The archiving of records and materials generated during the course of a study is an important aspect of compliance with the Organization for Economic Co-operation and Development (OECD) Principles of Good Laboratory Practice (GLP). The maintenance of the raw data associated with a specific study and the specimens generated from that study are the only means that can be used to reconstruct the study, enabling the information produced in the final report to be verified and the compliance with GLP of a specific study to be confirmed. NIMR-Amani Research Centre has archive facility suitably designed and constructed to accommodate the archived records and materials with safes and lockable cabinets that provide suitable security. The archive facility is physically secured to prevent unauthorized access to the retained records and materials. The building and its room(s) that house the archive is constructed to withstand the elements of local weather. The risk of fire and explosion is minimized by provision of smoke detector systems and firefighting tools.
Archive Conditions
Storage conditions is designed to preserve and not adversely affect the quality and integrity of
retained documents (records) and materials. Back-up electrical power is installed to facilitate temperature and humidity monitoring by using air conditions and data loggers. Regular environmental condition maintained, tested, verified and records thereof retained, as required by the Principles of Good Laboratory Practices (GLP).
Security
NIMR-Amani archive facility is both physically and operationally secured to prevent un-authorized access and changes to or loss of retained records and materials. Test facility management ensured security by implementing appropriate measures that described in the test facility’s SOPs. The archivist is responsible for the management, operations and procedures for archiving in accordance with established Standard Operating Procedures (SOPs) and the Principles of GLP.
Access to the Archive
With normal archive operations, access to the NIMR-Amani Archive facility is controlled by and restricted to the archivist. When needs arises, visitors should be accompanied by the archivist, the procedures for access to archive storage facility is documented. The record of such visits is be retained. The Archivist ensure that the orderly storage and retrieval of records and materials is facilitated by a system of indexing and ensure that movement of records and materials in and out of the archives is properly controlled and documented.