Yes, electronic signatures with the appropriate controls can be used instead of handwritten signatures or initials in any CGMP required record. While § 211.186(a) specifies a “full signature, handwritten,” as explained in the Federal Register on September 29, 1978 (43 FR 45069), part of the intent of the full signature requirement is to be able to clearly identify the individual responsible for signing the record. An electronic signature with the appropriate controls to securely link the signature with the associated record fulfills this requirement. This comports with part 11, which establishes criteria for when electronic signatures are considered the legally binding equivalent of handwritten signatures. Firms using electronic signatures should document the controls used to ensure that they are able to identify the specific person who signed the records electronically.There is no requirement for a handwritten signature for the MPCR in the PET CGMP regulations (21 CFR part 212).
