Design Specifications describes how a System performs the requirements outlined in the Functional Requirements. The design specification should include enough detail that a competent developer could create the system based on the specification. All requirements outlined in the functional specification should be addressed; linking requirements between the functional requirements and design specification is performed on the Traceability Matrix.
Design Specifications may include:
- Specific inputs, including data type, 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
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System Requirements and verification of the installation process are usually tested in the Installation Qualification. Input, Processing, Output and Security testing is usually tested in the Operational Qualification.
Due to the extremely technical nature of most design documents, there is currently some discussion in the industry about who needs to review the design specification. The design specification is reviewed and approved by the System Owner, System Developer and Quality Assurance. Quality signs to ensure that the document complies with appropriate regulations and that all requirements were successfully addressed, but do not necessarily need to review technical information.
Depending on the size and complexity of the program, the design specification may be combined with the function requirements document.
Frequently Asked Questions
Q: Can I see an example of a design specification?
A: We have an sample design specification for an Excel spreadsheet available for download.
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Acronyms
Software Design Specification, Design Specification, Design Specs, Design Spec, SDS, DS
Additional Resources
Validation Document Resources
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