"Value" and "Overhead(s)" of implementation of "CSV

**v9991** · #1 21st November 2009, 04:57 AM

"value" and "over head[s]" of implementation of "CSV - validation requirements" in automation projects [regulated industries].

1) How would you "measure"/"quantify" the "value" of implementing "CSV". [looking for something beyond Cost of quality...et.,c something, which should convince the shop-floor/dev-team adopt/implement the process]

2) What are the "over head[s]" in the current implementation process.
[like somebody commented that, with CSV process, the project would take almost twice as long to complete...--> time overhead.]

3) what is the cause of these overheads and what are the processes/activities which can be simplified/optimized.

**Marcelo Antunes** · #2 22nd November 2009, 06:31 PM

Hello

Just to clarify, CSV means computer system validation, right? Sometimes people do not give answers because they do not understand the acronyms..

Anyway, i thiink this thread will be better located in the Qualification and Validation forum, i´ll move it there.

Let´s wait to see if anyone can give thoughts.

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