SMB Validation

What does an FRS contain?

The Functional Requirements Specifications include (but are not limited to) the following common sections:

Identification of Writer, Approvers:
Provides documented evidence on the personnel involved in preparing and approving the document.

Revision History:
A revision history is maintained to record any changes to the document and the date they occurred.

Introduction:
Defines the purpose and scope of the Functional Requirement Specification with respect to the design of the utility or piece of equipment.

Overview:
Gives a background and objective of the utility or piece of equipment that is being considered with an overview of its functions.

Operational Requirements:
Will list the requirements for the function of the system which include, but are not necessarily limited to, Sequence of Operation, Cycle of Operation, and Machine Performance.

Control System Requirements:
Will list the requirements for the control system which include, but are not necessarily limited to, Functions, Safety, User Interfaces, Electronic Records and Signatures, Security, Alarms, and Utilities.

Hardware and Software Requirements:
Will list the specific requirements for the control system which include, but are not necessarily limited to, Interferences, Environment, Hardware, Operating System, and Application Software.

Glossary:
Definition of all the terms that have been referenced in the document.