A Functional Requirements Specification describes thefunctions and behaviors through which a system fulfills the user requirements.
Functional requirements should be traceable to relevant userrequirements and forward to applicable risks, design or configuration elements,and verification activities.
For configurable platforms, the FRS may be combined with orsupported by a configuration specification. Supplier documentation may describestandard product functions, while the regulated company’s documentationidentifies which functions are enabled, configured, integrated, customized, orrelied upon.
Functional requirements may be prepared by businessanalysts, system owners, implementation teams, suppliers, developers, orintegration partners. Responsibilities should be defined in the validation planor applicable procedure.
Frequently Asked Questions
Is an FRS always required?
Documented functional requirements are normally necessarywhen functions, configuration, or custom development must be specified andverified. They do not necessarily have to reside in a separately titled FRS.
Who writes the FRS?
The author depends on the delivery model. The FRS may bewritten by internal IT, business analysts, a product team, developers, animplementation partner, or the supplier, with appropriate business, technical,and quality review.
Can the URS and FRS be combined?
Yes. A combined specification can be appropriate where thesystem and process are sufficiently simple or where the methodology supports anintegrated requirements model. Clear identification and traceability should bepreserved.