A paper printout or static record may satisfy retention requirements if it is a complete
copy of the original record (see §§ 211.68(b), 211.188, 211.194, and 212.60). For
example, pH meters and balances may create a paper printout or static image during data
acquisition as the original record. In this case, the paper printout or static image created
during acquisition, or a true copy, should be retained (§ 211.180).
However, electronic records from certain types of laboratory instruments are dynamic
records, and a printout or a static record does not preserve the dynamic format which is
part of the complete original record. For example, the spectral file created by FT-IR
(Fourier transform infrared spectroscopy) can be reprocessed, but a static record or
printout is fixed, which would not satisfy CGMP requirements to retain original records
or true copies (§ 211.180(d)). Also, if the full spectrum is not displayed, contaminants
may be excluded.
Control strategies must ensure that original laboratory records, including paper and
electronic records, are subject to second-person review (§ 211.194(a)(8)) to make certain
that all test results are appropriately reported.
For PET drugs, see the guidance for industry PET Drugs — Current Good Manufacturing
Practice (CGMP) for discussion of equipment and laboratory controls, including
regulatory requirements for records.