Who determines the adequacy of archiving procedures?

• A. Testing facility management
• B. QA auditors
• C. Sponsors
• D. FDA inspectors

Answer: (A)

Archiving procedures are part of how a testing facility runs its day-to-day operations and quality systems. The people who manage and run the laboratory are responsible for creating, implementing, and regularly reviewing these procedures—deciding what gets archived, for how long, how it’s stored, who can access it, and how it will be retrieved. That ongoing ownership and authority to set and adjust the standards lies with facility management, ensuring the records meet regulatory requirements and internal policy.

QA auditors, sponsors, and FDA inspectors play important roles in oversight and verification. QA auditors check that the procedures exist, are followed, and meet applicable standards; sponsors define requirements and expectations; FDA inspectors assess compliance during inspections. But the actual determination of whether archiving procedures are adequate rests with the facility’s management, who establish and maintain them.