Favored by regulators, auditors & agencies. Reduces costs. Delivers Consistent Quality Results User Requirement Specification template arrives ready for you to edit into your own company bespoke, FDA compliant protocol.
Learn how to prepare a User Requirements Specification template (URS) that will streamline your whole validation task. No matter 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 URS containing clear, concise and testable requirements.
Once the end user requirements specification template 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 requirements 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 User Requirements Specification template 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 User Requirement 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 User Requirements Specification template Level-2, which in turn will deliver the operability that the end user requirements 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 User Requirements Specification Template 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 packages. 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 User Requirements Specification must be written in a format that allows each of these user requirements to be verified as being “fully satisfied” or not.
Each and every requirement listed in a User Requirements Specification template relating to product safety, identity, strength, purity, and quality must be comprehensively 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 user requirement that can affect the above product or process attributes (e.g., cGMP’s).
Given a comprehensive User Requirements Specification template 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 template Scope includes but is not limited to;