Computer systems applications

The second section covers Treliminary List of Computer Applications and Systems of Potential Use Under SARA Title III" and contains a list of computer systems applicable to local planning. The list is not anticipated to be fully comprehensive of the environmental computer systems market nor is it intended to act as an endorsement for any of the listed systems. The list is only intended to serve an initial reference source. Vendor names, addresses, and phone numbers have been provided it is essential that the vendor be contacted to obtain current cost capability, availability, and limitation information for any system of interest. 

Over the years regulatory authorities have identified three major concerns regarding computer system application. 

Examples of the U.S. regulations applicable to computer system application in a GMP environment are shown in Table 1. The FDA also publishes compliance policy guides [7] related to pharmaceutical drag products and views the guidance provided on related products (e.g., medical devices [8]) to be current good manufacturing practice that should be considered for comparative GMP applications. 

To maintain control of the computer system throughout its conception, implementation, and operational use in a GMP environment, it is required that the computer system application must be validated in a way that will establish auditable documented evidence that the computer system does what it is expected to do. As applicable, this needs to be carried out in conjunction with plant equipment to provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. The methodology to achieve this is based on a recognized life-cycle mode. 

The validation life-cycle phases align closely with the project stages for new computer system applications. With this in mind, it is recognized that a significant proportion of the documentation required for validation may be generated by a well-controlled and -documented project. 

For new or existing computer system applications, adherence to a life-cycle approach for validation will provide ... 

A fundamental objective of a computer system applied to automate a pharmaceutical GMP operation is to ensure the quality attributes of the drug product are upheld throughout the manufacturing process. It is therefore important that quality-critical parameters are determined and approved early in the validation life cycle. The exercise should be undertaken to a written procedure with base information from the master product/production record file examined and quality-critical parameter values and limits documented and approved for the process and its operation. In addition, the process and instrument diagrams (P IDs) should be reviewed to confirm the measurement and control components that have a direct impact on the quality-critical parameters and data. This exercise should be carried out by an assessment team made up of user representatives with detailed knowledge of both the computer system application and process, and with responsibility for product quality, system operational use, maintenance, and project implementation. This exercise may be conducted as part of an initial hazard and operability study (HAZOP) and needs to confirm the quality-related critical parameters for use in (or referenced by) the computer control system URS. 

Support documentation Documentation that provides background information about the computer system application, but that is not essential to the execution of the IQ protocol or required to adequately document the system... 

The decommissioning procedure must address both operational and safety aspects of the computer system application and establish integrity and accuracy of system data until use of the system and/or process is terminated. For quality-related critical instrumentation, proof of calibration prior to disconnection is needed. 

An assurance that the physical hardware, software, and the regulated electronic records are maintained in a secure environment is critical to the validated status of a computer system, particularly if it is an enterprise level system. Security must be instituted at several levels. Procedural controls must govern the physical access to computer systems (physical security). The access to individual computer system platforms is controlled by network specific security procedures (network security). Finally, application level security and associated authority checks control access to the computer system applications (applications security). 

Assess interdependencies between critical computer systems/applications. 

Computers Applications for computers in plant engineering oigemizations are almost endless. As industry becomes more computerized, plant engineers must learn computer skills to compete. A few computer systems applicable to plant engineering are ... 

Courtois, P. J. (1977), Decomposability Queueing and Computer System Applications, Academic Press, New York. 

The first results of computer-based assessment system application show that the benefits are obvious for repaired (without heat treatment) welds and complex defect configurations defect with height local increasing, group of defects, case analysis of defects interference and possible joining. 

Singh, U.C., Kollman, P.A. A combined ab initio quantum mechanical and molecular mechanical method for carrying out simulations on complex molecular systems Applications to the CH3CI 4- Cl exchange reaction and gas phase protonation of polyethers. J. Comput. Chem. 7 (1986) 718-730. 

Time Systems, McGraw-HiU, New York, 1985 Hawryszldewycs, Database Analysis and Design, Science Research Associates Inc., Chicago, 1984 Kham-hata, Microprocessois/Microcomputers Architecture, Software, and Systems, 2d ed.. Whey, New York, 1987 Liptak, Instrument Engineers Handbook, Chilton Book Company, Philadelphia, 1995 Melhchamp (ed.), Real-Time Computing with Applications to Data Acquisition and Control, Van Nostrand Reinhold, New York, 1983. 

The handbook additionally provides an extensive overview and comparison of commercially available computer systems and software for chemical emergency planning. This section provides technical guidance for hazard analysis and identification implementing regulatory requirements and descriptions of computer applications and systems applicable under SARA Title III. 

The applicability of these findings for actual operational tasks was evaluated by considering the incidence of data entry errors recorded by the on-line plant computer system over the 24-hour shift cycles. It was judged that the data entry task, which involved evaluating the set point changes needed for... 

For catastrophic demand-related pump failures, the variability is explained by the following factors listed in their order of importance system application, pump driver, operating mode, reactor type, pump type, and unidentified plant-specific influences. Quantitative failure rate adjustments are provided for the effects of these factors. In the case of catastrophic time-dependent pump failures, the failure rate variability is explained by three factors reactor type, pump driver, and unidentified plant-specific Influences. Point and confidence interval failure rate estimates are provided for each selected pump by considering the influential factors. Both types of estimates represent an improvement over the estimates computed exclusively from the data on each pump. The coded IPRDS data used in the analysis is provided in an appendix. A similar treatment applies to the valve data. 

Plastic ease of processing with low cost have given them a wide application in solving problems in electronic packaging. They range from inexpensive consumer devices to sophisticated expensive computer systems and cellular phones. 

Overall control is provided by the PDP-11/44, running DEC S RSX-llM operating system. RSX-llM is a multi-user multi-task operating system, and a number of other analytical instruments are interfaced to this computer system and are running concurrently. The automated Instron software is menu-driven because our experience has shown that menu-driven software is particularly effective for applications of this type. To perform either test the user accesses a main menu from which separate menus for instrument calibration, tensile tests, and flexure tests can be reached. The tensile and flexure menus have equivalent options the choices pertaining to automated testing are as follows ... 

---