In Earlier post we understand Function Requirement Specification (FRS) & Its Checklist that should followed while finalizing FRS.
Now in this article we are going to understand What is Design Specification, Its Type & Elements in Computer System Validation.
The Design Specification (DS) describes the hardware and software platforms of your system to be validated. The DS also quantifies the how each system component is to be configured as well as how each component factors into making a completed system.
Design Specification: The system design specifications is a description of what software should do and how it should it. For each requirement, a set of one or more design elements may be produced.
Vendor or Implementation partner shall develop and provide the DS to Project team for review & Approval
Some general guidelines should be kept in mind while preparing the DS –
- The Design Specification must state the system design from a technical and infrastructure perspective
- Each Design specification statement must be stated with technical clarity.
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Design Specification should ensure the following:
- Design satisfies product and process requirements
- Design appropriately addresses critical aspects of manufacturing systems
- Risks to product quality and patient safety have been identified
- Unacceptable risks are mitigated by design or other means
Types of Design Specification
- Hardware Design Specification (HDS)
- Software Design Specification (SDS)
1 HDS
The HDS Hardware Design Specification is a document that provides an overall description of the hardware and implementation. It provides description of main components and interactions and as well requirement for proper connection to utilities and installation.
2 SDS
The SDS Software Design Specification is a document that provides an overall description of the software, implementation,functions and interface with the users.
Design Specifications may include:
- Specific inputs, including data types, to be entered into the system
- Calculations/code used to accomplish defined requirements
- Outputs generated from the system
- Explaining technical measures to ensure system security
- Identify how the system meets applicable regulatory requirements
Design Specification document contains all of the technical elements of the systems includes:
- Database Design – file structures, field definitions, data flow diagrams, entity relationship diagrams
- System Use- Description of the intended use of the system
- Logic/Process Design – pseudo code for logic and calculations
- Security Design – virus protection, hacker protection
- Interface Design – what data will move from one system to another; how and how often, and failure handling
- Architecture Design – required hardware, operating systems, application versions, middle ware, etc.
- Network Requirements
- Specific peripheral devices – scanners, printers, etc.
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