Archive Facilities

A special case has been addressed in the OECD Advisory Document on in vitro studies (OECD No. 14, 2004). In this area of rapid progress, especially with the development of genetically engineered test systems, there may be instances where test systems are of limited availability, or have even been 

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A physical component of IT life cycle management is storage media management. Tapes, disks, and other electronic media degrade over time. Optimally, they are refreshed every 10 years. Ideally, this is part of the SOPs for the data centers and archive facilities. 

Archive facilities should be provided for the secure storage and retrieval of raw data, final reports etc. 

Archive facilities for easy retrieval of study plans, ravir data, final reports, samples of test items and specimen... 

General archival needs are controlled access, safe and appropriate storage, and retrievability. The types of items to be archived include paper, field samples, test chemical samples, and electronic records. In general the following types of archive facilities are needed sample freezers and cold rooms, test chemical freezers, file cabinets and/or boxes for paper, and magnetic media for electronic records storage. 

GLP Storage and retrieval with archive facilities OECD 10.2... 

Are external organizations managing backup and archive facilities subject to appropriate controls including ... 

The final report and any amendments, all raw data, documentation, protocols and any amendments, and specimens (with the exception of specimens subject to degradation) generated as a result of a nonclinical laboratory study shall be retained in an archive. The archive facility needs to be set up for orderly storage and expedient retrieval. Conditions of storage shall minimize deterioration of the documents or specimens. The archives do not necessarily have to be an in-house facility the laboratory may contract with commercial archives to store materials in a GLP fashion. 

Reconstruction of a study is only possible, if all documents, records and materials from this study can be made available in an unadulterated and unspoiled condition for scrutiny and for tracking the course of events. Archive facilities have to satisfy such conditions as to provide an environment where the completeness and the integrity of study-related materials can be continually ensured. 

It stands to reason, that all the records, data, specimens, samples and documents which are produced and compiled in the context of GLP studies, and of GLP test facilities, including documents and records of the Quality Assurance have to be stored somewhere for possible future examination. In order to allow for a later reconstruction of studies from this documentation, this storage cannot consist of simply creating a pile of all study-related and test facility-related material in a dusty attic or a dank cellar. The first consideration in archiving is that all this material should be stored under the proper conditions suitable to protect the contents of the archive from untimely deterioration . This technical aspect of the archive facilities proper has already been dealt with in section 5.4 (see page 180) and need not be taken up again... 

First of all the physical location of the various study materials may be different, as has been described in the section on archive facilities (see page 180), and this has to be reflected in the archive s indexing and retrieval system. It has therefore to be ascertained that on looking up the identification tag of a specific study one would be led to the location of all the various documents and materials related to this study, and which have been identified as materials to be archived in the study plan and the final report. 

There is one exception to this rule, and this is the archives of the Quality Assurance. Quality Assurance is also required not only to retain the documents pertaining to its own activities, but also to retain copies of approved study plans and of test facility SOPs in use. Although it would not be impossible, and certainly not forbidden, to archive these records and documents in the general archive facilities and under the care of the person responsible for the general archives. Quality Assurance may nevertheless choose to store these documents in its own, special facility, to which only Quality Assurance personnel could be given access. For this case, the GLP Principles do not spell out a special requirement for singling out a specific individual. 

The first of these measures is the already mentioned limited access to the archives. Only those individuals authorised by management should have access to all archive locations. This translates into the requirement that only a limited number of keys should be available for the archive facilities, all of which should be securely kept, allowing only the authorised persons to use them. It has to be recognised, however, that for cases of an emergency, like fire or a leaking water pipe, threatening the archive and its contents, a reserve key should be placed with the technical department in the test facility. 

J.D. Harmon, Integrated Pest Management in Museum, Library and Archival Facilities, Harmon Preservation Pest Management, Indianapolis, IN, 1993, 92. 

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