The Archives

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 

As already mentioned, a very specific case might occur for in vitro test situations when not only samples and specimens from a study should have to be archived, but when an entire test system should have to be retained. 

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Historical DataBase Subsystem We have discussed the use of on-hne databases. An historical database is built similar to an on-line database. Unlike their on-line counterparts, the information stored in a historical database is not normally accessed directly by other subsystems for process control and monitoring. Periodic reports and longterm trends are generated based on the archived data. The reports are often used for long-term planning and system performance evaluations such as statistical process (quality) control. The trends may be used to detect process drifts or to compare process variations at different times. 

The historical data is sampled at user-specified intervals. A typical process plant contains a large number of data points, but it is not feasible to store data for all points at all times. The user determines if a data point should be included in the list of archive points. Most systems provide archive-point menu displays. The operators are able to add or delete data points to the archive point hsts. The samphng periods are normally some multiples of their base scan frequencies. However, some systems allow historical data samphng of arbitraiy intei vals. This is necessaiy when intermediate virtual data points that do not have the scan frequency attribute are involved. The archive point lists are continuously scanned bv the historical database software. On-line databases are polled for data. The times of data retrieval are recorded with the data ootained. To consei ve storage space, different data compression techniques are employed by various manufacturers. 

NCUACS (2000) Annual Report of the National Cataloguing Unit for the Archives of Contemporary Scientists, University of Bath, UK, p. 10. 

This requirement supplements that for records to be readily retrievable but in addition implies a further requirement for security of records. After addressing the filing and storage requirements, you need to ensure that the records are accessible to those who will need to use them. This applies not only to current records but to those in the archive and any insurance copies you may have stored away. A balance has to be attained... 

Records soon grow into a mass of paper and occupy valuable floor space. To overcome this problem you may choose to microfilm the records but keep them in the same location or archive them in some remote location. In both cases you need to control the process and the conditions of storage. With paper archives you will need to maintain records of what is where, and if the archive is under the control of another group inside or outside the organization, you will need adequate controls to prevent loss of identity and inadvertent destruction. 

The other major properties computed by a frequency job are the polarizability and hyperpolarizability tensors. Normally, the polarizability is printed at the end of the output, just before the archive entry ... 

In a normal Hartree-Fock job, the hyperpolarizability tensor is given only in the archive entry, in the section beginning HyperPolar=. This tensor is also in lower tetrahedral order, but expressed in the input (Z-matrix) orientation. (This is also true of the polarizability tensor within the archive entry.)... 

The title section consists of one or more lines of descriptive information about the job. It is included in the output and in the archive entry but is not otherwise used by Gaussian. This section is terminated by a blank line. 

NUMBER OF VOLUMES SUBMITTED Please enter the number of volumes, including and identifying electronic media, contained in the archival copy of this submission. 

If the test facility claims to be GLP-compliant but is located in a country where there is no authorised body responsible for GLP monitoring, i.e., a national GLP compliance program, the Study Director needs to be assured that the facility (including the archive, if used) does operate in compliance with GLP principles. This can be achieved by conducting a pre-study QA test site inspection or by a review of documentary evidence, e.g., notice of adverse findings and subsequent responses, or Establishment Inspection reports. The Study Director should ideally discuss the above with QA personnel and send copies of any documentary evidence used to the Quality Assurance Unit (QAU) for inclusion in the QA multi-site study file. 

The foiiowing data shouid be retained in the archives for the period specified by the appropriate reguiatory authorities ... 

Material retained in the archives should be indexed so as to facilitate orderly storage and retrieval. 

Only personnel authorized by management should have access to the archives. Movement of material in and out of the archives should be properly recorded. 

If a test facility or an archive contracting facility goes out of business and has no legal successor, the archive should be transferred to the archives of the sponsor of the regulatory study. 

The software life cycle activities extend until retirement of the software. However, in a manner of speaking, life cycle activities extend even beyond retirement since the data must be able to be reconstructed at any time during the life of the product, i.e., the archived record must always be accessible and readable even if the software is no longer commercially available or typically employed in the laboratory. Additional software validation includes implementation of the code and integration and performance testing. There also must be system security, change control procedures, audit trails, calibration, preventative maintenance, and quality assurance. 

The archiving of electronic data poses more specific challenges. GLP requires records retention and retrieval of archival records. Since software used for the creation of electronic records is upgraded at a rapid pace, the requirement of retrievable archived records can be difficult to comply with. Even when stored on electronic media, the records have to comply with the records retention period and be retrievable. The collection, storage, and retrieval of electronic records should address all GLP aspects, including environmental conditions to ensure the integrity of the media. 

Is there a SOP for archive requirements and retention policies (Is the archived material indexed, is there document control and is it secure )... 

Archived electronic data are to be treated no differently to archived paper data. An archivist should be assigned, access should be limited to authorized personnel, data should be archived at the completion of the study, and all material should be indexed to permit expedient retrieval. Depending on the medium used for storage, an area within the facility may be needed with specific environmental controls to maintain the integrity of electronic data. This should be specified in the data storage SOPs. Environmental conditions need to be monitored in the archives where electronic media are stored. 

Finally, some further documents have been developed by the separate inspectors groups (which report via the European Union s Pharmaceutical Committee), and these can be found in the What s New or the Archive section of the Enterprise DG web site. 

I know. But he ought to be retiring, not coping with tenants. He s not going to be able to go on with the Press for much longer either. And what matters will be safe at San Diego the archive, the proof prints, all the rest of it. And the history in the book. There s so much interest in the fine presses of the past. ... 

She s living in Highgate, cataloging the archive. She s got her own life, says Gareth. 

But San Diego are expecting the archive. I should be at home finishing the catalog now. ... 

Clymer, Reuben Swinburne. The book of Rosicruciae a condensed history of the Fraternitas Rosce Crucis or Rosy Cross, the men who made the order possible, and those who maintained the Fraternity throughout the centuries, together with the fundamental teachings of these men according to the actual records in the archives of the Fraternity. Philosophical Publ Co, 1946-1948. 3 vols... 

Geigy Co. Dr. Paul Muller, 1899-1965. Obituary and short biography in Novartis Archives, Basel. For his retirement research. I am indebted to the Archives of the Novartis International AG, Basel, Switzerland, for this document. 

The Patterson Papers in the Archives of the California Institute of Technology contain the Patterson Papers ( PP here) and Historical Files. I am indebted to the Archives for permission to quote from their holdings. 

Only one specimen is flagged as being mounted on the machine at any given time. Each data collection task passes the archival Information for the mounted specimen to the data file that it creates. 

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