Author Question: Validation is defined as a. conformance of a product or process with pre-established ... (Read 30 times)

jrubin · **on:** Jun 25, 2018

Validation is defined as

a. conformance of a product or process with pre-established specifications
b. documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting predetermined specifications
c. monitoring performed to ensure that the quality system is being adhered to and is effective
d. standardization of an analytic instrument

Question 2

Which type of audit is particularly effective in spotting errors that may be overlooked by routine record review?

a. External
b. Process
c. Product
d. Self