When generated to satisfy a CGMP requirement, all data become a CGMP record. You
must document, or save, the data at the time of performance to create a record in
compliance with CGMP requirements, including, but not limited to, §§ 211.100(b) and
211.160(a). FDA expects processes to be designed so that quality data required to be
created and maintained cannot be modified. For example, chromatograms should be sent
to long-term storage (archiving or a permanent record) upon run completion instead of at
the end of a day’s runs.
It is not acceptable to record data on pieces of paper that will be discarded after the data
are transcribed to a permanent laboratory notebook (see §§ 211.100(b), 211.160(a), and
211.180(d)). Similarly, it is not acceptable to store data electronically in temporary
memory, in a manner that allows for manipulation, before creating a permanent record.
Electronic data that are automatically saved into temporary memory do not meet CGMP
documentation or retention requirements.
You may employ a combination of technical and procedural controls to meet CGMP
documentation practices for electronic systems. For example, a computer system, such as
a Laboratory Information Management System (LIMS) or an Electronic Batch Record
(EBR) system, can be designed to automatically save after each separate entry. This
would be similar to recording each entry contemporaneously on a paper batch record to
satisfy CGMP requirements. The computer system could be combined with a procedure
requiring data be entered immediately when generated.
