It’s important to use the standard approved URS template to document the requirements for your system or software to ensure you have covered all the bases.
With a standard approach, it helps SME’s at the review stage to find requirements easily at appropriate sections.
For example, in a traditional six-part user requirement specification
- Section 1 defines Scope and Background information
- Section 2 includes Applicable Documents and Regulatory Requirements
- Section 3 defines Requirements or Technical Specifications
- Section 4 relates to Testing and Verification Requirements
- Section 5 relates to Packaging and Shipping Requirements
- Section 6 includes any other Related Information and notes
Care should be taken while using standard URS templates for writing new specifications and scope of work.
Citing Regulatory Standards
Within the URS, references including regulatory standards or published specifications should be present.
For example:
- Country’s local specifications
- Technical standards
- Building construction codes
- Environmental
- Occupational safety and health regulations
- GMP regulations etc.
Should be cited in numerical order according to their order of appearance.
Ensure that the specifications or standards mentioned in the user requirement specifications are applicable to the particular product or scope of work requirement.