User requirement specification 

(URS) is a list of all the requirements

from the user, like equipment to be purchased. After the preparation
of the list, the documents are sent to the manufacturer to get the
required materials as per the given criteria.
The user department will raise the indent for his requirement regarding
machine equipment or software. He/She will give all the
requirements in the format of URS, which include the functional and
technical specifications for the machine equipment or software. This
specification in the written format is defined as URS. It shall be very
specific.
here should not be any confusion during the preparation for approval.
Functional as well as technical aspects shall be clearly mentioned.
The number of spare change parts required shall be mentioned in
URS.
Users should also give the details of other areas which are going to
affect if the machine is procured or which are the other areas that
need to modify such as the environmental (AHU) control system.
Also, keep in mind whether this modification is possible and feasible;
is it going to impact the other existing system. URS is a supporting
document for the preparation of design qualifications.

 Name of the user department

 Location
 machine/equipment/software name
 Purpose of the machine/equipment/software
 Other areas of impact (AHU, movement, and space)
 Parameters to be considered for the URS.
 Model making Name with specification, and quantity with the
remark.
 Capacity: give the detailed specification and quantity likes
requirement in Kilogram or liters.
 The material of construction: give details about the material of
construction like Stainless steel and its grades.
 Give details about Instruments on machine likes Metal detector,
Camera inspection system, and pinhole detector, etc.
 Required calibration details with the specification with remarks
  Details specification: baffles, Dia, punches, Guide track, cutter, and
channel.
 Specified details about required tools
 Documentation like FAT / SAT/ Qualification/ manuals
 Environmental: (Include the temperature and humidity of the area ) /
health safety requirements (like MCB and safety Guard) and Control
(Specify needs of equipment, interfaces, output forms (e.g., USB)
 Critical control points
 Others:
 Utilities. Utilities. Define the kind of power supply to use for the
equipment, the requirement of UPS, or other utility requirements.
Include water system, quality, or compressed gas, if required.
 Availability. Limitation of operation time for the equipment
 Supporting Documents. Operating manuals, warranty, parts, spare
parts, circuit diagrams.
 User requirement specification document Shall be signed by an
authorized person in the column prepared by, reviewed by, and
approved by. In the end, review, revise, and approve the URS. The
next step is the design qualification.
1. Are User Requirements Specifications always required for
validation?
When a system is being created, User Requirements Specifications
are a valuable tool for ensuring the system will do what users need it
to try to do. In Retrospective Validation, where an existing system is
being validated, user requirements are equal to Functional
requirements.

Standard Operating Procedure

Title: Equipment Specification and Qualification

_____________________________________________________________________________________
_

Copyright©[Link]. All rights reserved

Unauthorized copying, publishing, transmission and distribution of any part of the content by electronic
means are strictly prohibited. Page 3 of 7

engineering documents may support these requirements without the need to repeat any

work or compromise validation standards.

To support this goal, the Project Manager will need to ensure that:

 All of the documents that are required at the end of the project are prepared, approved

and collected throughout the project.

 Document versions and approvals are managed in line with project milestones.

 The relevant departments for review and approval of documentation are identified and

included in the project.

2. Procurement Documents

2.1. The documents used for the procurement of equipment should consist:

 User Requirement Specification

 Relevant Standard Demand Specifications, and

 Purchase Agreement.

These documents should form part of the Purchase Order.

2.1.1. The User Requirement Specification covers the specific requirements of the

equipment to be procured. It is to be prepared by the procurer.

2.1.2. The Standard Demand Specifications cover the general standards for equipment for

manufacturing premises. They are the reference points regarding the principles,

requirements and precautions that should be followed to safeguard product quality,

EHS objectives, GMP and GEP on site. They are also intended for application to

achieve efficient standardisation of equipment, components, hardware and software

in the facility.

2.1.3. These Standard Demand Specifications should be reviewed before undertaking any

procurement. If they contain any clauses that are pertinent to the equipment

procured, they should be included in the demands of the procured item.

2.1.4. For the case of non-conformance with any clause in the Standard Demand

Specifications, agreement to the alternatives shall be reached with the Demand

Specification Owner before proceeding with the Purchase Order.

2.1.5. The requirements specified in the Demand Specifications should form part of the

inspection checklist for the equipment for Factory Acceptance Testing and Site

Acceptance Testing. The completed checklists should be attached to the Installation

Qualification documentation.

2.2. User Requirement Specification

2.2.1. The URS specifies the scope of work and the process requirements for the

equipment or system, (i.e. what the equipment or system is supposed to do).

2.2.2. The URS should be checked to ensure it is clear, complete, realistic, definitive and

testable. The URS should also be approved by the Engineering Service and, if it

has Direct or Indirect GMP impact, a representative from the Quality Assurance

department.

2.2.3. Once approved, this document forms part of the Validation documents and is to be

archived as per GMP document.

2.2.4. The URS should:

Standard Operating Procedure

Title: Equipment Specification and Qualification

_____________________________________________________________________________________
_

Copyright©[Link]. All rights reserved

Unauthorized copying, publishing, transmission and distribution of any part of the content by electronic

means are strictly prohibited. Page 6 of 7

Project Manager, to demonstrate control of the development ‘life-cycle’. Electronic copies of

final versions should be filed.

3.5. Test documents, generated by the supplier or buyer’s project teams, may be used to

complement Validation documents and may limit the need for additional Validation testing.

Such an approach requires the prior agreement of the Validation Manager and will mean that

these test documents must meet the standards for Validation evidence.

4. Design Qualification Documentation

4.1. Design Qualification (DQ) is a process for assuring that the designs of equipment and
systems comply with the requirements for use and, most specifically, the code of GMP. The

process should commence prior to the construction or manufacture of the item in order to

minimise the impact of any omissions, errors or changes. A number of activities may be

conducted as part of the Design Qualification, including, but not limited to:

 Verification that design meets relevant URS or standards

 Verification that cGMP requirements are identified and met

 Examination of the material and personnel flow diagram

 Supplier Assessment / Audit

 Design Review (eg against a checklist, or by a team)

 Risk Assessments (eg Product Quality).

4.2. The Project Manager will initially determine the most appropriate review method, based on

the system impact, complexity and novelty. The proposed Design Qualification approach

should be documented and approved. A Design Qualification Report should record the

completion of all the planned activities and the location of any supporting evidence.

5. Installation Qualification Documentation

5.1. To complete Installation Qualification, the Project Manager should ensure that all the

relevant Installation Qualification documents have been completed.

The documents should include:

 All Mechanical Demand Specifications.

 Electrical Demand Specification.

 Instrumentation Demand Specification.

 SCADA Demand Specification.

 Control System Demand Specification.

 Technical Documentation Specification.

 EHS requirements in the EHS Verification Report.

 EHS Audit Report.

 Standard Installation Qualification documents relevant to the project should also be

completed.

 FAT report, covering the criteria and test results defined in the URS.
 SAT report, covering the criteria and test results defined in the URS.

6. Project Manager’s Responsibilities:

Design Qualification:

DQ may verifiyt that design of Equipment, System/facility is according to requirement of user and
current good manufacturing practices.

DQ defines the functional and operational specifications of the instrument and details for the conscious
decisions in the selection of the supplier.

The steps that should be considered for inclusion in a design qualification of the autoclave:

1. Description of the analysis problem

2. Description of the intended use of the equipment
3. Description of the intended environment