NEU!! Entwickelt SxMDs mit einem strukturierten eQMS, einschließlich auditfähriger SxMD-Vorlagen, die an EU- und US-Standards angepasst sind. Mehr Erfahren!
Agile Compliance - Software development planning
In order to ensure an organized and efficient software development process, it is imperative to maintain an up-to-date and well-documented software development plan, as stated in sections 5.1.1 and 5.1.2.
It cannot be a collection of (uncontrolled) confluence pages or word documents. It needs to be a controlled document, meaning it needs to be written, reviewed, approved and released and version controlled. It needs to be clear when each version of the plan was used, and which documentation was written according to which version of the plan.
What has to be covered by the software development plan?
The plan needs to take the software safety classification into account, and therefore will be more extensive for Class C compared to class A software.
