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#1
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What parameters should be checked in DQ document for an equipment having PLC controls? What design parameters to be checked for PLC?
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#2
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Can you expand on what you mean by Design Qual
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#3
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The Design Qualification (DQ) is executed as the final verification that the Design Specification (DS) will deliver the requirements that the end user has detailed in the User Requirement Specifications (URS), and that the design is compliant with all applicable regulatory, company, health and safety requirements. Therefore you must verify every aspect of the design.
With ‘Off the Shelf’ equipment or software, it must be used to verify that the proposed purchase can fulfil all the end user requirements as detailed in the URS. It cannot be over-emphasizes just how important the DQ is. There are many horrendous blunders perpetuated by some really clever dedicated individuals, which would have been caught at DQ level, if there had been one. Alex Kennedy CEO www.validation-online.net |
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#4
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What is mentioned in a design Qualification?
tell me if a software is developed in-house then the developer should provide the functional specifications and the design specifications? Are these functional specification and design specification to be included in the design qualification. Please reply to this.
__________________
Dinesh K Pai [/SIZE][/FONT]
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