Personal data, definition

For definition of sensitive personal data see Schedule 2. The extra safeguards relating to the First Principle are contained in Schedule 3. 

The first data protection principle contains the requirement that personal data shall be processed fairiy and lawfully. Given the inclusion of obtaining in the amplified definition of processing, this is essentially the same requirement as that contained in the 1984 Act. The cases of Innovations, Linguaphone and CCN Credit Systems discussed in Section 12.6.1 above are thus likely to remain of relevance. The principle then continues... 

The Working Party and other groups consider not only the application of the relevant law but also a variety of non-legal solutions which might assist in the resolution of some of the difficulties. Problems with the divergence of definition of personal data may be resolved if identification of specific individuals is never possible from data traces, i.e. the promotion of anonymity on the Internet. An earlier recommendation of the Working... 

The following sections discuss each of these steps in detail and present a process that can be used to help insure successful problem definition. The two steps in the Solving the Problem phase of the project are not discussed in this chapter. Experimentation is dependent on the method that is used to probe the system and relies on the expertise of the person(s) collecting the data. Analysis of Experimental Results is the application of the chemomctric tools and is the topic of Chapters 3-5. 

Existing definitions of various detection and quantitation limits can be confusing to a non-laboratory person. Despite misleading similarities of these definitions, there is a logic and order to the basic concepts that they express. Various detection limits that we commonly refer to in our daily work (the IDLs, MDLs, and PQLs) are discussed in this chapter in the increasing order of magnitude of their numeric values. Some of these detection limits are determined experimentally and depend on the matrix and the method of preparation and analysis, while others may be arbitrary values selected by the laboratory or the data user. The relationship between these three levels of detection is approximately 1 5 10. 

The Internet is a classic example of an open system in the definition of 21 CFR Part 11 Open system means an enviromnent in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system. As illustrated in Figure 39.2. ISPs have access to data, which means the persons who are responsible for the content cannot control access to any data transferred through the Internet. 

The statistical links between weight and cardiovascular disease are flat-out scary. One of the most definitive studies began in 1967. Data were collected until 2002. During those years, subjects were classified as normal weight, overweight, or obese. The risk of being hospitalized for heart problems quadrupled in men and women after age sixty-five in the obese group. Obese individuals were also more likely to die from heart attacks and strokes than thinner persons were. 

Clear definition of responsibilities and individual accountability are important. An individual may have the responsibility to develop and colleet metrics information but may not be accountable for the results themselves. For example, the objeetive for process safety improvement is to lower the number of ineidents, yet the individual responsible for collecting process safety incidents data may not be the person to be held responsible for an increase in incidents. The individual responsible for collecting data would, however, be responsible for the aeeuracy of the data. 

Requirements for controls are based on definition of closed or open system. Under these definitions there isno direct correlation between, for example, using a publicphone line and an open system. Compliance with closed versus open standards is determined by how access rights to the data or documents are established and controlled by the owner(s) of this information. A system is defined as closed if access to the system containing the records or data is under the control of person(s) responsible for the content of the records or data in the system. A system is defined as open if access to the system is not under the control of the person(s) responsible for the content of the records therein. For example, dial-in retrieval over a public phone is closed where the records being accessed are under the control of the persons responsible for their content, whereas storage of records on a third party system is open because access to the records themselves is under the control of the third party. Sections 11.10 and 11.30 of the Final Rule list, respectively, the control measures required for establishing a closed or open system. 

Collection Mechanism The trusty index card will work for performing inspections, but this requires the individual to remember the inspection criteria or refer to an inspection list and make notes about observations. A clipboard with a predefined set of questions (that can be answered yes or no ) for each machine is a definite improvement on the index card method. Be sure to leave a space for comments. Both the index card and the clipboard approach require manual entry of the data once they are collected. A more modern approach is to set up the inspection in an industrial-quality personal digital assistant. For each machine, the inspector can answer yes or no, and as required, write short comments. These comments could be selected from a drop-down menu to minimize inconsistency. The data can then be uploaded to a host computer for storage. This speeds the process, ensures that the data will be captured, and reduces transposition errors. 

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