How to build a Functional Requirement Specifications FRS.

Functional Requirement Specifications

 

WHAT IS A FUNCTIONAL REQUIREMENT SPECIFICATIONS FRS?

The functional requirements specification (FRS) document contains a description of the software product to be supplied in terms of the functions it will perform and facilities required to meet the user requirements (often defined in a prior URS – User Requirements Specification) document.

Software validation typically has a Functional Requirement Specifications (FRS) that follows the URS in a logical, traceable way. The FRS shows the way the software post-configuration as per developer company recommendations will meet the requirements of the URS.

The Functional Requirements Specification documents the operations and activities that a system must be able to satisfy each individual URS user requirement, described for example as:

  • Interface requirements
  • Business Requirements
  • Regulatory/Compliance Requirements
  • Security Requirements

In other words, all requirements outlined in the User Requirement Specification should be addressed in the Functional Requirements Specification.

The FRS should include the following sections: (as applicable)

  • Purpose
  • Scope
  • Background
  • Hardware and Software Description
  • Descriptions of data to be entered into the system
  • Descriptions of operations performed by each screen
  • Descriptions of work-flows performed by the system
  • Descriptions of system reports or other outputs
  • Who can enter the data into the system
  • How the system meets applicable regulatory requirements
  • The Functional Requirements Specification is designed to be read by a general audience. Readers should understand the system, but no particular technical knowledge should be required to understand the document.
  • Associated Reference Documents
  • Appendices
  • History of Change
  • Document Approval

Depending on the scope and complexity of the program, the FRS document can be combined with the user requirements specification in just one document design specification document.

Requirements outlined in the Functional Requirements Specification are usually tested in the Operational Qualification.

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Three (3) options to create an FRS Functional Requirement Specifications

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

You can download a free sample of a functional requirement specification 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 a customized functional requirement specification.

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.

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References

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=225.1

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

https://ispe.org/publications/guidance-documents/gamp-5

http://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf

https://www.fda.gov/media/94074/download

http://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf

https://www.fda.gov/media/94074/download

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=225.1

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

https://ispe.org/publications/guidance-documents/gamp-5

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

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!

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