Documentation archiving/storage

I think. .. I arrange my words carefully. As far as I understand her, she doesn t think restoring the Chantry is the important thing, that it s the documents that matter. And she s—she s worried they won t be safe at the Chantry. Though, of course, we wouldn t dream of keeping them there unless we could have proper archival storage. ... 

This subterranean salt deposit contains relatively pure metal-containing compounds. After the deposits are mined, the resulting caverns are very dry and thus make excellent archival storage sites for moisture-sensitive equipment or documents. 

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... 

Evaluation of side effects on other systems Data migration/archiving Storage of system documentation Cancellation of servicing contracts/licenses Physical disposal... 

The specifications for the DXS local station were established by agreement between the local representative of the consortium and the Beneficiary. In principle it is made up of 3 PCs. These will be bought locally, by the Consortium s local representative, under Tacis procurement procedure, in progress at date. Additional documentation archiving and editing equipment (PCs, scanners, printers so) will also be provided to the plant in order to improve the documents storage and management conditions. 

The principal use of CD-ROM and WORM disks is essentially substitution of data storage on paper or microfiche. Conservative estimates number the worldwide use for data storage by paper at 91%, microfiche at 4%, and in electronic media at 5%, of which 4% are magnetic and 1% optical media (18). CD-ROM is being used as an electronic counterpart to print media the WORM disk presents itself more and more as a substitute for paper to store archivable, forgery-proof documents. 

Document storage, libraries, and archive, who controls, location, loan arrangements Document retention and obsolescence... 

In the author s experience, field residue trials can be conducted in Latin America under complete compliance with all ERA guidelines and recommendations. More time does need to be spent in planning and preparation to ensure that the personnel involved in the testing have been trained in GLP and that this training, as well as the compliance of equipment, storage and archival sites, standard operating procedures (SOPs), and quality assurance (QA) audits, are properly documented. 

With electronic notebook studies, there will also be paper data to audit. This will include facility data (e.g., weather data, equipment maintenance records, storage temperature logs, personnel records, etc.) and study specific documents, such as faxes, e-mails, paper notes, etc. When paper data have been transcribed into the electronic notebook, they should be checked by QA to ensure accuracy. Any data that have been transcribed for whatever reason must be identified as such with the original raw data attached to them. QA should ensure that all paper data have adequate identification (e.g., study and trial numbers), that they are recorded per GLP, including dated signatures, and that all of the pertinent paper data or exact copies are sent to the Study Director for archiving. 

The responsibility of the QA unit should not be limited to in-process inspections and data and report audits. To be in full compliance with GLP, the QA unit should review all procedures for storing and archiving electronic as well as paper raw data. This review should include ensuring that back up and archiving procedures were performed as specified in the SOPs, that archiving was documented properly, and that long-term storage procedures were followed. 

All raw data, documentation, records, protocols, specimens, final reports, and correspondence relating to data interpretation must be retained and archived according to the Storage and Retrieval of Records and Data paragraphs (EPA 160.190 and FDA 58.190) found in this subpart, and these records must be available for expedient retrieval. The archived records shall be carefully protected and indexed. 

In most cases these materials will be stored in the archives of the testing facility, and the report will so indicate. In the case of contract safety testing, however, a sponsor will sometimes ask that raw data, documentation, and specimens be sent to the sponsor for storage in the sponsor s archives. In other cases a laboratory may store some or part of the archival material at an off-site location. In either case the final report should reference the actual storage site(s). 

Any laboratory that conducts noncUnical laboratory studies must provide dedicated space for the storage of raw data, documentation, protocols, specimens, and interim and final reports from completed studies. The laboratory must have an orderly system for storing such material, and that system must provide an expedient method for retrieving of archived materials (e.g., on the request of an FDA inspector). 

The records and documents required to be maintained by the QAU are also subject to the record retention requirements of 58.195(b). Spokesmen for the FDA have stated on occasion that these QA records should be stored in the archives described in 58.190(b). This is an option that can be considered by the QAU, but there is no stipulated requirement in the GLP regulations for such storage. In fact, it could be argued that the requirement of 58.35(a) for the QA function to be independent of nonclinical laboratory study personnel militates against storage of QA records in the archives. 

The GLP standards state that all raw data, documentation, records, protocols, specimens, and final reports generated as a result of a study shall be retained. Specimens do not need to be retained after QA verification. Storage conditions must allow for expedient retrieval with an indexing system. Access to the archived records must be limited to authorized personnel. 

There shall be archives for orderly storage and expedient retrieval of all raw data, documentation... Conditions of storage shall minimize deterioration of the documents... in accordance with the requirements for the time period of their retention. 

The batch record is the only documentation a firm has that can demonstrate that the product was manufactured according to specifications. During regulatory audits, the batch record is a primary document for review, and must be easily and quickly accessible. Most firms have two different modes of storage—recently executed batch record storage and long-term archival. It is recommended that a schedule be established to require that the most recent batch records executed (e.g., the last 6 or 12 months) are readily accessible and any batch records older than this be transferred to a long-term archival location. 

---