The accountability of lab records stems from the Barr decision and the falsification of laboratory
data. Q7A is an international document; it is not just a U.S. document. It provides good, sound
guidance on documentation practices, but it does not specify sequential numbered sheets or the
level of documentation that has come to be used in the U.S. for lab records since the Barr
decision. Q7A allows flexibility in meeting documentation practices.
