Software concerns

M 31] [P 28] The flow patterns simulated by the ConventorWare and FLUENT 5 software concerning the flow in the cross-shaped micro mixer with two static mixing elements the same hence the predictability of the ConventorWare software was demonstrated [71]. 

ChemSketch is a professional software package that is available free of charge from Advanced Chemistry Development Inc. (ACD). Besides the editor, it has several modules (ACD/Dictionary, ACD/Tautomers), extensions, and add-ins concerning the calculation of physicochemical properties, input of spectra and chromatograms, naming of molecules, and a viewer. 

The hardware and software used to implement LIMS systems must be vahdated. Computers and networks need to be examined for potential impact of component failure on LIMS data. Security concerns regarding control of access to LIMS information must be addressed. Software, operating systems, and database management systems used in the implementation of LIMS systems must be vahdated to protect against data cormption and loss. Mechanisms for fault-tolerant operation and LIMS data backup and restoration should be documented and tested. One approach to vahdation of LIMS hardware and software is to choose vendors whose products are precertified however, the ultimate responsibihty for vahdation remains with the user. Vahdating the LIMS system s operation involves a substantial amount of work, and an adequate vahdation infrastmcture is a prerequisite for the constmction of a dependable and flexible LIMS system. 

Although the traditional point of reference for safety interlock systems is a hard-wired implementation, a programmed implementation is an alternative. The potential for latent defects in software implementation is a definite concern. Another concern is that solid-state components are not guaranteed to fail to the safe state. The former is addressed by extensive testing the latter is addressed by manufacturer-supplied and/or user-supplied diagnostics that are routinely executed by the processor within the safety interlock system. Although issues must be addressed in programmable implementations, the hard-wired implementations are not perfect either. 

Equipment technology and processing software for FTIR are very robust and provide a high degree of reliability. Concerns arise for only the most demanding applications. For quantitative work on an isolated feature in the spectrum, the rule of thumb is that the spectrometer resolution be one-tenth the width of the band. FTIR instruments routinely meet that requirement for solids. 

The requirement for procedures does not stipulate that they need to address all 30 requirements of this section of the standard. Procedures are required only for the control, calibration, and maintenance of these devices. The requirements in clause 4.11(a), for instance, requiring you to determine the measurements to be made and the accuracy required, are not requirements concerning the control, calibration, and maintenance of these devices. They are requirements concerning measurement. The procedure requirement only addresses the devices used for measurement and therefore does not apply to software other than software used for measurement. 

The programs are described at length in the NBS publication NBS-IR 87-3669, System of Hardware and Software Developed for Size Exclusion Chromatography by B. Dickens and F.L. McCrackln, National Bureau of Standards, 1987, and available from NTIS under order number 88153697. Host of that report is concerned with interactive operation of the programs. 

For instance, of great interest are through or continuous execution schemes available for solving the diffusion equation with discontinuous diffusion coefficients by means of the same formulae (software). No selection of points or lines of discontinuities of the coefficients applies here. This means that the scheme remains unchanged in a neighborhood of discontinuities and the computations at all grid nodes can be carried out by the same formulae without concern of discontinuity or continuity of the diffusion coefficient. 

Some questions could arise concerning process control and especially concerning the problem of deviation detection. Solutions can be found by using software able to monitor and supervise the process in order to guarantee production quahty and safety of the plant and operators [38]. 

LIMS as rented service— The application service provision provider (ASP) is a means of obtaining access to software applications without the need to acquire expensive licenses and hardware or employ high-cost support resources [7]. The application is hosted on a third-party site with system maintenance, backup, and recovery provided by a third party. Products and services can be rented for a contract period on a fixed cost per user/per month basis. The advantages of obtaining LIMS in this fashion include reduced cost in initial investment and reduced requirement of resources for maintaining the LIMS. The continued security and integrity of the data transferred over the Internet is a major concern for this type of LIMS. 

A recent review has described the numerous commercial concerns that are involved in systems biology by providing either software or services [24]. Large, curated interaction databases combined with powerful analytical... 

Because of the complexity of computer hardware and software and because of the intricacy of a risk assessment, the FDA has to all intents and purposes adopted an indirect regulatory posture. Regulated companies are informally urged to conduct independent audits of Part 11 compliance, utilizing in-house or consultant expertise. The agency can then review the details of the audit report and the credentials for experience, expertise, and independence of the auditor. Follow-up investigation of speciflc points can then be laser-focused on specific areas of concern. 

Johnson [17] identifies several topics related to liability, and she offers an important distinction as well. Among the topics related to liability and computer use in general are legal liability, the duty of honesty, the nature of contracts, misrepresentation, express and implied warranties, and negligence [17]. The relevant distinction concerns the nature of software as either a product or a service. Many of these topics hold little interest for the ethicist investigating computer ethics. For instance, legal liability is less important to philosophy than to jurisprudence. 

Distillation is a well-known process and scale-up methods have been well established. Many computer programs for the simulation of continuous distillation columns that are operated at steady state are available. In fine chemicals manufacture, this concerns separations of products in the production of bulk fine chemicals and for solvent recovery/purification. In the past decade, software for modelling of distillation columns operated at non-steady state, including batch distillation, has been developed. In the fine chemicals business, usually batch distillation is applied. 

---