See sections 4.2 and 7.2.2 within OECD GLP Document 15 “Establishment and Control of Archives that Operate in Compliance with the Principles of GLP” (2007).
GLP records and materials include both the study and the facility records. Facility records (support records, or related records and materials) would include non-study specific records such as equipment maintenance, staff training, organisational charts, SOPs, Master Schedules, Quality Assurance inspections, validation for computerised systems, environmental monitoring, and archiving processes (record transfers, specimens or electronic media disposals).
