FDA's 21 CFR 58.190 regarding commercial archives: What does it allow?

• A. Prohibits contracting with commercial archives
• B. Allows contracting with commercial archives to provide a repository for all material to be retained
• C. Requires all data to be stored in-house
• D. Prohibits outsourcing data management

Answer: (B)

The key idea here is that GLP allows outsourcing the storage of study records. The regulation recognizes that a sponsor can contract with a commercial archive to serve as the repository for all materials that must be retained. This means a third-party archive can securely store, organize, and preserve records for the required retention period, while keeping them accessible for inspections or data requests. The sponsor still has responsibility for choosing a reputable archive, ensuring the archive maintains data integrity and a proper chain of custody, and guaranteeing access to authorized personnel when needed. In practice, this provides a flexible option to manage long-term record retention without mandating in-house storage.