Hardware Design Specification.
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The Hardware Design Specification is a description of the hardware on which the software resides and how it is to be connected to any existing system or plant equipment. This document defines the requirements for related hardware and methods of control.The Hardware Design Specification may include:
A full description of all equipment utilizing and impacted by the software, including all hardware / equipment interfacing with the software. Comprehensive specifications for all such equipment and instrumentation. Details on all modes of process inputs and outputs.
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The hardware requirements specification (HRS) will follow a format such as:
Purpose: Clearly define the objective of the hardware requirements specification. Detail where it “fits” into the overall software development documentation.
Scope: What is the extent of influence and impact of the software under development and revision.
Definitions and acronyms: List out, as the reviewer may not be fully familiar.
Reference and supporting documents: Include here for clarity, ensure relevant identification numbers are included.
Description and background: Provide a general outline of the software under development, the intended objectives, the customer expectations, etc.. The purpose is to provide a short introduction to the broader project.
Specific hardware requirements:
Information on the hardware which permits development and testing to be performed to the expectations of the customer.
This may include the full hardware functional requirements, reliability expectations, usability requirements, performance requirements, maintainability, design constraints, interface expectations (hardware, software, communication, …), details on user expected input devices, input and output displays, …
Performance expectations to environmental, shock, wear and tear limits may also be included.
Regulatory and compliance requirements:
Details of regulations, licenses, corporate and industry standards which need to be met.
Software Validation.
- Agile Development. Extreme Programming. Spiral Validation. Etc..
- Information | Understanding | Best Practice >>>
General Principles of Software Validation FDA
EU Commission guidance on stand alone software
ISO/IEC 12207 Systems & Software Engineering – Software Life Cycle Processes