The use of a global archive should be included in the appropriate SOPs. Test Facility SOPs must define and describe the archive facilities and processes, including contracted archiving services or storage at a different physical location. Routine Quality Assurance inspections and audits should be conducted of the services provided.
In the event of the closure of a test facility or an archive contracting facility, any data transfer to an archive within another country should include informing both GLP monitoring authorities in order to ensure the coverage by the GLP compliance monitoring program if required by that country [OECD Guidance Document 15 Section 11].
