When is Required a Design Qualification?

CIQA Design Qualification

 

WHAT IS A DESIGN QUALIFICATION DQ?

The Design qualification (DQ) demonstrates that the proposed design (or the existing design for an off-the-shelf item) will satisfy all the requirements that are defined and detailed in the User Requirements Specification (URS). Satisfactory execution of the DQ is a mandatory requirement before construction (or procurement) of the new design can be authorized.

When is Required a Design Qualification?

It is required during the planning stage of the validation system development life cycle of any process, equipment, and facility. It is the first and most important stage to make a good start, defining the user requirements and functional specifications that shall be challenged and tested in further validation stages and activities as Installation, Operational and Performance Qualifications.

The Design Qualification consists of two main documents: URS User Requirement Specification and FRS Functional Requirement Specifications.

URS User Requirement Specifications

The User Requirements Specification 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 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.

FRS Functional Requirement Specifications

The functional requirements specification is 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.

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Why is important the design qualification during an FDA inspection?

It is like an index during the FDA inspection that outlines the validation deliverables involved the qualification activities of your system, equipment, or process.

You can demonstrate that validation activities are in process or pending to executed during an audit inspection, it serves to explain and justify the validation efforts.  If many validation documents and deliverables have to be managed at the same time, then the validation plan serves as a guide and link to correlate all information about each validation deliverable.

Top Benefits of a robust design qualification

In case, a regulatory audit is received before complete some validation work, you can present and show the validation design to demonstrate the due diligence and intention of the company to perform the validation activities as per design requirements and specifications.

 

Three (3) options to create a design qualification.

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

You can download a free sample of a design qualification 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 design qualification.

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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