Design and Development Validation

GOOD VALIDATION PRACTICE (cGVP)
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How should we carry out design and development validation

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:confused:

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Hi basavaraj,

Can you be more specific with this question.

Tks

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i works for one of the architecure and infrastructure development company. i am a Q.A.Coordinator. i want to audit the design and development department. so i want to know the method of validation

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Hi Basavaraj,
Please elaborate your question.

Thanks

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[quote=Shahnawaz]Hi Basavaraj,
Please elaborate your question.

Thanks[/quote]

we are into design consultancy(architectural design, structural and also interior desin), as per the ISO 9001:2000QMS clause 7.3.6 design and development validation.how shall we carry out deign validation. pls explain in detail.

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Boiled down, design verification is confirmation with objective evidence that an output conforms to specifications. Design validation is confirmation with objective evidence that a product conforms to what the user wants.

What are your inputs (specifications?)? Those inputs get transformed, possibly multiple times, eventually resulting in your product (outputs). Design verification is the process to show that your outputs were sufficiently transformed to implement the inputs. Design validation is then confirmation that the output is what the customer wanted.

I’m reminded of the “swing project.” It’s better presented visually but I don’t have the picture. Essentially, the customer wants a swing hanging from a tree (input). A swing was designed that hung from the branches but straddled the tree. This could be said to meet requirements but was obviously non-functional.

One source for design validation might be whatever the customer does to accept the outputs.

Hope this helps.

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i want to know the the method for design and development validation.