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archived and appended to the patient s image data le and record Teleradiology is relatively simple to operate when no archiving is required However, when previous information on a patient must be archived and be readily accessible, the operation becomes complicated 15313 Teleradiology and PACS When the teleradiology service requires a patient s historical images as well as related information, teleradiology and PACS become very similar operationally Table 152 shows the differences between teleradiology and PACS The biggest difference between them is in the image capture methods Some current teleradiology operations still use a digitizer as the primary method of converting a lm image to digital format, although the trend is moving toward the DICOM standard In PACS, direct digital image capture is mostly done using DICOM.

Changes are unavoidable in a manufacturing setup. Manufacturers make changes at some stage of manufacturing during and after approval of a product. However, consistent quality of a drug product can only be assured through well-de ned validation procedures. When a change is made in the manufacturing process of a drug product, sponsors are responsible for evaluating the effect of any change on the safety, ef cacy, quality, stability, and potency of a drug product and ensuring that these properties are not in uenced by the change. In a manufacturing setup, various disciplines like sales, marketing, medical, regulatory affairs, manufacturing, electrical, and technical services work together. Hence, any kind of change in one discipline will have direct consequences on other disciplines. Each company should have a procedure with regard to handling a change. Quality control and quality assurance departments usually keep track of various changes occurring in a GMP environment. Therefore, it is required that personnel performing the job are trained enough to assess the effect of any kind of change or variation and take appropriate action for its evaluation or control. Supporting data should be generated and once evaluated can con rm whether further clinical or nonclinical studies are required. 1.3.5.1 Change Control

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In networking, teleradiology uses the slower speed wide area networks (WAN) compared with the Intranet, whereas the higher speed local area network (LAN) is used in PACS In teleradiology, image storage is mostly short term, whereas in PACS it is long term Teleradiology relies heavily on image compression, whereas PACS may or may not Recall Table 21 There the second column gives sizes of some common medical images In clinical applications, one single image is not suf cient for making diagnosis In general, a typical examination generates between 10 and 20 Mbytes Notice that the fourth column of Table 21 shows an average size of one typical examination in each of these image modalities The highest extreme is in digital mammography, which requires 160 Mbytes To transmit 160 Mbytes of information through WAN requires a very high-bandwidth communication technology.

f you ve ever set up a wireless network, you know that there is a great mismatch between what a manufacturer claims the range of its router or access point is, and the ability to connect to that device from different points in a home or office The range you can achieve is greatly affected by the environment Your 80211 devices may claim anywhere from 150 to 300 feet of range, but where you place your access points, residential gateways, and the computers you want to connect can have a major impact on the quality of your network Walls, ceilings, sources of RF noise like microwave ovens, 24 GHz wireless phones, other wireless networks, and other interferences lower throughput and diminish the range of your WLAN Consider these two facts.

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One major issue in teleradiology is how to transmit a very large image le through WAN with acceptable speed and cost; an example in telemammography is discussed in more detail in Section 154 1532 Teleradiology Components.

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