Yes. FDA permits the interchangeable use of electronic records and paper records for the
archiving and protection of records provided that recordkeeping and retention
requirements are met (see 21 CFR 56.115, 312.57, 312.62, and 812.140). If the sponsor
or other regulated entity intends to use an electronic copy in place of the paper source
data (i.e., intends to destroy the paper source data), then part 11 regulations would apply
to the electronic system used to create the copy (see §§ 11.10 and 11.30)). A process
should be in place to certify that the electronic copy is an accurate representation of the
original paper document. The copy of the original record should be verified as having all
of the same attributes and information as the original record and certified as indicated by
a dated signature. Sponsors and other regulated entities should have written procedures
to ensure consistency in the certification process.
In addition, some electronic copies vary in terms of their ability to be modified. For
electronic copies in which the records are modifiable, it would be important to have audit
trails in place to ensure the trustworthiness and reliability of the electronic copy. Also, as
noted earlier, 21 CFR 11.10 and 11.30 require physical, logical, and procedural controls
designed to ensure the authenticity and integrity of electronic records.
