Elements of a Test Facility such as IT services and archives can be an integral part of the Test Facility or be outsourced by written agreements. Test Facility management should have an overview of all suppliers relevant for IT services. Electronic archiving is a GLP relevant service (OECD Document No 17, paragraph 34, 109 – 118 and OECD Document No 15). It is the responsibility of Test Facility management to evaluate the service and to estimate risks to data integrity and data availability.
