For a small facility with limited resources, which option would be most GLP-compliant and practical for archiving paper raw data?

• A. Purchase a used, fireproof filing cabinet, replace the locks, and create an SOP using a paper index to log in/out contents.
• B. Store all data in a password-protected personal computer.
• C. Keep only digital copies and shred originals.
• D. Hire an external cloud service with no on-site archive.

Answer: (A)

Raw data retention under GLP means keeping the original paper records safe, legible, and traceable for the required retention period. A practical approach for a small facility with limited funds is to use a fireproof filing cabinet, replace the locks, and implement an SOP with a paper in/out log. The fireproof cabinet provides protection against fire and physical damage, helping preserve the integrity of the originals. Replacing the locks creates controlled access so only authorized personnel can reach the data, reducing the risk of tampering or loss. The SOP with a log or index documents what is stored, where it is, and when it was accessed, establishing an auditable chain of custody and accountability. This setup keeps data on-site, which makes retrieval straightforward for audits and regulatory checks and is cost-effective, a critical factor for small facilities with limited resources. It also preserves the originals rather than relying solely on digital copies, which may fail or become inaccessible over time.

Compared with relying on a password-protected PC, that method risks data loss due to hardware failure or software obsolescence and does not establish a robust physical archive or chain-of-custody. Storing only digital copies and shredding originals fails to meet GLP expectations for raw data retention and accessibility. An external cloud service with no on-site archive introduces vendor risk, ongoing costs, and reliance on an external system for data retrieval, which may complicate audits or disaster recovery.