Whose conducting your Quality Audits?

21 CFR 820.22 states: Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. 

A medical device company recently received this 483 observation: 

…..Individuals who conduct quality audits have direct responsibility for the matters being audited.

Specifically, your Vice President of Regulatory Affairs indicated that she is responsible for conducting all areas of your firm’s quality system audit, including the departments that she is directly responsible for.

For more details on this observation as well as other observations pertaining to Medical Device Manufacturers see Issue 1016 available today.  It features observations pertaining to Data Integrity on our rotating page 3 topic as well as Laboratory Controls and Manufacturing Controls.

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