FDA Electronic Signature Certification

FDA Electronic Signature Certification Letter. Prior to or at the time of first use of electronic signatures to satisfy a signature requirement established by a predicate rule, the organization shall submit a certification to the FDA, in accordance with §11.100(c), stating that the electronic signatures used within the organization's systems are intended to be the legally binding equivalent of traditional handwritten signatures. The certification letter shall be: (a) submitted in paper form on organizational letterhead; (b) signed with a traditional handwritten signature by an authorized representative of the organization (typically a senior quality or regulatory official); (c) addressed to the Director of the FDA Office of Regional Operations (HFC-100), 12420 Parklawn Drive, Rockville, MD 20857 (or such other address as the FDA may subsequently designate); (d) clearly identifying the organization's name, address, and FDA Establishment Identifier (FEI) number; (e) identifying the specific systems or categories of systems for which electronic signatures will be used; and (f) retained as a controlled record by the organization, along with proof of delivery (e.g., certified mail receipt), for the life of the electronic record systems to which it applies. The certification shall be updated and resubmitted if the organization undergoes a change in legal name, ownership, or if new systems employing electronic signatures are deployed for new predicate rule applications. The Quality Unit shall maintain a log of all certifications submitted to the FDA.