Template: Software Architecture Checklist

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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

CriteriaPass / 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

<Insert comments if applicable>

3. Results

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


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