For some national GLP compliance monitoring programmes, it is acceptable to archive electronic data in a primary database with the use of appropriate access rights (i.e. read only permission for the study director / the study staff/QA and full rights for the archivist etc.). For other national programmes, data can be physically transferred to another location or to a storage medium (also with the corresponding access right modifications) for archiving. Are both acceptable?

Archived electronic data should be protected physically and logically in order to meet the requirements of a GLP archive. Electronic data should be accessible and readable, and its integrity maintained, during the archiving period (OECD Document No 17, paragraph 112).

Electronic records may be moved from the production part of a computerised system to a discrete, secure archive area on the same computer system (e.g. physically separated file record systems), or explicitly marked as archived (e.g. logically separated database record systems). Records should be locked such that they can no longer be altered or deleted without detection. Records archived in this way must be under the control of a designated archivist and be subject to equivalent controls to those applied to other record types (OECD GLP Document 15 Section 8.3).