Definition: User Requirements Specification (URS).
When an end user proposal for either a change to existing equipment or the introduction of new equipment is instigated; it is incumbent on the proposer to produce a list detailing all the attributes and bespoke features essential to the efficacy and safety of the proposal. After approval, this Level 1 URS must be scrutinized by appropriate persons to ensure that all secondary and support requirements to facilities, utilities, training, maintenance, staffing, cGMP, and validation are identified and planned for. On approval, this constitutes Level 2 URS.
User Requirements Specification (URS), can never be described as
a planning tool nor is it mainly used with software - but it is the most often
screwed up of all the compliance documents. Whether the system is purely
mechanical, or 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 an User Requirements Specification
(URS) containing clear, concise and testable requirements.
Once the end-user requirement specification or URS as it is commonly called; 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 the 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 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 which is deemed mandatory for software assessed to be critical to product quality, in the pharmaceutical regulated industries.
Bringing these needs and tasks together in a manner which will verify design fitness for purpose, has traditionally been a tedious and laborious labour. It involved trawling the VP and URS and cross- referencing to the Functional Specification and the Design Specification and the associated Test Specifications, sometimes, with only limited success. The design of our document is unique, it requires the URS to be an active document up to completion of the Design Qualification (DQ). The DQ will be executed against the three level URS, and verify that the code (if there is any) specified in URS Level-3, will deliver the functionality detailed in URS Level-2, which in turn will deliver the operability that the end user specified in URS Level-1.
This document consists of a generic template which uses an attached SOP to allow you to quickly auto-populate the template. It then takes you page by page through the template allowing you to develop the template into your own bespoke company URS. Just ask about validation time that is saved using this simple and quick to produce a quality URS.
The URS is originated by the end user extrapolating requirements directly from the production processes. These high end user requirements are then passed to engineering who are tasked with turning them into a complete procurement package. A package that will include all aspects of purchasing, installing and operating the specified system. Further to these direct requirements there are also a multitude of indirect requirements, such as; documentation, manpower, training and test equipment that must be fully researched, investigated and specified. The URS must be written in a format that allows each of these requirement to be verified as being “fully satisfied” or not.
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 list 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:
User Requirements Specification (URS) Scope includes but is not limited to;
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Why does something as simple as a spreadsheet figure in so many regulatory citations? Good question; and at times a difficult one to answer. When you ask a group of compliance personnel the same question you will be informed that Excel cannot be validated because it does not seal the original copy (of the spreadsheet), allows the original to be modified and has an audit trail that can be disabled. All true, but none of these problems interfere with your ability to validate that the spreadsheet is fit for purpose. They only preclude you from using the spread sheet as a compliant repository for any data that has to be store in compliance with 21 CFR Part 11.
If the spreadsheet is signed off and dated by the user, their supervisor and QA, it becomes regulatory acceptable data stored in hardcopy, and Part 11 does not apply.
After numerous requests for this, we have launched our brand new SOP for Spreadsheet Creation to cover these and other known target points that the regulators consistently hone into as soon as they find that spreadsheets are being used. Use this Spreadsheet Creation SOP to ensure that you create spreadsheets that are validatable. Then use our spreadsheet validation pack to validate them.
SOP for Spreadsheet Creation. -- $125.00
The SOP for Computer Equipment Validation
continues to be an extremely popular document. This document leads you through
the validation process, from the URS to the final P2Q. The Risk and Part 11 Validation Risk Assessment (VRA) protocol is becoming the most important document in the validation train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities.
SOP Equipment Validation.
Purchase your copy now at Special Price of $22.00.
Validation Risk Assessment (Issue11.) -- $125.00
This VRA now includes the assessment table for categorizing and documenting the new 21 CFR Part 11 guidance ruling on what predicate data must be stored in a Part compliant system, along with the new broadsheet to establish your new database of part 11 records. (now mandatory).
The SOP for Computer Equipment Validation continues to be an extremely popular document. This document leads you through the validation process, from the URS to the final P2Q.
The Risk and Part 11 Validation Risk Assessment (VRA) protocol is becoming the most important document in the validation train. The VRA reassures the regulators that you have looked at specific equipment functionality and considered the appropriate level of validation that is required. You have also considered various aspects of its use and the implications of any malfunctions. From the results of this exercise the scope of all validation activity can and must be justified. This is a robust and simple to execute document, one that will lead you through the process and deliver a result that can be used as the foundation for your validation activities.