Establishment and Control of Archives that Operate in Compliance with the Principles of GLP

This document is intended for use by test facilities that are required to operate in compliance with the Principles of GLP, for organisations that supply support, e.g. contract archives, contract quality assurance units or IT services and for sponsors, GLP compliance monitoring authorities and receiving authorities. Organisations should ensure that they evaluate applicable regulatory requirements against their business needs. Certain aspects of archive construction and operation may have implications for compliance with building regulations or legislation regarding public health and safety. Guidance on these aspects is outside the scope of this document. Test facilities and other organisations, engaged in archiving GLP records and material, might benefit from the use of recognised archiving management standards including those concerning metadata.