Computers, automated assessment

Bound the design space by assessing total computer automation vs. total human manual control solutions... 

Section I of this book includes chapters on the principles and practice of PLC. After this introductory Chapter 1, Chapter 2 provides information on efforts undertaken to date in order to establish the theoretical foundations of PLC. With growing availability and popularity of modem computer-aided densitometers, separation results can be obtained in digital form as a series of concentration profiles that can be relatively easily assessed and processed. From these, relevant conclusions can be drawn in exactly the same manner as in automated column chromatographic techniques. Efforts undertaken to build a theoretical foundation of PLC largely consist of adaptation of known strategies (with their validity confirmed in preparative column liquid chromatography) to the working conditions of PLC systems. 

A natural extension of analytical automation is some means of data processing all the results that are generated. This usually takes the form of a central computer which accepts information from different analysers for presentation in a useful manner. The identification of a sample and the tests performed are typed in using a keyboard and the computer collates all the data on each sample. As well as collecting information, computing and statistically assessing results, an important facility of the computer lies in its ability to store information for future recall via a visual display unit. 

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. 

Ohio River Division perform a variety of computer assisted tasks in assessing water quality and providing input to water management decisions. These include developing and running sophisticated water quality models evaluating water quality data and operating an automated water quality laboratory. 

CHAZOP Computer HAZard and OPerability study to assess the threats and their control between Automation Systems, their users and operational environments, and the manufacturing process. CHAZOP studies for IT systems concenti ate on the threats and then-controls affecting data integrity. [Defined for this book.]... 

The Principles of Nonvisual, Algorithmic Similarity Analysis Automated Similarity Assessment by Computer... 

To enable automated spectral quality assessment, several computational tools that can be used to detect unassigned high-quality spectra and mark them for subsequent reanalysis have been developed in recent years. A first approach, presented by Bern et al., predicts spectral quality based on a... 

The Ocular Irritection assay has been used for over 20 years to assess the ocular irritancy of industrial chemicals, pharmaceuticals, textile, petrochemicals, surfactants and cosmetic products. It represents a refinement of the former Eytex method that takes into account the recommendations made during earlier multilaboratory trials [1], The system underwent substantial revisions including the development of a single protocol, clear procedures for surfactants testing, and a well-defined applicability domain. It is presented as a kit comprising instrumentation and computer software that have been integrated to provide an automated in vitro test. Furthermore, because of its biochemical nature, Ocular Irritection has a long shelf-life (years) and can be readily available across the world. 

Expert Systems as "Automated Documents." Sometimes a user needs to make a decision based upon the consideration of categorical or qualitative information, rather than calculations involving numerical parameters. Expert Systems comprise several types of computer programs that address this type of information. Risk Assistant will contain a variety of small expert systems that assist users in different aspects of the risk assessment process. 

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