How to create an User Requirement Specification URS.

CIQA User Requirement Specifications



The User Requirements Specifications describes the business needs for what users require from the system.  The URS is generally a planning document, created when a business is planning on acquiring a system and is trying to determine specific design needs.

User Requirements Specifications are written early in the validation process, typically before the system is created. They are written by the system owner and end-users, with input from Quality Assurance.

The user requirement(s) specification (URS) is a document usually used in computer system validation that specifies what the user expects the software to be able to do as part of the Design Qualification DQ.

Once the required information is completely gathered it is documented in a URS, which is meant to spell out exactly what the software must do and becomes part of the contractual agreement. A customer cannot demand features not in the URS, while the developer cannot claim the product is ready if it does not meet an item of the URS.

The URS can be used as a guide to planning cost, timetables, milestones, testing, etc. The explicit nature of the URS allows customers to show it to various stakeholders to make sure all necessary features are described.

Formulating a URS requires negotiation to determine what is technically and economically feasible. Preparing a URS is one of those skills that lies between a science and an art, requiring both software technical skills and interpersonal skills.

The URS facilitates a starting point and traceability to ensure that basic functions are established. These basic functions will be used later for assessing risks.

The further preparation of the risk assessments, Functional Requirement Specifications FRS, and execution of the Installation Qualification (IQ), Operational Qualification (OQ), and Performance / Product Qualification (PQ), is dependent on a URS containing clear, concise, and testable requirements.

User Requirements Specification (URS) document should include the following parts and sections: (as applicable);

o   Purpose

o   Scope

o   Background

o   Hardware and Software Description

o   Level-1, full details of end-user operability.

o   Level-2, full details of functionality.

o   Level-3, software functionality interface.

o   A full description of the required system performance.

o   Performance criteria, critical parameters, and operating range.

o   Cleaning and maintenance requirements.

o   Appropriate regulatory requirements.

o   Documentation requirements.

o   Training requirements.

o   All industry-standard testing that may be required.

o   Associated Reference Documents

o   Appendices

o   History of Change

o   Document Approval

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Three (3) options to create a User Requirement Specification.

Option 1. You can create a great protocol, using a template.

You can download a free sample of a user requirement specifications template in .pdf format. 

To see the complete list of the most popular validation templates, click here.

In addition, you can request a quotation to buy online a full validation template document in MS Word format that is completely editable, ready to fill, and adapt to your needs.

Option 2. We can bring you a formal training on how to create your own validation protocols using our template(s).

This option is recommended if you want to learn more about how to build a robust validation protocol. One of our expert(s) will provide online step-by-step training to your team (unlimited assistance) on how to build a reliable validation protocol using a template. You can improve your corporate validation procedures and policies incorporating our template sections.  It includes the template, an exam, and a training certificate for each assistant.  Request a quote now.

Option 3. We can create customized user requirement specifications.

One of our expert(s) will create and prepare for you a customized validation protocol with the inputs and specific information of your company. It may include, online support in document creation, execution, or final reporting, Request a quote online.











Related topics and resources:

Validation Plan, Installation Qualification, Operational Qualification, Performance Qualifications, Component Qualification, Traceability Matrix, Ppk, Control Charts, Cpk, User Requirements, Functional Requirement Specifications, GAMP5, risk assessment

Picture of Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!