The Functional Requirement document (also called Functional Specifications or Functional Requirement Specifications), defines the capabilities and functions that a System must be able to perform successfully.
Functional Requirements should include:
- Descriptions of data to be entered into the system
- Descriptions of operations performed by each screen
- Descriptions of work-flows performed by the system
- Descriptions of system reports or other outputs
- Who can enter the data into the system.
- How the system meets applicable regulatory requirements
The functional specification is designed to be read by a general audience. Readers should understand the system, but no particular technical knowledge should be required to understand the document.
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Examples of Functional Requirements
Functional requirements should includes functions performed by specific screens, outlines of work-flows performed by the system and other business or compliance requirements the system must meet.
Interface requirements
- Field accepts numeric data entry
- Field only accepts dates before the current date
- Screen can print on-screen data to the printer
Business Requirements
- Data must be entered before a request can approved
- Clicking the Approve Button moves the request to the Approval Workflow
- All personnel using the system will be trained according to internal SOP AA-101
Regulatory/Compliance Requirements
- The database will have a functional audit trail
- The system will limit access to authorized users
- The spreadsheet can secure data with electronic signatures
Security Requirements
- Members of the Data Entry group can enter requests but not approve or delete requests
- Members of the Managers group can enter or approve a request, but not delete requests
- Members of the Administrators group cannot enter or approve requests, but can delete requests
Depending on the system being described, different categories of requirements are appropriate. System Owners, Key End Users, Developers, Engineers and Quality Assurance should all participate in the requirement gathering process, as appropriate to the system.
Requirements outlined in the functional requirements are usually tested in the Operational Qualification.
Additional Comments
The functional specification describes what the system must do; how the system does it is described in the Design Specification.
If a User Requirement Specification was written, all requirements outlined in the user requirement specification should be addressed in the functional requirements.
The Functional Specification should be signed by the System Owner and Quality Assurance. If key end users, developers or engineers were involved with developing the requirements, it may be appropriate to have them sign and approve the document as well.
Depending on the size and complexity of the program, the functional requirements document can be combined with either the user requirements specification or the design specification.
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Frequently Asked Questions
Q: What is the difference between a User Requirement Specification and the Functional Requirement Specification?
A: User Requirements describe the End Users requirements for a system. Functional Requirements describe what the system must do.
Q: Can I see an example of a functional specification?
A: We have an sample functional specification for an Excel spreadsheet available for download.
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Acronyms
Functional Requirement Specification, Functional Specification, Program Specification, Functional Specs, Functional Spec, FRS, FS
Additional Resources
Validation Document Resources
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