Functional Requirment

The Functional Requirements Specification documents the operations and activities that a system must be able to perform.

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 Requirements 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.

Examples of Functional Requirements

Functional requirements should include 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 1 accepts numeric data entry.
• Field 2 only accepts dates before the current date.
• Screen 1 can print on-screen data to the printer.

Business Requirements

• Data must be entered before a request can be 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 can not approve or delete requests.
• Members of the Managers group can enter or approve a request but can 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 Specification are usually tested in the Operational Qualification.

Additional Comments

The Functional Requirements 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 Specification.

The Functional Requirements 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 Specification document can be combined with either the user requirements specification or the design specification.