URS - USER REQUIREMENT SPECIFICATIONS

What is URS?
The URS means User Requirement Specification is a first document to define the procedure for the procurement of any equipment.
The user requirement specification document should be very clear why we need this equipment and for which area and application.
User Requirement Specifications also known as URS is a document, which describe the basic requirement of any Equipment, Instrument, System or
Facility in terms of Make, Model, capacity, Process, Control System and other cGMP requirements.
BASIC FLOW FOR PREPARATION OF THE URS IS AS BELOW:
➢ Generally URS is prepared by the Person from the user department.
➢ After preparation of the URS it will be reviewed by user department, engineering department, Quality Assurance. If required it can be reviewed by
other cross functional department also.
➢ After review by cross functional department, it will be sent to QA Head for approval.
➢ Once the URS is approved it will be sent to Vendor for approval. Once approved by vendor Purchase order shall be raised.
➢ In some cases where equipment is commercially available, URS may not required to be prepared. For such equipment technical & functional
specification from vendor can be considered as URS. For example in-process testing instruments like Hardness Tester, etc.
A properly written URS helps the supplier or vendor to fully understand the client’s requirements. This, in turn, helps the supplier design a system or
specialized equipment that completely satisfies needs and expectations. Alternatively, if there is no URS, it can create confusion between both parties
blaming each other for failures resulting in the waste of time and resources.
A URS also helps with the completion of regulatory requirements. Some regulatory bodies require that the URS is completed before the purchase of
any equipment. It also forms a basis for validation activities including installation qualification (IQ) and operational qualification (OQ).
During User Requirement speciation preparation keep the documents as per all the regulations like environmental safety, machine safety
controls, and health shall be considered.
The following guidelines should be followed during the preparation of the URS:
➢ Each requirement statement to be uniquely referenced and no longer those 250 words
➢ Requirement statements should not be duplicated or contradicted.
Arvind Kumar Srivastava , Mobile No. 9817039581 , Email ID : [email protected]
➢ The URS should express requirements and not design solutions.
➢ Each requirement should be testable.
➢ The URS must be understood by both user and .supplier; ambiguity and jargon / terminology should be avoided.
➢ The use of diagram is often useful.
➢ The scope for readers to make assumptions of misinterpret should be minimized.
➢ Wherever possible, the URS should distinguish between mandatory / regulatory requirement and desirable features.
Points should be considered in the user requirement specification format or Key Sections of a URS:

USER REQUIREMENT SPECIFICATION

Sr. No. Headings Description

To establish specification for Equipment / system to be install at Site / Name of Company as per
1. Objective
requirement of their intended use and cGMP compliances

2. Scope This URS is applicable to the Equipment / System that will be installed at Site / Name of Company

The manufacturer/supplier shall be responsible for the supply of the following system outlined in
this specification including design, engineering, fabrication, materials of construction (MOC),
inspection, testing and certification of material, specified documentation, packaging, delivery,
installation, commissioning validations, calibrations, performance guarantee of the materials and
equipment supplied.

3. System Description

Description A short Description of Equipment which are required with its Principle

4. General Requirements

Name of Equipment Mention the Name of Equipment to be required

Arvind Kumar Srivastava , Mobile No. 9817039581 , Email ID : [email protected]

 Client Name of Client / Company

Area of Installation Name of Area the Equipment to be Installed

Dimension and Environmental Dimension & environmental condition in which equipment can be run based on the room where
Condition equipment will be installed.

Capacity The Capacity of Equipment to be required for the intended purpose

Material of Construction and

Mentioned the MOC with its Smoothness Finishing (Ra) to be required.
Finishing

Design of Equipment Required of mention the Design of Equipment like GMP Model or any other

Usage of Equipment Mention the minimum working hour of equipment.

A brief detail of the process of the equipment with connectivity of other area and equipment if
Process Requirements
required

Technical Requirements If any specific technical requirement regarding the process of the equipment

Utility Requirement A brief details of utility requirement for the Equipment / System

5. Components Details

Name of Major Component/s Details of Major Components with Preferred Make, Model, Capacity, Range, etc.

Name of Minor Component/s Details of Minor Components with Preferred Make, Model, Capacity, Range, etc.

Material of Construction
6. Give the details about the material of construction like stainless steel and its grades and
MOC
Certificates of same shall be required.

Arvind Kumar Srivastava , Mobile No. 9817039581 , Email ID : [email protected]

7. Control Systems

MMI Preferred Make, Type, Model, etc.

Data Security Audit trail

PLC Mentioned the Details of Make, Model, Type

User Interface Mention if required to be compatible with SCADA or DCS

Interface to other Mention if required interface with other Equipment / System / Instrument

Data storage Capacity Minimum Storage Capacity

Password Protection Mention the Required Password Protection up to 3 Level

Software Specifications Preferred Make, Type, Version, etc.

Hardware Specifications Preferred Make, Type, Model, etc.

Others Specify if any other object is required

8. Alarms, Interlock & Safety Features

Alarms Mention the all required alarms in equipment

Interlock Mention all required interlocks in equipment

Mention Safety features like emergency switch

Earthing, Power Failure
Safety Features
Noise Level
Flame Proof / Non Flame Proof

Arvind Kumar Srivastava , Mobile No. 9817039581 , Email ID : [email protected]

 IP Rating etc.

Other If Any other Safety Precaution is Required Please Specify

9. Documentation

Functional Specification Should be Required

Test Specification Should be Required

Mentioned the Requirements of Certificates Like Material of Construction, Components Test

Certificates
Certificates, Calibration Certificates, Performance Test Certificate etc.

Manual Mention the requirement of the Operation & Maintenance Manual

Drawings Mentioned deferent type of drawing required like GA, P&ID, Electrical, etc.

Recommended SOP Standard Operating Procedure For Cleaning, Maintenance and Operation Required

FAT / SAT Mention if Factory Acceptance Test or Site Acceptance Test is required

Qualification Documents It include the FAT , Design, SAT , Installation, Operational & Performance Qualification

The Calibration Certificates for all instrumentation and Test Certificates for Major Components
Calibration Certificates
like Motors , Pumps , Gear Box etc.
All documentation are required for Software and Verification Test , PLC Validation and its
Software
documentation
Vendor shall provide full and complete Guarantee for one year's trouble free performance from
Guarantee Certificates
date of successful commissioning / final acceptance.

Others Please specify if any other document is required

Arvind Kumar Srivastava , Mobile No. 9817039581 , Email ID : [email protected]

 ➢ The Vendor must comply with good documentation practice and deliver the necessary
documentation to prove that the Purified Water System with its equipment is constructed
according to GMP guidelines and in line with our URS. Thus, it must be documented that the
materials used are compliant with GMP guidelines and the appropriate validation tests have
been performed.
➢ Commissioning is performed by the Vendor and is defined as the process by which the systems
and equipment are tested to ensure / verify that the design of the system is fit for its intended
use, according to Good Engineering Practice (GEP). The commissioning process starts at the
pre-design phase and continues through construction until the final qualification is performed;
it can be divided into phases of pre-design, design, construction and operation.
➢ The (equipment / System) , with all options, equipment, and the documentation shall be
delivered to the User’s receiving address Which are mentioned in PO.
10. Scope OF Vendor
The vendor shall provide a full description of the equipment and the vendor shall specify the
dimensions of all items. The Supplier / Vendor shall provide a training course to Operational &
maintenance people on troubleshooting and repair of the system . The Supplier shall identify
components items are mounted on the skid that are kept in inventory at the supplier.
➢ Installation, operation, and maintenance instruction documentation for the system shall be
developed to a level that is comprehensible to a high school +Industrial technician course.
➢ The Supplier shall provide the documentation for preliminary review. The Supplier shall
provide documentation reflecting “as-built” condition with final delivery.
➢ All final documents shall be shipped with transmit that identify them as contractually required
documents. All final documents and drawings shall reflect “as-built” condition.
➢ All documents shall in the English language and supplied with hard copies and electronic
versions supplied in the format identified for each document:
Arvind Kumar Srivastava , Mobile No. 9817039581 , Email ID : [email protected]
 ➢ Training- vendor to include scope of training for user deputed personnel at site and at vendors’
formal training center/school.
➢ Post Start-up Support –Vendor to depute software-programming engineer for any minor
changes if required after running the system for three to six months.
➢ The User Requirement Specification has been discussed and agreed upon. We hereby declare
that we will supply the equipment / system as per above laid down specification.

11. URS Approval

Prepared By ----- User Name, Sign & Date of Person who has prepared URS

Reviewed By ------ User Name, Sign & Date of Person who has prepared URS

Reviewed By ------ Engineering Name, Sign & Date of Person who has prepared URS

Reviewed By ------ Health and Safety Name, Sign & Date of Person who has prepared URS

Approved By ---- Head QA Name, Sign & Date of Person who has prepared URS

The User Requirement Specification has been discussed and agreed upon. We hereby declare that
12. URS Acceptance By Vendor We will supply the equipment / system as per above laid down specification.
Name, Sign & Date of Vendor who has Accepted the URS

Arvind Kumar Srivastava , Mobile No. 9817039581 , Email ID : [email protected]