File manager system

File manager systems—Maintain files and handle data input to and output from the files. Database management systems (DBMS) contain integrated sets of files related by their use and provide uniform software interfaces for accessing data. The essential relationships between records in the files may be of several types, including sequential, associative, or hierarchical. 

The physical property system is supported by a data file on both conventional compounds and on typical coal analyses and data. The data bank contains correlation constants for over 400 conventional compounds and extensive data for thirteen characteristic coals. A Data File Management system permits a user to modify the data files, to create his own private data files, and... 

Figure 26 provides a different view of the ConceptDesigner"s structure. It shows that every project generates a series of distinct process flowsheets, all of which are handled by a file management system, which is organized in a hierarchical tree to reflect the evolution of the design and the various alternative designs. It also depicts the various sources of data... 

We are very accustomed to using forms and reports, often prepared in a standard fashion for a particular application. Record-based models are computer implementations of these spreadsheet-like forms. Two types can be identified. The first of these, common in the early days of file processing systems (FPSs) or file management systems (FMSs), is the individual record model. This is little more than an electronic file drawer in which records are stored. It is useful for a great many applications. More sophisticated, however, is the relational database data model, in which mathematical relations are used to electronically cut and paste reports from a variety of files. Relational database systems have been developed to a considerable degree of sophistication, and many commercial products are available. Oracle and Informix are two leading providers. 

There are several database types used for different purposes. On one hand simple models like a hierarchic or network model, which are used for simple data structures like a file management system of common computer... 

In distributed systems, each participating site must be equipped with a desktop or a laptop computer loaded with the distributed data collection system software to collect and enter data locally. In addition, each site is provided with necessary storage devices such as tapes, zip diskettes, and CDs and peripheral devices such as printers. Collected data are transferred periodically to the central location as files saved on storage devices, via phone modems, by FTP, or through wireless communications, where they are managed by a centralized data management system. 

Laboratory data may consist of many different collections of tests, such as ECG laboratory tests, microbiologic laboratory tests, and other therapeutic-indication-specific clinical lab tests. However, laboratory data traditionally consist of results from urinalysis, hematology, and blood chemistry tests. Traditional laboratory data can come from what are called local laboratories, which are labs at the clinical site, or from central laboratories where the clinical sites send their samples for analysis. Often when the laboratory data come from a central laboratory, there is no physical CRF page for the data and they are loaded into the clinical data management system directly from an electronic file. Local laboratory data may be represented with a CRF page such as this ... 

The randomization of a patient in a given therapy is the cornerstone of a randomized clinical trial. You may find these data in more than one place. They are often found within some form of Interactive Voice Response System (IVRS), but they may also be found in an electronic file containing the treatment assignments or on the CRF itself. If randomization data are found on the CRF, they usually consist only of the date of randomization for treatment-blinded trials. IVRS data are often found outside the confines of the clinical data management system and usually consist of the following three types of data tables. 

Once the raw clinical data have been imported into SAS, the next step is to transform those raw data into more useful analysis-ready data. Raw data here mean data that have been imported without manipulation into SAS from another data source. That data source is likely to be a clinical data management system, but it could also be external laboratory data, IVRS data, data found in Microsoft Office files, or CDISC model data serving as the raw data. These raw data as they exist are often not ready for analysis. There may be additional variables that need to be defined, and the data may not be structured in a way that is required for a particular SAS analysis procedure. So once the raw data have been brought into SAS, they usually require some kind of transformation into analysis-ready files, which this chapter will discuss. 

Both classes of Operating Module usually need one or more input time series and produce one or more output time series (eg. outflow of water and constituents). From experience, the designers of HSPF knew that much of the effort in using continuous simulation models is associated with time series manipulations. Thus, a sophisticated Time Series Management System was included. It centers around the Time Series Store (TSS) (Figure 10), which is a disk-based file on which any input or output time series can be stored indefinitely. 

Beyond simple data storage and instrument control, modern data systems provide extensive data analysis capabilities, including fitted baselines, peak start and stop tic marks, named components, retention times, timed events and baseline subtraction. Further, they provide advanced capabilities, such as multiple calibration techniques, user-customizable information and reports and collation of multiple reports. If a Laboratory Information Management System (LIMS) is available, the chromatographic data system should be able to directly transfer data files and reports to the LIMS without user intervention. The chapter by McDowall provides a terse but thorough description of the... 

If the quality manual is written and used in electronic form, first of all the same requirements have to be met. There must be a system for managing the access rights on the files, a system to ensure that no unauthorized documents is placed on the system, that all withdrawn documents are stored for later information and that all documents are securely backed up. 

The planning of the quality management system is carried out in order to meet the requirements given in 4.1 as well as the quality objectives, and file integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. 

Every analytical laboratory, governmental, private, or university, has a standard set of procedures that provide both general and specific information to laboratory members. These fall into certain categories, including the laboratory s standard operating procedures (SOPs), quality assurance/quality control manuals (QA/QC manuals), procedural manuals, analytical method files, and laboratory information management systems... 

These cross-referenced numbers are the key to the electronic relational data bases. Key field data and sample storage data are entered into location and sample number files in QUIZ Software (4). Laboratory analysis information is contained in files generated using Perkin-Elmer Laboratory Information Management System (LIMS) and Chromatographic Laboratory Analysis System (CLAS) software. 

The laboratory should verify and document the proper functioning of the software immediately after any new data acquisition or management systems have been installed. The baseline verification consists of manual calculations to confirm the correctness of all computer calculations. Ongoing verification takes place during laboratory data review process whenever a reviewer replicates one of the results generated by the computer or a manual calculation from a bench sheet. All information used in the calculations (raw data, calibration data, laboratory QC checks, and blank results) is kept on file for the reconstruction of the final result at a later date, should it become necessary. Bench sheets that document sample preparation are also kept on file for the same purpose. 

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