Copies of Records — §11.10(b)

Copies of Electronic Records. The system shall be capable of generating accurate and complete copies of electronic records in both human-readable and electronic form suitable for inspection, review, and copying by the FDA, in accordance with §11.10(b). Human-readable copies shall include all relevant metadata, including the identity of the person who created, modified, or deleted the record, the date and time of such action, and any electronic signatures associated with the record. Electronic copies shall be provided in a format that preserves the content, meaning, and context of the original record, and that allows the FDA to inspect, review, and copy the records using commonly available software. The system shall support the export of electronic records in formats such as PDF, XML, CSV, or other formats agreed upon with the reviewing authority. Procedures shall be established to define the process for generating copies of records upon request, including the identification of authorized personnel, the timeframe for producing copies, and the verification that exported copies are accurate and complete. The ability to generate accurate copies shall be verified during system validation and re-verified after any system change that could affect record generation or export capabilities.