Control of records

Organizational (organization, management system, document control, control of records)... 

The control of data related to testing and calibration is covered in 5.4.7. The control of records Is covered in 4.13. 

Security services will be provided for applications to apply appropriate business rules for access control of records based on the identity, roles, and purposes (i.e., business functions), in addition to distributed security services for authentication, authorization, confidentiality, integrity and nonrepudiation, to protect the best interests of stakeholders. Later in this book we will discuss the notion of a stakeholder in healthcare. It suffices here to say that these are the people legitimately involved in healthcare such as the patient, physician, and emergency medical staff. In some definitions stakeholders are the only people who can access the patient record. There are usually a special provisionings for the emergency care staff to access the patient data without an explicit informed consent in the event that the patient is unconscious. 

Integrated Management System. It includes procedures for documentation control, control of records and internal communication. It is interconnected with the rest of the system blocks. 

The supplier should establish and maintain procedures for the control of records relating to source contents, identification and the original purchaser. These procedures should include a description of the applicable records and procedures for indexing, storage, maintenance and disposition. 

If the detection system is an electronic, area detector, the crystal may be mounted with a convenient crystal direction parallel to an axis about which it may be rotated under tlie control of a computer that also records the diffracted intensities. Because tlie orientation of the crystal is known at the time an x-ray photon or neutron is detected at a particular point on the detector, the indices of the crystal planes causing the diffraction are uniquely detemiined. If... 

In addition, most devices provide operator control of settings for temperature and/or response slope, isopotential point, zero or standardization, and function (pH, mV, or monovalent—bivalent cation—anion). Microprocessors are incorporated in advanced-design meters to faciHtate caHbration, calculation of measurement parameters, and automatic temperature compensation. Furthermore, pH meters are provided with output connectors for continuous readout via a strip-chart recorder and often with binary-coded decimal output for computer interconnections or connection to a printer. Although the accuracy of the measurement is not increased by the use of a recorder, the readabiHty of the displayed pH (on analogue models) can be expanded, and recording provides a permanent record and also information on response and equiHbrium times during measurement (5). 

Finance. Cost accounting, budget control, payroU, records, accounts payable, accounts receivable, capital equipment control, taxes, customs, iasurance, loss control, and management information are all part of the finance function. 

Fluorometry and Phosphorimetry. Modem spectrofluorometers can record both fluorescence and excitation spectra. Excitation is furnished by a broad-band xenon arc lamp foUowed by a grating monochromator. The selected excitation frequency, is focused on the sample the emission is coUected at usuaUy 90° from the probe beam and passed through a second monochromator to a photomultiplier detector. Scan control of both monochromators yields either the fluorescence spectmm, ie, emission intensity as a function of wavelength X for a fixed X, or the excitation spectmm, ie, emission intensity at a fixed X as a function of X. Fluorescence and phosphorescence can be distinguished from the temporal decay of the emission. 

The activity of ivermectin against the filarial parasite Dirofilaria immitis in dogs suggested a possible role for the control of filarial parasites of humans (20). It has been extensively tested in human onchocerciasis and is now considered to be the dmg of choice. In a single yearly oral dose, it suppresses microfilariae in the skin and eyes and, in most cases, prevents the progression of the disease to blindness. Table 4 shows the results of a 30-patient double-blind study recorded over one year. 

Control of Dyeing Equipment. Over the years, the dyer and machinery manufacturer have appHed any mechanical or electrical equipment that would enable them, day after day, to produce repeatable dyeings of top quaHty. First, thermometers were installed in dye lines these soon evolved into thermocouples with remote recording. Other improvements were soon developed, such as automatic four-way valves with variable-interval controls, flow controls, pressure recorders, hydrauHc and air pressure sets on roUers, pH controls, etc. 

Fluid couplings have a proven record of reliability and ease of operation. They thus have found wide application wherever a light load start and capticily control of drives is required as in fans and pumps. 

Records results of environmental monitoring data flows, pH, pollution levels, waste disposal areas and control of pollution. 

This clause requires the designation of special characteristics that should have been accomplished during product realization (as required by clause 4.2.4.7). As for the documentation of special characteristics, the symbols should have been applied both when establishing the process controls and preparing the control plan (also clause 4.2.4.7) and associated documentation during the planning phase. Therefore the requirements not previously addressed are for the control of special characteristics and evidence of compliance i.e. quality records. 

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