The User Requirements Specification (URS) is the initial document that establishes the quality and regulatory compliance of all instruments, machines and systems in the pharmaceutical industry, well before the actual use of equipment or implementation of systems.
A URS outlines "what" the user wants from the equipment or system; it does not indicate "how" those requirements should be met. The URS acts as a mediator between the expectations of the user and the design provided by the supplier. The URS is a critical component of both validation and qualification processes for all types of equipment, instruments and computerized systems.
This article provides an overview of the concept, structure and regulatory significance of User Requirement Specifications within pharmaceuticals, as well as providing information and assistance on writing a suitable URS document.
A URS is created as the first step in the qualification and validation process. It serves as a guideline for the subsequent steps of the process — design, procurement, testing and acceptance.
The URS defines:
What is required from the system?
What environments will the system work in?
What regulatory or GMP regulations apply to the system?
1. Clearly Define Expectations: A URS helps the supplier understand exactly what the requirements are for a given system.
2. Provides the Basis for Design: The design qualification (DQ) process is used to verify that the design of the proposed system meets all of the requirements in the URS.
3. Ensures Compliance with Regulations: The URS will contain all of the requirements necessary for compliance with Good Manufacturing Practices (GMP), data integrity and 21 CFR Part 11.
4. Facilitates Risk Assessment: The URS provides an avenue to help identify which functions have the highest level of risk regarding product quality.
5. Functions as a Reference during Validation: All functional test, site acceptance test, installation qualification, operational qualification and performance qualification testing can all be traced back to the URS.
6. Improves Communication: The URS is used as a common point of reference among users, suppliers, quality assurance and validation when discussing the functionality of an item.
The lack of a well-defined URS can lead to vagueness when qualifying equipment, resulting in excessive costs associated with redesigning and qualifying the equipment due to lack of clarity and compliance issues.
1. EU GMP Annex 11: Computerized Systems states that “User requirements must specify what functions, performance and security are expected from the system.”
2. GAMP5 states that URS is the first and most important input into the system's lifecycle.
3. FDA 21 CFR 211 & 11 implies that systems must have documented requirements and that must meet GMP and data integrity requirements.
Because of this, the URS must be treated as a required control document for GMP that supports both the qualification of a system as well as regulatory inspections.
Common examples of what will require a URS are:
1) Equipment used for manufacturing including compression and coating machines, RMG, blenders, FBD, filling machines, reactors and autoclaves.
2) Scientific analytical equipment like HPLC, GC and UV-Visible spectrophotometers.
3) Environmental monitoring systems.
4) Utilities (purified water and air conditioning).
5) Computerized systems (LIMS/SCADA/MES).
Example: "This URS defines the design and technical requirements for the purified water generation system that will be installed in the utility area of the company."
Example: "This URS addresses all hardware, software, control panels and interfaces with current utilities, but does not address any piping installations beyond the utility interface."
- EU GMP Annex 15
- 21 CFR Part 11
- GAMP 5
- Any relevant ISO Standards
- The system will provide purified water that meets USP requirements.
- The system will log all user activity (i.e., date & time).
- Flow rates, temperatures, pressures and analytical ranges etc.
- Speed of data processing for software systems.
- User access controls, user roles and responsibilities and password requirements.
- Audit trails, electronic records and electronic signatures requirements.
- Data backup, recovery and storage methods.
Download Sample URS
1. Use language that is clear and easy to understand without any uncertainty and ensure that requirements are measurable and can be tested by demonstrating the fulfillment of the requirement.
2. Do not influence the design of the product development and specify what you need, but not how you will get it.
3. A unique traceability numbers should be assigned to each individual user requirement specification like URS-001, URS-002 etc.
4. Include input from different concerned departments within the company like production, quality assurance and engineering to ensure review and approval of all requirements.
5. Establish a link between requirements and risk assessments that identifies those that are critical to product quality.
6. Obtain formal approval from the quality assurance department before using the URS for qualification.
2. Minimize project delays due to unavailability of equipment details and duplicate work efforts.
3. Enhance regulatory compliance with good manufacturing practice (GMP) and readiness for regulatory inspections.
4. Provide the foundation for design qualification of the equipment or system.
5. Support unbiased decision making for acceptance and qualification.
2. Using a requirement that cannot be substantiated or is non-specific.
3. Missing GMP, data integrity or safety considerations.
4. Not involving QA or validation people when preparing the URS document.
5. Failing to modify or update the URS after design and process modifications.
After avoiding these mistakes, you will have a URS that continues to be a trusted document - accurate, up-to-date and compliant with regulations.
The User Requirement Specification (URS) forms the basis for all compliant pharmaceutical systems. The URS describes the user requirements, provides direction for the design, supports the validation process, and provides evidence of compliance during audits.
A properly prepared and organized URS will not only assist in ensuring product quality, but will also provide proof of the company’s commitment to regulatory excellence. A good URS will establish product quality right from the starting.
This article provides an overview of the concept, structure and regulatory significance of User Requirement Specifications within pharmaceuticals, as well as providing information and assistance on writing a suitable URS document.
What is a User Requirement Specification (URS)?
The User Requirement Specification (URS) is a legal document that articulates the user’s expected performance, operations and regulatory compliance for a particular software, system or equipment in the pharmaceutical environment.A URS is created as the first step in the qualification and validation process. It serves as a guideline for the subsequent steps of the process — design, procurement, testing and acceptance.
The URS defines:
What is required from the system?
What environments will the system work in?
What regulatory or GMP regulations apply to the system?
Purpose of URS in Pharmaceuticals
The URS for pharmaceuticals is defined in a number of different critical purposes.1. Clearly Define Expectations: A URS helps the supplier understand exactly what the requirements are for a given system.
2. Provides the Basis for Design: The design qualification (DQ) process is used to verify that the design of the proposed system meets all of the requirements in the URS.
3. Ensures Compliance with Regulations: The URS will contain all of the requirements necessary for compliance with Good Manufacturing Practices (GMP), data integrity and 21 CFR Part 11.
4. Facilitates Risk Assessment: The URS provides an avenue to help identify which functions have the highest level of risk regarding product quality.
5. Functions as a Reference during Validation: All functional test, site acceptance test, installation qualification, operational qualification and performance qualification testing can all be traced back to the URS.
6. Improves Communication: The URS is used as a common point of reference among users, suppliers, quality assurance and validation when discussing the functionality of an item.
The lack of a well-defined URS can lead to vagueness when qualifying equipment, resulting in excessive costs associated with redesigning and qualifying the equipment due to lack of clarity and compliance issues.
Regulatory Importance of URS
Regulatory bodies, including the US FDA, EMA and WHO have stated clearly that user requirements must be defined and traceable before validating a computerized system.1. EU GMP Annex 11: Computerized Systems states that “User requirements must specify what functions, performance and security are expected from the system.”
2. GAMP5 states that URS is the first and most important input into the system's lifecycle.
3. FDA 21 CFR 211 & 11 implies that systems must have documented requirements and that must meet GMP and data integrity requirements.
Because of this, the URS must be treated as a required control document for GMP that supports both the qualification of a system as well as regulatory inspections.
When is a URS Required?
The Use Requirements Specification (URS) will be created before purchasing, developing or implementing significant equipment, utilities, instrumentation or computerized systems that may have either a direct effect or an indirect effect on the quality of a manufactured product.Common examples of what will require a URS are:
1) Equipment used for manufacturing including compression and coating machines, RMG, blenders, FBD, filling machines, reactors and autoclaves.
2) Scientific analytical equipment like HPLC, GC and UV-Visible spectrophotometers.
3) Environmental monitoring systems.
4) Utilities (purified water and air conditioning).
5) Computerized systems (LIMS/SCADA/MES).
Structure of a User Requirement Specification
In the pharmaceutical industry the URS typically has these sections:1. Introduction
A brief description of the system including the purpose and its use.Example: "This URS defines the design and technical requirements for the purified water generation system that will be installed in the utility area of the company."
2. Scope
Identifies the requirements that are required to include or exclude.Example: "This URS addresses all hardware, software, control panels and interfaces with current utilities, but does not address any piping installations beyond the utility interface."
3. System Description
This section will provide an detailed overview of the system or equipment including its components and primary functions.4. Regulatory and Compliance Requirements
Provide a list of relevant regulations and standards includes:- EU GMP Annex 15
- 21 CFR Part 11
- GAMP 5
- Any relevant ISO Standards
5. Functional Requirements
The functional requirement describes what the equipment or system will do, such as:- The system will provide purified water that meets USP requirements.
- The system will log all user activity (i.e., date & time).
6. Performance Requirements
Performance requirements describe measurable outputs, including:- Flow rates, temperatures, pressures and analytical ranges etc.
- Speed of data processing for software systems.
7. Safety and Environmental Requirements
Safety and environmental requirements detail for the equipment, alarms, interlocks and safety systems those are necessary to prevent accidents or contamination.8. Data Integrity and Security
The data integrity and security address the following for computerized systems:- User access controls, user roles and responsibilities and password requirements.
- Audit trails, electronic records and electronic signatures requirements.
- Data backup, recovery and storage methods.
9 Calibration and Maintenance
Describes frequency of calibration, maintenance requirements and spare parts.10 Documentation Requirements
The suppliers must provide user manuals, design drawings, material certificates, FAT protocol and SAT protocols.11 Training Requirements
Training is to be provided for the operation, maintenance and QA personnel.12 Acceptance Criteria
Describes methodology for verifying compliance with each requirement (FAT, SAT or OQ).13 Approval and Sign-off Signature
This section contains preparation, review and approval by user, engineering, validation and QA.Download Sample URS
Creating an Effective User Requirement Specification (URS)
The best practices listed below those provide a foundation for increasing clarity, accuracy and completeness of your URS.1. Use language that is clear and easy to understand without any uncertainty and ensure that requirements are measurable and can be tested by demonstrating the fulfillment of the requirement.
2. Do not influence the design of the product development and specify what you need, but not how you will get it.
3. A unique traceability numbers should be assigned to each individual user requirement specification like URS-001, URS-002 etc.
4. Include input from different concerned departments within the company like production, quality assurance and engineering to ensure review and approval of all requirements.
5. Establish a link between requirements and risk assessments that identifies those that are critical to product quality.
6. Obtain formal approval from the quality assurance department before using the URS for qualification.
Benefits of a Perfect User Requirement Specification
1. Establish clarity about the equipment or system and reduces the possibilities of misunderstandings between the user and the vendor.2. Minimize project delays due to unavailability of equipment details and duplicate work efforts.
3. Enhance regulatory compliance with good manufacturing practice (GMP) and readiness for regulatory inspections.
4. Provide the foundation for design qualification of the equipment or system.
5. Support unbiased decision making for acceptance and qualification.
Common Mistakes in URS Preparation
1. Using a generic template, without customizing it for your facility.2. Using a requirement that cannot be substantiated or is non-specific.
3. Missing GMP, data integrity or safety considerations.
4. Not involving QA or validation people when preparing the URS document.
5. Failing to modify or update the URS after design and process modifications.
After avoiding these mistakes, you will have a URS that continues to be a trusted document - accurate, up-to-date and compliant with regulations.
The User Requirement Specification (URS) forms the basis for all compliant pharmaceutical systems. The URS describes the user requirements, provides direction for the design, supports the validation process, and provides evidence of compliance during audits.
A properly prepared and organized URS will not only assist in ensuring product quality, but will also provide proof of the company’s commitment to regulatory excellence. A good URS will establish product quality right from the starting.
Responsibility as per expert including equipment owner should write URS,put addition input of engineering point of view and again QA shall review for compliances as per regulatory requirements.
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