Operating systems, lack

After the system has been released for operation, system maintenance activities take over. The importance of such activities is characterized by recent FDA remarks related to the lack of change control management by regulated organizations. The FDA s analysis of 3140 medical device recalls conducted between 1992 and 1998 reveals that 242 of them (7.7%) are attributable to software failures. Of those software related recalls, 192 (or 79%) were caused by software defects introduced when changes were made to the software, after its initial production and distribution. 

In spite of the enormous use of vacuum processes, detailed knowledge of vacuum technology is often lacking. Design calculations are often attempted with incomplete or inadequately-interpreted data and, even with well-designed systems, operators may lack the confidence to use them optimally and often struggle to solve relatively small problems when they arise. In both cases, at some cost and delay, there is complete reliance on vacuum equipment manufacturers appraisal. 

Special dedicated hardness testers or multifunctional systems are used to measure the degree of force (in kilograms, pounds, or arbitrary units) required to break a tablet. Devices to test tablet hardness include the Monsanto tester, the Strong-Cobb tester, the Pfizer tester, the Erweka tester, and the Schleuniger tester. A force of about 4 kg is considered the minimum requirement for a satisfactory tablet. Multifunctional automated equipment can determine tablet weight, hardness, thickness, and diameter. Unfortunately, these testers do not produce uniform results for the same tablet due to operator variation, lack of calibration, spring fatigue, and manufacturer variation. 

Na+ and Mg++ stimulate the enzyme phosphorylation reaction generating phosphory-Iated enzyme intermediate E-P (first step) which is dephosphorylated in the presence of K+ (second step). The net result is the transport of 3Na+ out of the cell and 2K+ ions into the cell per ATP molecule hydrolyzed. ATP binds and is hydrolyzed on the cytoplasmic side of the membrane. A simplified mechanism for the overall process is shown below where Ei and E2 represent two conformations of the protein which have high affinities for Na+ and K+ respectively. Complete details of how the ATPase/pump system operates are lacking, but probe experiments using orthovanadate(V) have provided some insight into the mechanism. 

The computer system lacked documentation defining database, operating system, location of files, and security access to database. [FDA Warning Letter, 2001]... 

It could be difficult to retrospectively vahdate a computer system if there were changes and revisions that were not documented and the cumulative effects of many revisions had not been assessed. Lack of sufficient system documentation would make it impossible to perform meaningful retrospective vahdation. FDA concludes that the XXX and YYY systems lack adequate validation and therefore are unacceptable for use in the production of drag products. Please indicate whether you can perform a retrospective validation of XXX and YYY systems or rely in the interim on manual operations, which use source documentation until the new validated computer systems are functional. [FDA Warning letter, 2001]... 

The FDA will consider the lack of computer validation as a significant inspection finding and log it as a 483 noncompliance citation. The MHRA may take a more lenient view depending on the criticality of the system on GxP operations. The lack of a detailed written description of an individual computer system (kept up to date with controls over changes), its functions, security and interactions (EU GMP Annex 11.4) a lack of evidence for the quality assurance of the software-developed process (EU GMP Annex 11.5), coupled with a lack of adequate validation evidence to support the use of GxP-related computer systems may very well be either a critical or major deficiency. Ranking will depend on the inspector s risk assessment. 

Although the plant was scheduled for completion in 1938, the first trial runs could not be made until 1941. It was apparent from these that the air-conditioning installation was inadequate—the frost which deposited was much fluffier than had been anticipated and its thermal conductivity was too low. The whole system was delicate to operate and lacked flexibility. Attempts to improve its operation were not satisfactory and it was eventually decided to abandon the single-step, direct expansion ammonia system. Because of war and postwar conditions, nothing more could be undertaken until 1949-50. 

Table 1.4 lists the priority R D needs that were identified for burners, boilers, and furnaces. Essentially all of these needs require some amount of testing. These needs were generated from the following end-use requirements increased system efficiency reduced NOx, CO, CO2, and particulate emissions increased fuel flexibility more robust and flexible process control and operations better safety, reliability, and maintenance lower capital and operational costs faster, low-cost technology development and enhanced system integration. Coupled with these needs are some barriers to improvement financial risk, inability to accurately predict the performance of new systems, lack of industry standards, and the wide gap that often exists between the research done at a small scale that needs to be applied to industrial-scale systems. Testing is often required to address some of these barriers. 

The lack of content demonstrated in Figure 7.1 served to emphasize how neglected meta-data is, and how even modern operating systems may not handle it at all Simple fields such as document title, author names, creation dates, and... 

Finding 15. A wide range of operating systems exist in the chemical agent stockpile incineration facilities, and this variability could pose problems for effective long-term continued operability. At the least, costs and maintenance are complicated by this diversity and apparent lack of integrated planning. 

QTS software validation specifications lack details such as the hardware platforms the software should run on (model number, CPU [central processing unit], RAM [random access memory], hard drive size, free hard drive space, etc.), the software operating system, software database specifications (such as number of records accommodated, number of fields, whether those fields are character or numeric or date or alphabetical fields), the number of concurrent users allowed, the development platform used to write the application, network information, report contents and other information needed to perform testing properly. 

Commercial workloads have been shown to have dramatically different behavior compared to scientific and engineering workloads (Barroso et al., 1998 Keeton et al., 1998). Due to the fraction of time spent in the memory system and lack of instruction-level paraUehsm, there is a relatively small gain from improving integer processor performance (also, there is no floating-point computation). Commercial applications also make frequent use of operating system services and I/O, making the performance of system software more important. 

The Polish Standard PN lEC/ISO-TR 13335-1 (Polish Standard 1999) defines the term IT security as all activities related to confidentiality, integrity, reh-ability, availability, etc of a computer system. The term safety of a computer system is defined as the lack of negative impacts on surrounding environment computer operating system. 

The organization responsible for installation of the rectifier system, whether it be the operating company itself or an outside design contractor, probably will lack knowledge of the overall power supply situation. Therefore, most electric utility authorities will propose standard empirical methods for estimating the effects of a proposed new installation. In the final analysis, however, measurements must be made on the operating system. Harmonic filters can be installed to compensate for the problem, but in the real world it may later be found that these must be adjusted to cater for unforeseen conditions. 

When the demand for vapor is higher, apparatus designed for this purpose becomes necessary. This section discusses design and operation of such vaporizers. Not all plants operate vaporizers, but these units still account for a large fraction of the releases of chlorine that producers and users report. Vaporization is relatively a more frequent operation among users who do not produce chlorine. In many cases, vaporization becomes a batch operation, which lacking a steady state can be more hazardous. Many incidents have resulted from overloading a scrubber system with liquid [75]. The relative lack of experience and sophistication on the part of some operators may help to account for... 

Identification of operational indicators Lack of explicit consideration of the issues within an operational safety case, as compared to a developmental safety case A non-adaptive governance system that is unable to support the transition from novel introduction to mature practice... 

The use of PEG-functionalized pyridine ligands has also been reported for the preparation of water soluble, second-generation, Grubbs bis-pyridine catalysts. Emrick and coworkers [104, 105] at UMass Amherst have two reports describing catalysts 119-124. In the later report, a catalyst system incorporating a hydrophilic phosphorylcholine (PC)-functionalized pyridine ligand, 125, was also described. This series of catalysts was studied for a catalyst s ability to perform the ROMP of water-soluble monomers. The PEG-based systems lacked activity under neutral conditions, but performed well at low pH. In contrast, catalyst 125 could operate in both neutral and acidic media. 

Regrettably, at present, ejqrressions such as operator error, lack of common sense, carelessness, act of God, bad luck, stupidity, etc., are part of the safety management mantra. Their use and inference brings an acceptance that the error or cause has been identified and explained. As a consequence, we stop looking for real causes. However, the model above assirmes all work takes place in a system and consequentty the focus on human error is diminished in favour of accidents resulting out of systems failure. 

High dependency on automation in secured external network connections and lack of qualified cyber security business in industrial controls Trends for moving toward COTS operating systems and designs to integrate BPCS, SIS, and business networking and access through standard open system protocols... 

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