwork, our eQMS software, you can save a lot of time by choosing “QMS” on the top menu and “OpenRegulatory Templates” on the left menu, and then opening 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, don’t re-use this for commercial purposes).

Download as Word File

docx

Download as PDF

pdf

Copy-paste to Google Docs

html

Download as Markdown file

Talk To A Human?

We also offer consulting if you need a more hands-on approach. We’ve helped 150+ Healthcare companies. Take a look!

Template preview

Regulatory references:

IEC 62304, para. 5.3.6 [class B, C]

Relevant other documentation:

SOP Software Development
User needs / stakeholder requirements
Design input / software requirements
Software architecture description
(…)

1. Checklist

Criteria	Pass / Fail
The software architecture is in agreement with the software requirements.	( ) Yes ( ) Improve:
All software systems are listed and their respective safety class is stated.	( ) Yes ( ) Improve:
All software components are listed and described, including interfaces.	( ) Yes ( ) Improve:
All software units are listed and described.	( ) Yes ( ) Improve:
(Optional) Further architecture is described, e.g. databases, security and data protection requirements.	( ) Yes ( ) Improve:
The software architecture can be implemented with our given resources.	( ) Yes ( ) Improve:

2. Comments

3. Results

( ) Software Architecture passed
( ) Software Architecture not passed
( ) Software Architecture passed with the following obligations: <Insert if applicable>\

Template Copyright openregulatory.com. See template license.

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