Audit scribing
During a quality audit, the scribe is a critical role responsible for documenting every word said, and question asked, while another person handles the document requests. This creates a play-by-play for the back room and a historical record to ensure response consistency and track what the investigator reviewed. The scribe should be an expert in the English language who is familiar with both quality systems and regulatory agency documentation. On February 2, 2026, the FDA's Quality Management System Regulation (QMSR) went into effect, replacing the old Quality System Regulation (QSR) and aligning U.S. requirements directly with international ISO 13485:2016 standards. Investigators now conduct inspections of overseas facilities to catch data integrity flaws, record falsification, and just-in-time cleanups. Some of these inspections are unannounced, which means that it is a good idea to be inspection-ready at all times.
