Edit User Requirements Specification template into your bespoke URS.


User Requirements Specification Template Derivation

The User Requirements Specification template (URS) is meant to  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 user requirements specification template containing clear, concise and testable requirements.

URS Evolution

Once the User Requirements Specification Template is edited into your own company bespoke and approved format and labelled 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 template, 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.


Full life cycle function testing.

Bringing all these user requirements specification template needs and tasks together in a manner which will verify design fitness for purpose, has traditionally been a tedious and laborious labor. 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 User Requirements Specification template. Just ask about validation time that is saved using this simple and quick to produce a quality URS.


User Requirements Specification Template; Justification

Each and every user requirement specification relating to product safety, identity, strength, purity, and quality must be comprehensively identified.

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:

  • Documented verification that the overall design appears to address, by some means, each and every requirement; in the URS, affecting the product and performance of the manufacturing process (or, in the case of 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 User Requirements Specification template.

User Requirements Specification; Scope.

User Requirements Specification template Scope includes but is not limited to;

  • Level-1, full details of end user requirements.
  • Level-2, full details of functionality.
  • Level-3, software functionality interface.
  • A full description of the required system performance.
  • Performance criteria, critical parameters and operating range.
  • Cleaning and maintenance of user requirements.
  • Appropriate regulatory User Requirements Specification template.
  • Documentation User Requirements Specification template.
  • Training user requirements.
  • All none industry standard testing that may be required.



URS and the Software Life Cycle.

This schematic diagram shows the inter-relationship of validation documents that must be followed in a user requirements specification.

User Requirements Specification Template in the Qualification Process.

This schematic shows the basic document inter-relationships.

USER REQUIREMENTS SPECIFICATION template.



Validation Risk Assessment (Issue 11) $125.00

Validation Risk Assessment template (Issue 11) $125.00 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 risk assessment template.

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).



Combined IQ-OQ-PQ Computer (Issue-4) $159.00

This Pharmaceutical Validation 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 procedure TEMPLATE. The associated medical device validation  Master Plan template is interactive, easy to use and suitable for all mixes of equipment with and without software. Where temperature mapping is required it will included in this section. This of course may well be a validation risk Assessment template. As per 21 CFR Part 11.

The Installation Qualification Template or IQ section establishes documented verification that all medical device validation template online executables are catered for and that key aspects of the equipment Qualification adhere to approved design Qualification template and the recommendations of the manufacturer have been suitably considered. The Operational Qualification Template section establishes that there is documented verification that the installed system functions as specified and that there is sufficient documented process validation A 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 medical device validation template; The User Requirements Specification template 



User Requirements Specification (Issue 8) $115.00

This document was designed to be used as a live document up until the DQ is completed and approved. It uses three levels of URS, URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the User requirements specification template through to the final PQ and OQ functionality testing. A mandatory requirement for Full Life Cycle Validation of computer systems and compliance with Current Good Manufacturing Practice legislation. It can be used on mechanical, electrical and software controlled, monitored or driven systems and of course medical device validatioN Template along with the Software Qualification template.



Installation Qualification. SOP & Protocol (Issue 9.) $115.00 10000020

The Standard Operating Procedure template (SOP) used to generate this installation Qualification template (IQ), takes you through the process line by line, chapter by chapter. It really is unique to find a SOP document so easy to use, all the work is done for you. All the documents are detailed, all the drawings listed and all the checks and tests detailed. The final product is a professional and comprehensive Installation Qualification template. One that you can produce in less than 60 minutes. Yes, think about it, we all know how long producing IQ documents has taken in the past, whether for current Good Manufacturing Practice use medical device use or a simple installation qualification template. 



Operational Qualification, SOP & Protocol (Issue 10.) $115.00 

You will find the Operational Qualification template (OQ) delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific 21 CFR Part 11 compliant Installation  Qualification Template. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol, along with the installation qualification template.



Operational Qualification, SOP & Protocol (Issue 10.) $115.00 10000025

You will find the step by step attached SOP delightfully simple and straightforward to use, as it takes you through the process of customization of your Operational Qualification Protocol template. Following the attached SOP will quickly and smoothly convert your template into an equipment specific Operational Qualification Protocol. The OQ template comes complete with all the standard test scripts, more specialist test scripts can be found listed below. These can easily be pasted into the standard OQ, allowing you to quickly build your own fully detailed and referenced company bespoke Operational Qualification Protocol.




Equipment combined IQ/OQ/PQ Protocol.
$159.00

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 template is interactive, easy to use and suitable for all mixes of equipment with and without software. This of course may well be a validation Plan template.

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 Qualification template 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 User Requirements Specification template.

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