What considerations govern data archiving in GLP?

• A. Secure, labeled, accessible storage, defined retention periods, and procedures for retrieval and destruction
• B. Archiving is optional and unstructured
• C. Archiving only applies to paper records
• D. No retrieval or destruction procedures

Answer: (A)

In GLP, data archiving is about preserving study records so they remain verifiable and retrievable over time. Records and data from GLP studies must be kept in a secure, labeled repository that protects integrity and allows access only to authorized personnel. It’s essential to define how long records must be retained, so retention periods are clear and regulatory or sponsor requirements are met. There must also be documented procedures for retrieving archived data when needed and for destroying records once the retention period ends, following approved methods. This applies to both paper and electronic records and systems, ensuring traceability, accountability, and auditability throughout the data lifecycle. If any of these elements were missing—for example, no defined retention, or no procedures for retrieval or destruction—the archive wouldn’t meet GLP standards.