Archived data

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. 

Along with the capability for the operator to evaluate and trend, information can be communicated to a host computer. Additionally, archived data may be sent by modem to a remote location for use in planning, reporting, or expert evaluation by support personnel. 

Data Lockout Data Retention Data Archiving Data Sharing... 

Figure 2 shows that the path through the Data Handling Menu is quite restricted, in that some functions cannot be performed without first performing others. This is done because the chromatograph analyzes a group of specimens in one continuous operation (batch mode). Each set of data must be associated with pertinent archival data. 

Field, H.I., Fenyo, D., Beavis, R.C. (2002). RADARS, a bioinformatics solution that automates proteome mass spectral analysis, optimises protein identification, and archives data in a relational database. Proteomics 2, 36 17. 

H. I. Field, D. Fenyo, and R. C. Beavis. RADARS, a Bioinformatics Solution that Automates Proteome Mass Spectral Analysis, Optimises Protein Identification, and Archives Data in a Relational Database. Proteomics, 2, no. 1 (2002) 36-47. 

There are three data bases present in our MS/MS information management system, one for immediate experimental data and two for archival data. The experimenter s data base has been described elsewhere (1). One archival data base manages the MS/MS spectra, while the other manages the structures and substructures. The two archival data bases are logically linked together so that all information concerning a particular molecule or substructure is associated with its spectra. 

Profiling radiometers measure and display the peak power and total density ion of a UV curing system and also profile the temperature and irradiance as a function of time. The information is transferred into a computer. They are capable of comparing characteristics of multiple lamps, comparing UV systems over time, or comparing different systems to each other. They track and store archival data. An example of profiling radiometers is in Figure 9.6. 

It must be possible to reproduce the archived data in human-readable form throughout the retention period. Where applicable, the method of data transfer to any other system must also be formally documented and controlled. 

Every day, data systems are declared obsolete and no longer supported by their supplier, computer operating systems change and become obsolete, and hard drive and tape storage systems break down. It quickly becomes obvious to research laboratories how transient and fragile their archived data files really are. It is critically important to have access to file translation from these proprietary formats into a standard format running on modern computer systems. 

In addition to the retention of operating data in electronic format, the following list shows the supporting documentation that should be archived along with the data. The integrity of archived data is assured when the systems on which the data was produced have been validated, and the documentation relating to these systems has been assembled, as part of the validation file. 

Studies by Moscardo, Morrison et al. (1996) and Meikle (2003) provide some initial evidence consistent with the model outlined in Figure 4.8. Using archival data based on the Pleasure Travel Markets Survey, Moscardo and colleagues analysed the responses of 1503 outbound Australian travellers to a detailed interview on international travel behaviour. Three groups of travellers who emphasised different sets of travel motives... 

SAS Transport File Format. We are able to archive data sets in SAS XPORT transport format, also called version 5 SAS transport format. This is an open, published file format developed by SAS Institute. For additional information, see the SAS Institute s Standards for Electronic Submissions and SAS XPORT transport format Web site. 

Exercise 6.7 Working with archive data, it is often necessary to draw conclusions from incomplete graphic material. Fig. 6.29 summarizes chemical data of six samples collected from a spring over 5 years. The figure is contained in a report and no units are given (mg/1 or meq/1). Try to retrieve as much hydrological information as possible. 

Exercise 10.2 Archive data reveal that a well in the United States contained 1 TU in 1975. What was the effective age of the water ... 

However, adopting a new color system for suppliers and customers may mean discarding years of archived data (and perceptions) from their old system (and thinking). Three-dimensional Lab values would be useless, unless there were a way to convert those old numbers into a newer CMC tolerance. 

Analogous to today s paper-based environment, companies must be able to make requested data available within a reasonable period (typically a few hours for on-line data, and between 24 to 48 h for archived data). This is achieved by displaying the data on screen or by printing it out. As a rule, databases are usually more able to meet the individual requirements of inspectors than is currently the case with paper-based filing systems. However, because the systems used can only be operated in accordance with their specifications, it cannot be assumed that they will be able to answer every conceivable query. For each individual case, it must, therefore, always be clarified... 

Arguing with regnlatory anthorities that computerized systems caimot be rescued in terms of electronic record/signatnre compliance or that there was no point in archiving data from a nonval-idated system is not a defensible position. As a bare minimum, interim measures will be expected to have been taken nntil a final solution is implemented. Appendix 15C outlines the use of procedural and technical controls applicable to both pharmaceutical and healthcare companies and their snppliers. The application of interim measures is discussed further in Chapter 14. 

Quality Control personnel must know everything about the system, the validation, training records, etc. For example An individual may be asked about data that reside on a system and then asked to retrieve the archived data in question. This is to ensure that the individual knows what he or she is talking about. 

Backed up data stays in the iive system Archived data deieted from iive svstem... 

As discussed in Chapter 15, 21 CFR Part 11 has made archival problematic, especially in the world of preclinical and clinical data management where retention requirements may amount to decades. This means that it is virtually impossible to avoid archiving data, if only because it is impractical to keep obsolete hardware and applications running ad infinitum. 

Finally, firms intending to migrate data must remember to include already-archived data in their migration plans. It is possible that complications may arise with this archived data. For example, data archived from earlier software releases of the database might be readable through the current version, but it could be that minor differences in metadata could render this older data unreadable after migration if these differences are not specifically addressed in the migration process. 

Data management (e.g., in-house or devolved, data deletion from active directories, data restoration from archives, archived data expiry, and destruction)... 

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