If a GLP inspector requests information retained in an archive, can a test facility respond by retrieving electronic records from a company’s global electronic archiving system (physically located in another country)?

The response would be satisfactory as long as all required records can be retrieved from the archive. All electronic records should be verifiable on screen in human readable format and retained (OECD Guidance Document 17, paragraph 79).

The GLP Principles for archiving must be applied consistently to electronic and non-electronic data. It is therefore important that electronic data is stored with the same levels of access control, indexing and expedient “retrieval” as non-electronic data (OECD Guidance Document 17, paragraph 110).

Electronic data should be accessible and readable, and its integrity maintained, during the archiving period (OECD Guidance Document 17, paragraph.112).