Computerized system computer systems

When outside agencies are used to provide a computer service, there should be a formal agreement including a clear statement of the responsibilities of that outside agency [13]. When the release of batches for sale or supply is carried out using a computerized system, the system should allow only a qualified person (QP) to release the batches and it should clearly identify and record the person releasing the batches. This is possible by giving the QP an operational level in the computer system that allows it to release batches. No other person should have the same operational level authorization as the QP. 

General Properties of Computerized Physical Property System. Flow-sheeting calculations tend to have voracious appetites for physical property estimations. To model a distillation column one may request estimates for chemical potential (or fugacity) and for enthalpies 10,000 or more times. Depending on the complexity of the property methods used, these calculations could represent 80% or more of the computer time requited to do a simulation. The design of the physical property estimation system must therefore be done with extreme care. 

We need to transition from quasi-computerized methods, in which the different elements of the analytical process are treated as discrete, paper report tasks, to a comprehensive informatics approach, in which the entire data collection and analysis is considered as a single reusable, extensible, auditable, and reproducible system. Informatics can be defined as the science of storing, manipulating, analyzing, and visualizing information using computer systems. [3]... 

Computerized systems should be included in facility inspections of field sites and analytical laboratories. Items discussed previously, such as computer maintenance records and personnel training records, can be reviewed more thoroughly during the facility inspection. 

The character and the degree of automation in chemical control may have been covered in the above treatment of semi-automatic or completely automatic, and of discontinuous or continuous analysis, but something more should be said about the means by which automation proper has been performed in recent times. Whereas in the past automated analysis involved the use of merely, mechanical robots, to-day s automation is preferably based on computerization in a way which can best be explained with a few specific examples. Adjustment knobs have been increasingly replaced with push-buttons that activate an enclosed fully dedicated microcomputer or microprocessor in line with the measuring instrument the term microcomputer is applicable if, apart from the microprocessor as the central processing unit (CPU), it contains additional, albeit limited, memory (e.g., 4K), control logics and input and output lines, by means of which it can act as satellite of a larger computer system (e.g., in laboratory computerization) if not enclosed, the microcomputer is called on-line. 

The principle cost of creating an ES is not the hardware on which the system runs or the software that is used to create it, but the cost of employing a human expert to create the system. Not only are human experts expensive creatures, but they also may be understandably reluctant to spend time developing a computerized copy of themselves, knowing that, the more perfectly they manage to distil their expertise into a computer system, the greater the chance that they will make themselves redundant. 

Equipment must be suitable, maintained and, where appropriate, calibrated. Computer systems used to generate, store and retrieve data should be of appropriate design and capacity, validated and suitably located. If there are computerized systems used to control environmental factors, then these also require the same consideration. Issues relating to computerized systems are covered in Section 9.2.1.8. 

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... 

A computerized laboratory can utilize a software package called a laboratory information and management system (LIMS) to carry out or control all of these requirements provided that computerized instrumentation, computer terminals, printers and plotters, disk drives etc. are linked together in a local... 

Security systems are available featuring magnetic badges, personnel identification numbers, passphrases, or even digital or retinal scanners that unlock those specific areas to which the individual employee has been granted access. Since these systems are computer controlled, the access authorization for any individual can be conveniently and quickly adjusted as circumstances warrant. Logging of traffic in the various areas can be accomplished automatically. It should be understood that computerized systems are susceptible to intrusion and may therefore lack the positive control of a well organized and monitored system of secure keys or combinations. 

Chemical Hazards Response Information System/Hazard Assessment Computer System (CHRIS/HACS) Developed by the Coast Guard, HACS is a computerized model of the CHRIS manuals. It is used by federal on scene coordinators during a chemical spill or response. 

User requirement specifications (URS) for the computerized system are provided by the pharmaceutical firm to the computer systems vendor. The vendor generates functional and design specifications as a basis for designing and coding software for the computerized system. The system is then built, together with all the interfaces to the hardware, and tested by the vendor. After installation of the computerized system, IQ, OQ, and PQ are performed at the pharmaceutical facility to verify that the system is able to meet the URS and design and functional specifications. 

Computer validation establishes documented evidence to show that the computerized system will consistently function and meet its predetermined specification and quality attributes with a high degree of assurance. Some of the parameters tested in the validation process include the following ... 

Reinmann BC, Warren AD. User-oriented criteria for the selection of Dds software. Commun ACM 28 (2) 166-179, Feb. 1985. Report evaluates lab-safety trends. R and D 37.12 13, 1995. Romano CA. Privacy, confidentiality, and security of computerized systems The nursing responsibility. Computers Nurs 99-104, May/June 1987. 

Computer systems are used worldwide in the pharmaceutical industry and have direct bearing on product quality. The purpose of validation is to demonstrate that the intended product manufactured, packed, or distributed using a computerized controlled system will meet the safety, efficacy, and potency requirements per the individual monograph. 

To produce an adequate validation close cooperation between key personnel and those involved with the computer systems is essential. People in responsible positions should have the appropriate training for the management and use of systems within their field of responsibility which utilizes computers. This should include ensuring that appropriate expertise is available to provide advice on aspects of design, validation, installation, and operation of computerized systems [12]. 

The software—a program enabling computer to perform a specific task—is a critical component of a computerized system. Even a simple calculus sheet could be considered software, as it allows a computer to perform a specific task. The user of such software should take all reasonable steps to ensure that it has been produced in accordance with a system of quality assurance [13]. 

Adequate alternative arrangements should be available for systems which need to be operated in the event of a breakdown. The time required to bring the alternative arrangements into use should be related to the possible urgency of the need. If the system fails or breaks down, the procedures to be followed should be defined and validated. Any failures and corrective actions taken should be recorded [13]. Special cases of breakdowns are power breakdowns. It is required that some computer systems work for 24 h and should not be interrupted after starting data acquisition. Consequently, an extra uninterruptible power supply (UPS) is required to allow the operation of these computerized systems during power breakdowns. 

Computerized Physician Order Entry (CPOE) Studies have shown that CPOE is effective in reducing medication errors. It involves entering medication orders directly into a computer system rather than on paper or verbally. The Institute for Safe Medication Practices conducted a survey of... 

Networked systems with integrated databases are used extensively in the pharmaceutical industry. These are computerized systems, and as such, must be qualified and validated to demonstrate suitability of their intended use. While validation of stand-alone computer systems is well described [8] and understood, there is still uncertainty on how to qualify networks and networked systems. On the other hand, inspectors are looking more and more into such systems, and validation of... 

Questions have been raised about the feasibility of establishing evaluation norms that can be used across different populations and settings, or with similar tests used on different computer test systems. Certainly, situational factors influence performance on computerized performance tests. In addition, epidemiological factors, such as gender and age, have been demonstrated to influence performance on these tests. Due to mechanical and electronic differences across computer systems,... 

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