Integrated communications defined

Conventional filtration theory has been challenged a two-phase theory has been appHed to filtration and used to explain the deviations from paraboHc behavior in the initial stages of the filtration process (10). This new theory incorporates the medium as an integral part of the process and shows that the interaction of the cake particles with the medium controls filterabiHty. It defines a cake-septum permeabiHty which then appears in the slope of the conventional plots instead of the cake resistance. This theory, which merely represents a new way of interpreting test data rather than a new method of siting or scaling filters, is not yet accepted by the engineering community. 

Relays have inputs from several current transformers (CTs) and the zone of protection is bounded by these CTs. While the CTs provide the ability to detect a fault inside the zone, circuit breakers (CBs) provide the ability to isolate the fault by disconnecting all of the power equipment within the zone. Thus, a zone bonndai y is usually defined by a CT and a CB. When the CT is part of the CB it becomes a natural zone boundaiy. When the CT is not an integral part of the CB, special attention must be paid to the fault detection and fault interruption logic. The CT still defines the zone of protection, but communication channels must be used to implement the tripping function. Figure 1 shows the zones of protection in a typical system. 

Essential medicines are defined by the WHO (2004) as "those that satisfy the priority health care needs of the population. .. selected with due regard to public health relevance, evidence on efficacy and safety and comparative cost-effectiveness." The important point is that, for this authoritative international public health body, "comparative cost-effectiveness" evaluation (or relative value to a community) is an integral part of the basic conception of an "essential" medicine. 

Black box testing is also known as functional testing, benchmark testing and, in the pharmaceutical community, as an operational qualification (OQ). It tests the functionality and correctness of a computer system by running the integrated software, and is performed for one of two reasons defect detection, and/or reliability estimation. It should cover all functions of the application software that the end-user will use, and will verily the completeness and accuracy of system requirements used to define the test cases. 

Narrowly focused, the tenets of 21 CFR 11 are indisputable that firms must establish and maintain the integrity of their electronic information. What has been lost is the clear indication of which electronic information the requirements apply to. In my opinion, data generated outside a computerized system, that are manipulated by that system and are ultimately available in hard copy should not be subject to this ruling. Validation of the computerized system should be more than sufficient to establish that the final documentation accurately reflects the input information. In that instance, the computerized system is little more than a tool whose functionality can be readily established, yet firms are endeavoring to assure 21 CFR 11 compliance for numerous systems in which the computer is little more than an adjunct to the cGMP activity and corresponding hard copy. Batch record preparation, SOP and test method archives, and many process equipment control systems are examples of systems in which requirements for 21 CFR 11 compliance appear excessive. A system that processes or communicates data or records and subsequently retains and stores hard copies should not be subject to the 21 CFR 11 requirements. Far too many systems are being unnecessarily held to the very restrictive portions of 21 CFR 11. Electronic record retention as defined in 21 CFR 11 has its place, but not necessarily in every computerized system used within the industry. 

Data that successfully meet the challenges posed in these questions can be said to exhibit certain distinctive characteristics—hallmarks, as we have called them in this document—that are indicative of data quality appropriateness, accuracy, integrity and transparency. Table 1 provides a brief overview of the hallmarks, their definitions and some general examples. As the summary table indicates, these four hallmarks of data quality are closely related and may in some cases overlap. In particular, the need for transparency in documentation and communication cuts across each of the other hallmarks. In the paragraphs that follow, we define each hallmark in greater detail and illustrate how implementation of the principles they embody can improve the quality of exposure assessments and the decisions that follow from them. 

Several excellent works on collaboration have been published (Blount, 1998 Doherty 8c Baird, 1983 Seaburn, Lorenz, Gunn, Ga-winski, 8c Mauksch, 1996). Doherty (1995) developed a model that defines five levels of collaboration. The levels range from minimal collaboration, in which professionals work in different sites and rarely communicate about a case, to close collaboration in a fully integrated system, in which professionals from different disciplines practice in the same site and hold team meetings regularly to discuss collaboration issues. For most physicians and therapists, level 5 is more of a dream than a reality. Because of the structure of health care today, most professionals probably practice at levels 1 or 2. 

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