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traceability,traceability system design PDF

发布时间:2024-06-19 18:20:22 投资攻略

Traceability System Design PDF

1. Bidirectional Traceability

1.1 Establish bidirectional traceability between system requirements and elements of the system architectural design.

NOTE 4: Bidirectional traceability covers allocation of system requirements to software requirements, to software design, and to source code, and ensures that final software matches initial system requirements.

2. System Design Review (SDR)

2.1 SDR concepts, theory, and design principles from the perspective of signal processing in a Software Defined Radio (SDR) system.

After an introductory overview, SDR design includes specified requirements, design description, and the system itself to ensure the system is built correctly.

3. MHRA GMP Data Integrity Guidance

3.1 MHRA GMP Data Integrity Definitions and Guidance for Industry

Data integrity is fundamental in a pharmaceutical quality system to ensure compliance with regulations and maintain the integrity of data throughout the product lifecycle.

4. Software Traceability Roadmap

4.1 Software Traceability: A Roadmap

This roadmap outlines how traceability can support data resolution and verification processes, ensuring that software meets specified requirements and design descriptions.