Part 11 requirements are not intended to apply to electronic systems that are merely
incidental to creating paper records that are subsequently maintained in traditional paper272
based systems. In such cases, the electronic systems would function essentially the same
way that manual typewriters or pens would function, and any signatures would be
traditional handwritten signatures. Storage and retrieval of records would be of the
traditional file cabinet variety. More importantly, the overall reliability and
trustworthiness of the records and FDA’s ability to access the records would primarily
derive from generally accepted procedures and controls for paper records. Therefore,
when sponsors or other regulated entities use electronic systems to generate paper
printouts of electronic records and those paper records meet all the requirements of the
applicable regulations, and persons rely on the paper records to perform regulated
activities, FDA generally would not consider sponsors or other regulated entities to be
using electronic records in place of paper records (see § 11.1(b)). In these instances, part
11 regulations would not apply to the electronic systems used to generate paper records.
However, if simple screenshots or paper printouts are used to produce a report and that
report fails to capture important metadata (e.g., the data originator and the audit trail of
the data) that are recorded in the electronic system, such paper records would be regarded
as incomplete unless the accompanying metadata are included. FDA would require
access to the electronic system used to produce those data to review the complete record
(see 21 CFR 312.58, 312.68, 812.140, and 812.145).