Computerized analytical

Computerized Analytical Approach. The logic flow-chart for the analysis is shown in Figure 1. An assumption is first made about the nature of the polymer mixture. For example, in a two-component mixture different combinations of statistical... 

In this work, examples are shown of the use of the computerized analytical approach in multicomponent polymer systems. The approach works well for both fractionated and whole polymers. The methodology can (1) permit differentiation to be made as to Whether the given sample conprises one conponent or a mixture of several components (2) allow the NMR spectrum of a polymer mixture to be analyzed in an unbiased fashion (3) give information on mole fractions and reaction probabilities that can be significant variables in understanding catalyst structures or polymerization mechanisms. 

The computerized systems, both hardware and software, that form part of the GLP study should comply with the requirements of the principles of GLP. This relates to the development, validation, operation and maintenance of the system. Validation means that tests have been carried out to demonstrate that the system is fit for its intended purpose. Like any other validation, this will be the use of objective evidence to confirm that the pre-set requirements for the system have been met. There will be a number of different types of computer system, ranging from personal computers and programmable analytical instruments to a laboratory information management system (LIMS). The extent of validation depends on the impact the system has on product quality, safety and record integrity. A risk-based approach can be used to assess the extent of validation required, focusing effort on critical areas. A computerized analytical system in a QC laboratory requires full validation (equipment qualification) with clear boundaries set on its range of operation because this has a high... 

Huber, L, Validation of Computerized Analytical Systems, Interpharm Press, Buffalo Grove, IL, 2000. 

Is there a computerized, analytical results tracking and graphing system [process management software or statistical process control (SPC)] in place, as well as manual checks ... 

Chapter 19 Case Study 1 Computerized Analytical Laboratory Studies.449... 

Computerized analytical equipment FIGURE 19.1 Computerized Laboratory. 

Figure 19.1 shows an example of a complex computer system that includes computerized analytical instruments for the collection and evaluation of data, servers for data review and centralized archiving, and a laboratory management system. 

Table 19.1 lists in chronological order the steps that a user of computerized analytical equipment can follow for the entire validation process. 

The type and degree of validation of a computerized analytical system depends on its complexity. For example, the functions of a simple, computer-controlled system, with little or no flexibility regarding data input or evaluation, can be verified by execnting holistic tests and by comparing the test results with anticipated results. On the other hand, a more complicated compnterized system with on-line databases and extensive flexible data evalnation requires complex validation. 

Huber, L. (2002), Validation of Computerized Analytical and Networked Systems, Interpharm, Englewood, CO. 

Wyn, S. Regulatory requirements for computerized systems in pharmaceutical manufacture. Softw. Eng. J. 1996, 11. Huber, L. Validation of Computerized Analytical Systems Interpharm Press USA, 1995. 

Huber L (1995) Validation of computerized analytical instruments, Inter-pharm, Buffalo Grove, IL, USA, ISBN 0-935184-75-9 Hewlett-Packard Part Number 5959-3879... 

This article gives practical validation steps for two types of computer systems integrated computerized analytical systems and a network for file printing and archiving. 

Integrated computerized analytical systems, for example chromatographic systems with computer software for instrument control, data acquisition and data evaluation. Data are printed and electronically stored. Sometimes these computer systems employ spreadsheet programs or user-contributed Macros for customized data evaluation. 

Based on the lecture notes of A. Bmtsche on the subject of Calibration and Qualification of Analytical Equipment in Pharmaceutical Quality Control , the four concepts of equipment qualification in the field of analysis are listed here and elucidated in the form of headings [148]. The subject is discussed in more detail by L. Huber in the book Validation of Computerized Analytical Systems [149],... 

What constitutes an electronic analytical laboratory -Figure IAl-1 shows the major components of a paperles.H laboratory. First, a computerized analytical instrument is required to acquire, manipulate, and process the data. Ific instrumcnl may he connected to its own data system, as are many chromatography instruments, or directly lo an electronic laboratory notebook. The notebook ofien provides input lo a aI)oratory information management system (LI MS), as discussed in section 4H-2, and to a laboratory data-archiving system. In some cases, information from the data system or notebook flows directly into archival storage. Several of these components are discussed In this case study. 

Modem computerized analytical instruments have quantitative analysis programs that allow the analyst to specify the calibration standard concentrations, select the curve-fitting mode, and calculate the results of the samples from the calibration curve equation. Many of these programs will remn outher standards and samples automatically, flag suspect data, compute precision and recovery of spikes, track reference standards for quahty control, and perform many other functions that used to be done manually by the analyst. 

Huber, L. Validation of computerized analytical systems. Part 3 Installation and operational qualification. LC GC 1996,14 (9), 806-812. 

Modeling Computerized analytical representation of a structure or process. 

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