SOP Preparation of User Requirement Specification (URS)
Objective: To lay down a procedure for preparation, review and approval of user requirement specification.
Scope: This procedure outlines the requirements, which shall be followed when creating a User Requirement Specification (URS), which is referred to as system or equipment design documentation.
This procedure applies to all systems or equipment utilized for GMP applications, including Product Processing, Laboratory, Environmental Monitoring and Engineering /Maintenance systems that are directly related to manufacture, control and evaluation of pharmaceutical product intended for commercial or clinical distribution.
Requirements of this procedure do not apply to legacy systems and equipment purchased or installed prior to the procedure effective date.
Responsibility:
User Department: Create and review of URS.
Describe current and proposed business requirements pertinent to the system for which the design documentation is written.
Engineering: Assure systems and equipment for GMP applications are installed according to design specifications (may be delegated to others).
Assist as necessary in creating URS to meet the requirements of this procedure.
Review of URS.
QA – Validation: Assure that URS required for system or equipment description is complete and current.
Assure that appropriate change control procedures are in place and followed in order to capture and describe changes to logic-controlled systems or equipment utilized for GMP applications.
Review and approve URS wherever applicable.
Quality Assurance: Responsible for ensuring the policies/procedures and compliance to current Good Manufacturing Practice (cGMP) Federal and other applicable regulations.
Accountability: Plant Head and Head – Quality Assurance shall be accountable for implementation and compliance of SOP.
Materials, Equipment and Definitions:
User Department: Department designated as the primary user of a given system/equipment.
Responsible Engineering: Individual primary responsible, from the Engineering perspective, to assure that systems and equipment are designated, purchased, installed and commissioned.
Procedure
URS numbering System:
URS numbering system shall consist of 20 alphanumeric characters i.e. URS/XX/ZZZ-NN/YY description is as follows:
URS: User Requirement Specification
XX: Department Code
ZZZ: URS Serial No.
NN: Version No.
YY: Current Year
For Example: First URS for equipment generated by Production Oral Department in year 2025 shall be as follows: URS/PO/001-00/25.
In case if there is any change required in URS the URS No. shall remain same, but version no. shall change. e.g. suppose first version of URS is URS/PO/001-00/55 for an equipment in year 2014 and there are some changes in URS for same equipment in the same year then the URS No. shall be URS/PO/001-01/25.
All systems and equipment purchased to be utilized for GMP applications shall have associated design documentation that accurately and comprehensively describes the system/equipment requirements, attributes, functionality, construction and operation.
The first step of the design process begins with the conceptualization of a business need. The business need shall be expressed as a formal Conceptual Design document or plan; however, this is not a requirement and is not addressed in the scope of this procedure.
The next step of the design process is the development of a User Requirement Specification (URS). The URS is the primary design document, and while of sufficient detail to describe the system and equipment, also provides an overview of the required / desired functionality. The URS describes what the system or equipment is supposed to do.
An initial version of the URS shall be included with the request for quotation (RFQ) sent to potential suppliers. This version should include all essential requirements and if possible, a prioritized set of desirable requirements.
The URS is typically a key design document for creation of performance qualification test plans.
Prepare the URS content as per Annexure-1.
URS review/approval requirements is as follows:
User Requirement Specification- Required Approval from User Department (Author), Responsible Engineer, QA-Validation, Quality Assurance
Guidelines for Preparation of URS
Some of the supporting information for specific user requirements shall appear in other documents (e.g. Operational/Process descriptions, existing standards). Reference to these other documents should be made where applicable.
Each requirement shall be accurate, clear, consistent, complete and objectively verifiable where possible.
Each requirement shall be uniquely indexed for ease of traceability.
Requirement statements shall neither be duplicated nor contradicted.
All members of the project team and any other stakeholder shall be able to understand the URS. Avoid ambiguity and technical jargon.
Multiple systems sharing the same requirements and same boundaries shall be covered in a single URS document.
Since the URS is used to create criteria for acceptance and define qualification testing of the system, each specification element shall be testable or verifiable in some way.
URS documents shall include the following identification, Organization and approval sections:
- Author(s)
- Effective Date
- Signature/Approval page
- System Name
- Document Name
- Document Identifier and Version
- Table of Contents
The sections to be included in the URS are listed as follows. If there is no requirement specified for a particular section, then the section shall state “Not Applicable” and the reason why the section is not applicable. It is not expected that all of the details listed shall be available for every system.
- Purpose
- Scope
- System Description
- Responsibilities
- Definitions
- Reference Documents
- Functionality
- Data and Reporting
- User Interferences
- System Interfaces
- Constraints/Limitations
- Regulatory and Procedural Compliance
- Environment
- Delivery Requirements
- Safety
- Attachments
- Revision History
A detailed explanation for each of the specified sections listed above is included in Annexure-1.
Acceptance Criteria
Not Applicable
List of Annexure / Formats:
User Requirements Specification For …………………………………………