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. There 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.
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Users should also give the details of other areas that are going to be affected if the machine is procured, or the other areas that need to be modified, 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 like a 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 the machine like Metal detectors, Camera inspection systems, pinhole detectors, 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
- 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.
The URS includes all the requirements that the process or system must meet. Either developed by the user alone or with the help of the vendor with approval from Quality. The various requirements mentioned in this document include:
- Automation Requirements such as alarms, interlocks, and process control
- Safety requirements such as fail-safe conditions, safety interlocks
- Electrical Requirements
- Regulatory Requirements
- Process Flow Chart
- Technical Requirements
- System Component Details
- Preferred suppliers
- Documentation
- User Requirements Specification (URS) is the most critical of documents and yet, the most often bungled. Whether the system is purely mechanical, a mix of electro-mechanical, or solely a software program, the successful compilation and execution of the Installation Qualification (IQ) (for installation), Operational Qualification (OQ) (for functionality), and the Performance / Product Qualification (PQ) (for operability), is dependent on a User Requirements Specification (URS) containing clear, concise and testable requirements.
- Once the end-user requirements specification is documented, agreed and approved they form the basic URS Level-1 document. The engineers (or vendor) can then commence the preliminary design to establish exactly what functions are required for each of the items specified in the user requirements specification, the end-user has listed. Once this functionality is documented and approved it forms a URS Level-2 document.
- This is the final level of the URS unless software is used. If software is to be used, the URS Level-2 document is passed to the code writers. As the code is written, lines, or groups of lines, of code must be attributed to the individual functions that necessitate their presence. The completion of this task results in the completion of the URS Level-3 document.
- Developing the URS to this level is unique in most industries, but is, standard practice in strictly regulated industries, as it is a major building block in the creation of quality software. The URS Level-3 document contains all the traceability that is deemed mandatory for software assessed to be critical to product quality, in pharmaceutical-regulated industries.
- The URS can contain a large number of requirements and should therefore be structured in a way that will permit easy access to information. The requirement specification must be formally reviewed and approved by the pharmaceutical manufacturer.
- The following guidelines should be followed during the production of the URS:
- Each requirement statement is to be uniquely referenced, and no longer than 250 words.
- Requirement statements should not be duplicated or contradicted.
- 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 should be avoided.
- The use of diagrams is often useful.
- The scope for readers to make assumptions or misinterpret should be minimized.
- Wherever possible, the URS should distinguish between mandatory/regulatory requirements and desirable features.
The URS for a GMP computer control system application will typically address the following:
- Scope of system supply
- Objectives
- Regulatory requirements
- Process overview
- System boundaries
- Operational considerations
- Manufacturing design data
- Instrument application data
- Data Records
- The system functions System software
- System hardware and peripherals
- System interfaces Environmental conditions Access security Diagnostics System availability Safety Test and calibration
- Quality procedures Software development life cycle Documentation requirements Training
- Engineering/installation standards Ongoing support Warranty Delivery/commercial requirements
Newly sanctioned systems will require compliance with regulations for GMP electronic records and electronic signatures, and a definition of the functionality required will need to be included. The structure of the URS be used as the basis for the presentation format of the FDS and hardware and software design specifications; this helps ensure design decisions are auditable back to the source requirement. Once reviewed and approved internally, the URS is issued to prospective suppliers as part of the tender document set so that detailed quotations for the system application can be obtained.
URS provides the following key benefits for the validation program:
- Clarifies technical, quality, and documentation requirements to the vendor(s).
- Enables the pharmaceutical manufacturer to assess the technical, regulatory, and commercial compliance (or otherwise) of submitted bids against formal specifications.
- Ensures the basis of a structured approach to the presentation of information.
- Provides a basis for testing and test acceptance criteria.
- Provide a baseline for validation and certification.
They must be comprehensive. Each and every requirement relating to product safety, identity, strength, purity, and quality must be identified. Hence, Quality Assurance (QA) must have a significant role in reviewing and approving the final set of requirements and must be an approver of changes to any requirement that can affect the above product or process attributes (e.g., cGMP ’s).
Given a comprehensive User Requirements Specification that has been approved by QA and is under project change management, the Design Qualification (DQ) process then can be reduced to two key objectives:
- Documented verification that the overall design appears to address, by some means, each and every requirement affecting the product and performance of the manufacturing process (or, in the case of an unknown product or multi-product manufacturing facility, the required equipment system performance capabilities).
- Identification (and documentation) of the critical individual physical components, attributes, and operational features that directly support meeting each requirement.
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