Re: Re: "Legality" of revising QA records

[yvette_lloyd@bio-rad.com]

Subject: Re: Re: "Legality" of revising QA records
Author:  Yvette Lloyd at IRVINE
Date:    2/28/01 1:36 PM


     This may not be applicable to your situation, but 21 CFR 58.185 (c) 
     provides:
     
     'Corrections or additions to a final report shall be in the form 
     of an amendment by the study director. The amendment shall clearly 
     identify that part of the final report that is being added to or 
     corrected and the reasons for the correction or addition, and shall be 
     signed and dated by the person responsible'.
     
     This is from the Good Laboratory Practice regulations for Non-Clinical 
     Laboratory studies. My interpretation is that it is definitely 
     applicable to these types of studies, but you can probably draw a 
     corollary to other quality records as well. There should be 
     traceability to the original document, and a justifcation as to the 
     reason behind the modification.
     
     Yvette Lloyd
     Bio-Rad Laboratories

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