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Pharmaceutical product manufacturers are increasingly interested in implementing a comprehensive quality management system (QMS) and employing risk management approaches because they allow them to apply newer quality management principles that they believe enable them to more effectively assure product quality and better allow harmonization with evolving international regulatory quality system requirements The FDA has not changed the cGMP regulations but, as part of its Pharmaceutical CGMPs for the 21st Century Initiative, encourages this quality systems approach to cGMP compliance This describes outlines and discusses the regulations applicable to the QA function and unit, structure, function, charter, and application of the unit in the pharmaceutical manufacturing environment In addition, it discusses additional quality-related responsibilities that may result when manufacturers move toward a quality systems approach to quality that incorporates current quality system models to further improve quality and harmonize with international quality system requirements.

The functions of a backup archive server are twofold: maintaining the PACS continuous operation and preventing loss of image data Data loss is especially troublesome because if a major disaster occurs, it is possible to lose an entire hospital s PACS data In addition the scheduled downtimes to the main PACS archive could impact the continuity of a lmless institution s operation Few current PACS archives provides a disaster recovery scheme Furthermore current general disaster recovery solutions vary in the approach toward creating redundant copies of PACS data One novel approach is to provide a short-term fault-tolerant backup archive server using the application service provider (ASP) model at an off-site location The ASP backup archive provides instantaneous, automatic backup of acquired PACS image data and instantaneous recovery of stored PACS image data, all at a low operational cost because it utilizes the ASP business model.

The justi cation for, and execution of, the QA audit are also described, including preparation, key items of interest, a typical checklist of the audit itself, corrective and preventive actions following the audit, and suggested measures for assuring successful operation of the unit..

In addition, should the downtime event render the network communication inoperable, a portable solution is available with a data migrator The data migrator is a portable laptop with a large-capacity hard disk that contains DICOM software for exporting and importing PACS exams The data migrator can populate PACS exams that were stored in the backup archive server directly onto the clinical PACS within a couple of hours to allow the radiologists to continue to read previous PACS exams until new replacement hardware arrives and is installed or until a scheduled downtime event has been completed 1162 General Architecture.

The primary advantage of these commands over other, more straightforward compositing methods is that they allow you to access and composite the contents of individual color channels without a lot of selecting, copying and pasting, cloning, floating, and layering. You also get two extra blend modes, Add and Subtract, which may prove useful on a rainy day. The Apply Image and Calculations commands provide previewing options, so you can see how an effect will look in the image window. But thanks to the sheer quantity of unfriendly options offered by the two commands, I suggest that you use them on only an occasional basis. The Calculations command can be a handy way to combine masks and layer transparencies to create precise selection outlines. Apply Image is good for compositing images in different color models, such as RGB and Lab (as I explain in the Mixing images in different color modes section later in this chapter). But if your time is limited and you want to concentrate your efforts on learning Photoshop s most essential features, feel free to skip Apply Image and Calculations. I assure you, you won t be missing much.

Example 1 OFDM parameter selection in IEEE 802.lla: RF measurements have shown that a a typical LAN environment, the r m s delay spread at 5GHz n is on the order of 50ns, with maximum delay up to 500ns. The cyclic guard interval in 802.1la is conservatively set at 800 ns (out of each 4ps OFDM symbol interval). From (2.3), the coherence bandwith is on the order of 4MHz. The subcarrier spacing in 802.1la is chosen to be 0.3125 Mhz, which is far less than the coherence bandwidth. This setting guarantees flat fading on individual subcarriers. Out of a size 64-FFT, 12 are virtual carriers while the rest 52 subcarriers are dedicated to data (48) and pilots (4).

Sub-menus help you to organize your menu so that related commands stay together. Figure 33-6 shows the Draw menu, which has a number of sub-menus.

Figure 24-41: A bushing in 2D and 3D. The 3D bushing has been exploded but still looks the same. It can now be used to extend lines. 3. To turn the UCSORTHO system variable off, type ucsortho 0 . (If its current value is 0, just press Enter at the Enter new value for UCSORTHO <0>: prompt.) You don t want the UCS to change when you change the view in Step 5. 4. Choose Extend from the Modify toolbar or choose Modify Extend. Follow the prompts.