Archiving, spreadsheet

The spreadsheet does not require special training. It is designed as a fill out only spreadsheet. The completed spreadsheet will be stored in folder E. ... After review, second-person verification, and sign-off the electronic version will be archived in database ABC. 

The archiving section will include information about purpose, record classification, and archive location(s). It has to be defined which data generated during the validation of the spreadsheet will be classified as raw data or results (GXP records) the electronic data or a printout. The raw data and all data and documents that have been generated during validation must be archived. Figure 18.10 is an example. 

From preprint servers 319 Ward, D. W. Nelson, K. A. Finite Difference Time Domain (FDTD) Simulations of Electromagnetic Wave Propagation Using a Spreadsheet. 2004,arXiv physics/0402096.arXiv.org e-Print archive, http //arxiv.org/abs/physics/0402096 (accessed Oct 13,2004). 

The next most cited group of observations concerned backup and archive. Systematic backups are required to meet defined schedules. Backups and archives must be maintained for the duration of the record retention requirements and for records readily retrievable. The Warning Letters making these observations referred to CDS, Spreadsheets, electronic drawings and to the implied use of Computer Aided Drawing (CAD) application, complaint files, and Device History Records. 

Security as a topic is referred to the same number of times as backup and archive. Security issues raised stress the need to limit access to computer systems to protect records, and in one instance deficient password controls are mentioned. Computer systems referred to include CDS, CAD, Record Keeping Systems, and Spreadsheets. 

After the validation and release, the spreadsheets need to be brought to a restricted folder. The retired spreadsheets need to be archived so that the user cannot erroneously take a retired one. 

Some researchers, of medical scientists or biostatisticians, have maintained that the same record could be used for all purposes it is merely a matter of what the researcher is allowed to access. There seems to be a general feeling that an ARC should be a distinct archive outside the security firewall, with the identified records held inside. Moreover there are subtleties in statistics that allow certain statistical overviews to nail down detailed data. For example, if a spreadsheet, contains multidimensional data with only averages in the rows and columns, it should not be possible for anyone to work back from the marginal summaries to deduce the interior of the spreadsheet. But in fact a mathematical algorithm is already known to medicine that allows medical images to be constructed—tomography. 

---