Software Architecture Checklist
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
<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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Template Copyright openregulatory.com. See template license.
Please don’t remove this notice even if you’ve modified contents of this template.