Definition: User Requirements Specification (URS).
URS-level 1 = End user needs: URS-Level 2 = Executables + Training + Facility needs. URS-Level 3 = Software functionality in Level 1.
Learn how to prepare a User Requirements Specification (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 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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This combination protocol has been produced in response to several
hundred reader suggestions we received in our ‘Suggestions Section’. It
has been carefully designed to make it the preferred choice for Process
and Laboratory stand alone equipment and associated standard operating procedures. The associated Validation Master Plan is interactive, easy to use and
suitable for all mixes of equipment with and without software.
The IQ section establishes documented verification that all validation Online executables are catered for and that key aspects of the equipment adhere to approved design intentions and the recommendations of the manufacturer have been suitably considered. The OQ section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation executables to demonstrate this. The PQ section develops documented evidence that all the requirements specified in your corporate validation 4U manual have been verified as operating consistently and exactly as specified in the URS.
The Process Validation or Qualification is the culmination of the validation process. The protocol is used in conjunction with the SOP for the process, to run three batches through the process being qualified and verify that the process consistently produces product to within the process specified tolerances. The results of the process must be recorded and reviewed with a view to ensuring that the deviances (within permitted tolerances) that exist are random and not a trend that could lead to out of specification produce being produced.
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This Validation 4U, Risk & Requirements Plan (VrrP) is one document designed specifically to replace three. The contents of the three original documents were completely revised and edited into a more compact and interactive format. This new format will make a significant difference to the man hours required to produce and execute these standard operating practice process validation master plan executables. There will also be a very noticeable reduction in the time required for the reviewing and approving tasks. This new document titled the VrrP replaces the VP, VRA & URS and now compliments our equally new 4Q Protocol, which integrates the DQ/IQ/OQ/PQ into one document.
This is an essential step forward for companies seeking to reduce validation 4U costs whilst remaining compliant with their Corporate Validation Manual.
4Q Equipment Validation 4U Protocol (4Q-Equip) has been designed specifically to replace four standard protocols. By taking the contents of the four protocol and carefully weaving them into one notably easy to use protocol, we have made a significant advance in the task of streamlining process validation Online executables documentation and associated standard operating procedures, by reducing protocol numbers by close to 75%. The new bang up to date 4Q protocol replaces the DQ, IQ, OQ & PQ and now compliments our equally new VrrP Protocol. By integrating the old style DQ/IQ/OQ/PQ into one 4Q document there will be enormous savings in man hours in the authoring, reviewing, updating and approving tasks.
For everyone's convenience, the Corporate Validation 4U Manual template is written in written in word.