It depends on what a company’s policies and
procedures expect. If there are sufficient controls in the
system and people are sufficiently trained, so that when
sample reprocessing occurs, it’s occurring under the proper
conditions with the proper controls and procedures in place,
then the audit trail comment may be enough. However, if the
procedure doesn’t address the reprocessing of samples, or if
it’s considered anomalous or unusual, then it may be important
to have an explicit documented approval process.
