Records

Since documentation is a chief element of QA, thus most requirements mentioned above for chain of custody, personnel qualification, access log, validations, QC, certification of results, final report of results, data to support the results and unusual occurrences having an impact on the results require documentation with authentication by an authorized person. Becoming a record that must be retrievable, the documentation must be maintained at least for 2 years – in a secure location -after the results are reported. Record custodians, the individuals bearing the responsibility to maintain the records, must be designated in writing by the laboratory director. Since the record custodian’s position is formal, he may be asked to release official copies of records to court officials and authenticate that they are “true and accurate copies of originals maintained in the files.”

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