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update: LLM Prompt ergänzt.

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requirements-engineering-process.md
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@ -140,6 +140,24 @@ Traceability is crucial for tracking requirements through all stages of developm
## LLM Prompt example
```text
Our situation is as follows:
- We are a med tech company producing physical devices incl. embedded hardware and software, mobile apps connected via bluetooth and cloud components like user management device management for those mobile apps
- We are the IT department offering IT infrastructure in the Azure cloud for those products. We are not creating the products and we are not responsible for the processes involved to create the products. We are only providing infrastructure for those products and are responsible for IT infrastructure changes.
We have identified the following list of regulations as potentially relevant:
- ISO/IEC 62304 Medical device software - Software life cycle processes
- ISO/IEC 27001 Information technology - Security techniques - Information security management systems - Requirements
- ISO/IEC 27017 Information technology - Security techniques - Code of practice for information security controls based on ISO/IEC 27002 for cloud services
- ISO/IEC 27002 Information security, cybersecurity and privacy protection Information security controls
- ISO/IEC 27018 Information technology - Security techniques - Code of practice for protection of personally identifiable information (PII) in public clouds acting as PII processors
- ISO 14971 Medical devices Application of risk management to medical devices
- ISO 13485 Medical devices Quality management systems - Requirements for regulatory purposes
- FDA 21 CFR Part 820: Title 21 Code of Federal Regulations Part 820 - Quality System Regulation
- FDA 21 CFR Part 11: Title 21 Code of Federal Regulations (CFR) Part 11 - Electronic Records; Electronic Signatures
- ALCOA+ Principles Compliance
You are an expert in the field of requirements engineering in the regulated environment of a med tech company. I need your support in writing requirement.
When writing requirements, use the following format to clearly articulate the need, the stakeholder’s perspective, the desired outcomes, and the rationale. Adhere strictly to this structure:
When [condition or situation triggering the requirement],
@ -154,6 +172,7 @@ Key Guidelines:
4. Rationale: Use "This ensures..." to explain why the requirement is important or what benefit it provides.
5. Add a list of relevant acceptance criteria
6. Add a list of test cases
7. Add a list of regulations that are relevant to the requirement inlcluding the requirement of the regulation and the implication of the requirement.
Example:
Title: Document Authorship and Timestamps
@ -169,6 +188,10 @@ Acceptance criteria:
Test cases:
- Verify author name is captured on document creation.
- Verify timestamps are added for all document modifications.
List of regulations:
- ALCOA+ Principles Compliance
- Requirement: Attributable
- Implication: Every document must record the author and timestamps for creation and modifications.
The input data is: