DESIGN QUALIFICATION (DQ).


Design Validation customer city skyline photograph.  This one is Montreal.Boston.

Design Qualification Definition.

Procurement procedures must ensure that all designs tendered from Requests for Quotations for equipment destined to be used in the production of a 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 Rationale.

A Design Qualification 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 major project problems are manufactured, not obvious immediately, but materializing later in the project time line.

The Design Qualification is the only 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 Validation Protocol 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 Of - The - Shelf. A Design validation 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.


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DQ Scope.

The scope of the Design Validation protocol must include but is not limited to:

  • Verification that the design will achieve the URS requirements.
  • 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 complies with the VMP.
  • 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 calibratable.
  • 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 system 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.

PERFORMANCE QUALIFICATION.


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SOP for Spreadsheet Creation.

Why does something as simple as a spreadsheet figure in so many regulatory citations? Good question; and at times a difficult one to answer. When you ask a group of compliance personnel the same question you will be informed that Excel cannot be validated because it does not seal the original copy (of the spreadsheet), allows the original to be modified and has an audit trail that can be disabled. All true, but none of these problems interfere with your ability to validate that the spreadsheet is fit for purpose. They only preclude you from using the spread sheet as a compliant repository for any data that has to be store in compliance with 21 CFR Part 11.
If the spreadsheet is signed off and dated by the user, their supervisor and QA, it becomes regulatory acceptable data stored in hardcopy, and Part 11 does not apply.
After numerous requests for this, we have launched our brand new SOP for Spreadsheet Creation to cover these and other known target points that the regulators consistently hone into as soon as they find that spreadsheets are being used. Use this Spreadsheet Creation SOP to ensure that you create spreadsheets that are validatable. Then use our spreadsheet validation pack to validate them.

SOP for Spreadsheet Creation. -- $125.00

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SOP Equipment Validation.

The SOP for Computer Equipment Validation continues to be an extremely popular document. This document leads you through the validation process, from the URS to the final P2Q.


Purchase your copy now at Special Price of $22.00.

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Validation Risk Assessment (Issue11.) -- $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 activities.
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).

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