User Requirements Template for a Supervisory Control and Data Acquisition (scada) Process Control System notes for use of the User Requirements Template

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I.0Introduction

I.1.Purpose

This User Requirements Specification (URS) defines the purpose of the
. It identifies the functions to be carried out, the data on which the system will operate, and the operating environment. It also defines any non-functional requirements, constraints such as time and costs, and what deliverables are to be supplied.

I.2.Origin and Context

has been contracted by to develop the URS for the
, to be located in
. The format and content of this URS are based on the Good Automated Manufacturing Practices (GAMP) Guide available through the International Society for Pharmaceutical Engineering (ISPE).

The project role and significance of this document is identified in:

Once approved, this document will provide a foundation for the development of functional specifications, design specifications, and Performance Qualification testing protocols. Modifications to, and/or deviations from, the specifications in an approved URS are subject to formal change control procedures.

The following documents are related to the

URS:

#	Reference	Contains
1		Project Scope and Charter
2		Process design
3		Applicable automation standards
	…	…

I.3.Scope

This document begins to define the process control system requirements for:

Hardware and software platforms
Network communication
Equipment control
Automated process area sequencing
Process equipment modeling for Batch management
Human Machine Interface (HMI)
Electronic data and record storage

This document does not cover:

Non-GMP Building Management System (BMS)
GMP BMS
Programmable Logic Controllers Hardware and Software
Raw Material Information System
Industrial Technologies (IT) systems hardware and software

The key objective is to provide a process control system with the required functionality and flexibility while simultaneously meeting the requirements of ISPE GAMP 4, cGMP, FDA’s 21 CFR Part 11, ISA S88.01, and policies and procedures. The benefit of meeting or exceeding these key objectives is a profitable manufacturing facility offering flexibility to meet market demand.

I.4.Document Organization

In accordance with the GAMP Guide description of URS contents, the remainder of this document includes the following sections:

#	Section	Sub-Section	Contains
2	Overview	Background	Facility Overview, Project Overview, and Automation Overview
		Key objectives and benefits	General statement of automation constraints.
		Main functions and interfaces	Description of the process control system role.
		Applicable GxP Requirements	Specific identification of constraining regulatory requirements
		Other Applicable Regulations	Specific identification of other constraining regulatory requirements
3	Operational Requirements	Functions	Functions required, calculations, modes of operation, performance and timing requirements, action required in case of failure, safety, security
		Data	Definition of data, capacity requirements, access speed requirements, archive requirements, data security and integrity
		Interfaces: User Interfaces	User roles/functions and the interface provisions
		Interfaces: System Interfaces	Interface with other automated or computerized systems
		Interfaces: Equipment Interfaces	Interface to sensors and actuators
		Environment: Layout	Space(s) provided for automation equipment
		Environment: Physical Conditions	Physical conditions prevalent in space(s) provided for automation equipment
4	Constraints	Project Constraints	Timescales and milestones, procedural constraints
		Compatibility	Existing systems, automation strategies, and automation policies
		Maintenance	Availability, ease of maintenance, expansion capability, likely enhancements, expected lifetime, and long term support
5	Life Cycle	Development	Methodologies, project management, and quality assurance
		Testing	Testing strategies, special requirements, and simulations
		Delivery	Information related to required supplier deliverables
		Support	Support required after system acceptance
6	Glossary	Terminology	List of document terms and their meanings
6	Glossary	Acronyms	List of abbreviations and their meanings

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