For any facility performing studies intended for FDA submission, the equipment used to generate raw data must have

• A. A Written SOP describing its maintenance and calibration
• B. A Vendor-maintained calibration log only
• C. An Annual user manual review
• D. A Fixed installation date

Answer: (A)

For data integrity and regulatory auditability, a facility must have a documented, facility-specific procedure that outlines how equipment used to generate raw data is maintained and calibrated. A Written SOP provides the who, what, when, and how: who is responsible, exactly what maintenance and calibration tasks are required, how often they occur, the methods and acceptance criteria used, and how results and actions are recorded and stored. This creates a traceable, repeatable process that regulators can review to confirm that data come from properly maintained and calibrated equipment. Relying solely on a vendor-maintained calibration log leaves gaps in internal control and accessibility during audits. An annual manual review does not ensure ongoing maintenance or calibration, and a fixed installation date ignores ongoing drift and service needs. So, the Written SOP describing maintenance and calibration best supports compliance and data integrity.