Design Qualification Template

Edit Design Qualification template into Bespoke Protocol

Design Qualification Template Defined.

Current Design Qualification template must always be included in all requests for quotations for equipment destined to be used in the production of cGMP controlled product are subjected to the rigors of Design Qualification analysis.  In a similar manner; any “off-the-shelf” items being considered, must be subjected to a similar analysis to verify that their existing design specification is equal to; or better than, the required design specification.   


Design Qualification Template Rationale.

It must be authored and executed by suitably qualified persons  who are knowledgeable enough to challenge the proposed design.

A Design Qualification template protocol is used at the stage where a design that has been developed from the, VMP / URS /GAMP 5 / cGMP / and other Health and Safety Guidelines, is reviewed and documented by competent persons to ensure that the designed equipment, if built, will satisfy all the detailed specified requirements, as contained in the VP and URS.

I have written before in these documents that certain things are critical, well here we are again. You have taken great trouble to write, and have approved, a URS and a VP, now a vendor (or could be in house) has come forward and presented a design that they have prepared, and they state it will satisfy your requirements. This is where the majority of project validation problems evolve from;  not immediately apparent, but materializing later in the project time line.

The Design Qualification template is the major document that is going to confirm that the design will work. It must be authored and executed by suitably qualified persons  who are knowledgeable enough to challenge the proposed design and its  performance. If you have no such persons on your staff you must contract them in, or contract the authoring of the Design Validation protocol out.

When I arrive on site to manage a project, my very first task is always to get to grip with the design, get all the drawings and review them. I do this because thirty years of experience has made me very aware, that I need to know the design is good. So often; this is not the case, and very often there are glaring abnormalities. When these are highlighted with the client and their vendors, only the vendors are smiling. The client had accepted the design and the vendor had quoted for that design, any changes will be extra to the quoted price. Sometimes this has run into seven figures.

A PROPER DESIGN QUALIFICATION IS ESSENTIAL TO YOUR HEALTH.

A Design Qualification template can also be used where a company has prepared a User Requirements Specification (URS) for a piece of equipment and is searching for a manufacturer, but is offered equipment "Off-The-Shelf". A Design Qualification template can be used to verify whether the "off-the-shelf" item will fully deliver the functionality detailed in the URS, and conform to the requirements specified in the VMP / cGMP while complying with all applicable Health and Safety Notices.


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Design Qualification Template Scope.

A Design Qualification template  is used at the stage where a design that has been developed from the, VMP / URS / cGMP / and other Health & Safety Guidelines, is reviewed and documented by competent persons to ensure that the designed equipment, if built, will satisfy all the detailed specified requirements, as contained in the VP and URS.

I have written before in these documents that certain things are critical, well here we are again. You have taken great trouble to write, and have approved, a URS and a VP, now a vendor (or could be in house) has come forward and presented a design that they have prepared, and they state it will satisfy your requirements. This is where the majority of project validation problems evolve from; not immediately apparent, but materializing later in the project time line.

The Design Qualification template is the major document that is going to confirm that the design will work. It must be authored and executed by suitably qualified persons who are knowledgeable enough to challenge the proposed design and its performance. If you have no such persons on your staff, you must contract them in, or contract the authoring of the Design Validation protocol out.

When I arrive on site to manage a project, my very first task is always to get to grip with the design, get all the drawings and review them. I do this because thirty years of experience has made me very aware, that I need to know the design is good. So often; this is not the case, and very often there are glaring abnormalities. When these are highlighted with the client and their vendors, only the vendors are smiling. The client had accepted the design and the vendor had quoted for that design, any changes will be extra to the quoted price. Sometimes this has run into seven figures.

A Design Qualification template can also be used where a company has prepared a User Requirements Specification (URS) for a piece of equipment and is searching for a manufacturer, but is offered equipment "Off-The-Shelf". A Design Qualification protocol can be used to verify whether the "off-the-shelf" item will fully deliver the functionality detailed in the URS, and conform to the requirements specified in the VMP / cGMP while complying with all applicable Health and Safety Notices. 

Verification that the design is cGMP compliant, and where software is used; conforms to the life cycle model requested in the VP and detailed in GAMP 5. 

Verification that the design qualification template complies with the VMP. 

Verification that all the required support documentation is specified. 

Verification that the system will be calibratable 

Verification that the design will achieve the URS requirements. 

Verification that the utility services required are available and validated.  

Verification that all the required support documentation is specified. 

Verification that the system will be maintainable. 

Verification of operation staff training requirements. 

Verification that the system will operate in a manner safe to both product and staff. 

Verification that the design qualification template conforms to all applicable national standards and guidelines. 


DQ in the Validation Process.

This graphic is a schematic of the inter-relationships of Design Qualification documentation.

DESIGN QUALIFICATION.



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 



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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.



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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.



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The User Requirements Specification template is the document that sets the standard, and specifies your requirements in a manner that ensures when a system or piece of equipment is selected for cGMP use that all essential support elements; i.e. maintenance, parts, operator & maintenance training, are planned and budgeted for.  It uses three levels of User Requirements Specification Template (URS), URS Level 1, 2 and 3, and is the only URS to guarantee traceability from the URS through to the final OQ and PQ functionality testing. A requirement mandated by cGMP regulations. It can be used on mechanical, electrical and software controlled, monitored or driven systems. 



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