No 10 The Application of the Principles of GLP to Computerised Systems(1995)
EMA GMP数据完整性问答(中英对照版)(2016.08)
EMA Data integrity Q&A (NEW August 2016)EMA数据完整性问答（2016年8月）1. How can data risk be assessed?1. 如何评估数据风险？Data risk assessment should consider the vulnerability of data to involuntary ordeliberate amendment, deletion or recreation. Control measures which preventunauthorised activity and increase visibility / detectability can be used as riskmitigating actions.数据风险评估应考虑无意或有意修改、删除或重建数据导致的隐患。
可通过实施预防未授权活动的控制措施，以及增加可见性/可检测性来减少风险。
Examples of factors which can increase risk of data integrity failure includecomplex, inconsistent processes with open-ended and subjective outcomes. Simple tasks which are consistent, well-defined and objective lead to reduced risk.导致增加数据完整性风险的例子包括：结果开放主观的复杂且不一致的过程。
一致、定义明确并且客观的简单任务风险较小。
Risk assessment should include a business process focus (e.g. production, QC) and not just consider IT system functionality or complexity. Factors to consider include:风险评估应包括对业务（例如生产、QC）的关注，不能仅考虑IT系统的功能或复杂性。
欧盟OMCL计算机化系统的验证附件1：自主开发软件验证
200907 PA/PH/OMCL(08)87 2R 欧盟OMCL计算机化系统的验证附件1：自主开发软件验证（中英文）OMCL Network of the Council of EuropeQUALITY ASSURANCE DOCUMENTPA/PH/OMCL (08) 87 2RVALIDATION OF COMPUTERISED SYSTEMS计算机化系统的验证ANNEX 1: VALIDATION OF COMPUTERISED CALCULATION SYSTEMS: EXAMPLE OFVALIDATION OF IN-HOUSE SOFTWARE附件1：计算机化计算系统的验证：自主开发软件的验证举例This document should be considered as a guide to OMCLs for planning, performing and documenting the validation of their computerised systems. It should not be taken as a list of compulsory requirements. It is left to the professional judgement and background experience of each OMCL to decide on the most relevant procedures to be undertaken in order to give evidence that their computerised systems are working properly and are appropriate for their intended use.本文件应作为OMCL在计划、实施和记录其计算机化系统时的指南。
它不应被当成一个强制的要求。
光通信必读优秀书籍
非线性光学部分介质在强激光场作用下产生的极化强度与入射辐射场强之间不再是线性关系，而是与场强的二次、三次以至于更高次项有关，这种关系称为非线性。
凡是与非线性有关的光学现象称为非线性光学现象，属于非线性光学的研究内容。
非线性光学一方面研究光辐射在非线性介质中传播时由于和介质的非线性相互作用自身所受的影响，另一方面则研究介质本身在光场作用下所表现出的特性。
在光通信中，主要是进入高速通信，10g，尤其是40G，随着入纤光功率的增强，非线性效应逐渐显现，系统设计必须加以考虑这方面的影响，于是在40G里面变出现了形形色色的编码。
以下切入正题1、《Nonlinear Fiber Optics》和《Applications of Nonlinear Fiber Optics》Agrawl ，这2本书从书名大家应该也可以看出是偏重于光纤通信应用的，目前第一个已经到第四版，第二个为第二版了，包括中译本，论坛都有，大家可以搜索下就可以都看到了。
/viewthread. ... =nonlinear%2Boptics/viewthread. ... =nonlinear%2Boptics2、Boyd W.R的《nonlinear optics》3rdW. Boyd教授在2002年被任命为Rochester大学M. Parker Givens Professor of Optics，lz发的应该是第二版，该书1992年第一版，第二版在第一版的基础上增加了很多新内容，并对以前的内容做了不少修订，在2008年的4月，该书又出了第三版。
整体来说，该书内容比较深，学校里的高年级研究生和一般研究人员可参考。
W.Boyd今年5月份曾代表美国光学学会来南京开会下载链接：/viewthread. ... =nonlinear%2Boptics3、华裔学者沈元镶的《非线性光学原理》沈是这方面非常牛b的，他的导师算是非线性光学方面的开创者吧，并因此获得了诺贝尔奖。
捷进英语B2U6PPT课件
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Sense and Memory
译 文
时间 随着年龄的增长， 时间似乎过得越来越快，这是因为我们日复一日地做着同 样的事情，过着同样的生活。第一次做某件事情通常会给我们留下深刻的记 忆。还记得你第一天上学或第一天上班吗？但一旦我们重复这些事情，便不 会再产生深刻的记忆，时间也就过得快了。
Time The reason time seems to go more quickly as we get older is that we
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emotion
Back to Vocabulary
n. 情感；情绪
e.g. How do you manage your emotion?
你是怎样调整情绪的呢？
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particularly
Back to Vocabulary
adv. 尤其；特别
e.g. I particularly like wooden furniture.
Sense and Memory
译 文
感官与记忆
你有过这些经历吗？ • 你正在校园里散步，突然一种熟悉的味道使你想起你的祖母，你开始想家了。 • 随着年龄的增长，你感到日子过得飞快。 • 你准备听讲座时听到一首歌，然后它就整天在你耳边回响。 事实上，我们的感官和记忆之间的关系之密切远超过我们的想象。
cr2详解(3M注释版)
Practice Test #2 Critical Reasoning (68 Questions)1. (24021-!-item-!-188;#058&000691)On Pacific islands, a newly arrived gecko species, the house gecko, is displacing the previously established mourning gecko in urban areas, but populations of the two species are more stable in rural areas far from human settlement. The house gecko does not attack the mourning gecko, but in areas where insects congregate it prevents the mourning gecko from feeding on them.Which of the following contributes most to an explanation of the difference between gecko populations in urban and rural areas?农村，离Human settlement远，population越stable在Insects聚集的地方HG不让MG吃虫问城市和农村为啥HG和MG的population差距大？方法：搭桥(A) In urban areas, geckos are valued because they eat so many insects.(B) Geckos defend territories against other members of the same species.(C) House geckos that arrive on islands are carried there in boats and planes.(D) In places where there are lighted buildings, insects tend to gather around the light.(E) Mourning geckos are all females and reproduce asexually, but house geckos reproduce sexually.2. (24069-!-item-!-188;#058&000703)Downtown Villieu was once a flourishing business district, but most Villieu-area businesses are now located only in the suburbs. The office buildings downtown lack the modern amenities most business operators demand today. To lure more businesses downtown, Villieu officials plan to have several modern office buildings constructed and to offer reduced local tax rates to any business that leases space in a new downtown building.Which of the following, if true, most threatens the plan's likelihood of success?Reduce local tax rates来勾引business去downtown(A) Most of the businesses currently located in downtown Villieu have long-term leases on the space they occupy there.(B) The existing office buildings in downtown Villieu have, on average, a much higher vacancy rate than do office buildings in Villieu's suburbs.(C) The local tax rates in Villieu's suburbs are significantly lower than downtown Villieu's proposed rate for businesses that lease space in the new office buildings.(D) Most of the businesses that currently lease office space in downtown Villieu also lease office space in Villieu's suburbs.(E) With the new office buildings, downtown Villieu would have a greater amount of modern office space than any other downtown business district in the region.3. (24117-!-item-!-188;#058&000708)Northern Air has dozens of flights daily into and out of Belleville Airport, which is highly congested. Northern Air depends for its success on economy and quick turnaround and consequently is planning to replace its large planes with Skybuses, whose novel aerodynamic design is extremely fuel efficient. The Skybus' fuel efficiency results in both lower fuel costs and reduced time spent refueling.Which of the following, if true, could present the most serious disadvantage for Northern Air in replacing their large planes with Skybuses?NA成功在于经济和快速的调度把原来的large飞机换成SB机，因为省油和节约加油时间他因(A) The Skybus would enable Northern Air to schedule direct flights to destinations that currentlyrequire stops for refueling.加强(B) Aviation fuel is projected to decline in price over the next several years.加强(C) The fuel efficiency of the Skybus would enable Northern Air to eliminate refueling at some of its destinations, but several mechanics would lose their jobs.不关人道主义的事情(D) None of Northern Air's competitors that use Belleville Airport are considering buying Skybuses.跟别人无关(E) The aerodynamic design of the Skybus causes turbulence behind it when taking off that forces other planes on the runway to delay their takeoffs.4. (24257-!-item-!-188;#058&001200)Which of the following most logically completes the argument?A new machine for harvesting corn will allow rows to be planted only fifteen inches apart, insteadof the usual thirty inches. Corn planted this closely will produce lower yields per plant. Nevertheless, the new machine will allow corn growers to double their profits per acre because__________.原来30，现在15，密了—>每株产量少了，但是会更profit每acre翻倍(A) with the closer spacing of the rows, the growing corn plants will quickly form a dense canopyof leaves, which will, by shading the ground, minimize the need for costly weed control and irrigation注意这里的costly(B) with the closer spacing of the rows, corn plants will be forced to grow taller because ofincreased competition for sunlight from neighboring corn plants高不高跟profit没有关系(C) with the larger number of plants growing per acre, more fertilizer will be required削弱(D) with the spacing between rows cut by half, the number of plants grown per acre will almost double这个不能翻倍，因为单株产量降低了(E) with the closer spacing of the rows, the acreage on which corn is planted will be utilized much more intensively than it was before, requiring more frequent fallow years in which corn fields are left unplanted不管环保的事情5. (24305-!-item-!-188;#058&001204)Microscopic plants called algae grow inside the top layer of sea ice in the Antarctic if enough sunlight reaches that layer of ice and enough seawater, which contains nutrients, reaches that layer after splashing onto the surface. Even though moderate snow cover reduces the sunlight that filters into the top layer, sea ice with moderate snow cover typically contains even more algae in the top layer than does sea ice with less snow cover.Which of the following, if true, most helps to explain the apparent discrepancy?两个条件：阳光和营养水盖上雪，阳光相对少，但是A却更多了，为啥？(A) As the weight of accumulated snow forces ice lower in the water, more seawater splashes onto the surface and seeps through the snow.营养水更多了(B) Seawater in the Antarctic often contains higher concentrations of nutrients than does seawater in more temperate regions.无关比较(C) As the air temperature around sea ice decreases during the winter, the likelihood decreases that snow will fall and thus add to any existing snow cover.(D) The nutrients on which algae rely are common in seawater throughout the Antarctic.(E) More sunlight filters through a layer of ice than through an equally thick layer of snow.无关比较6. (24353-!-item-!-188;#058&001207)Which of the following most logically completes the passage?Garnet and RenCo each provide health care for their employees. Garnet pays for both testing of its employees' cholesterol levels and treatment of high cholesterol. This policy saves Garnet money, since high cholesterol left untreated for many years leads to conditions that require very expensive treatment. However, RenCo does not have the same financial incentive to adopt such a policy, because __________.G花钱检查并治疗，因为省钱（几年不治花费很高），R没有动机这么做，因为？方法：找不同点(A) early treatment of high cholesterol does not entirely eliminate the possibility of a stroke later in life没有不同点(B) the mass media regularly feature stories encouraging people to maintain diets that are low in cholesterol诉诸专家（media），还是没两公司不同点(C) RenCo has significantly more employees than Garnet has顾的多更应该有动机做(D) RenCo's employees are unlikely to have higher cholesterol levels than Garnet's employees不比G高，G都做了，且save了，R没有理由没有动机做(E) the average length of time an employee stays with RenCo is less than it is with Garnet题干上有for many year，这里就用上了，讲了G和R的不同7. (24401-!-item-!-188;#058&001291)United Lumber will use trees from its forests for two products. The tree trunks will be used for lumber and the branches converted into wood chips to make fiberboard. The cost of this conversion would be the same whether done at the logging site, where the trees are debranched, or at United's factory. However, wood chips occupy less than half the volume of the branches from which they are made.The information given, if accurate, most strongly supports which of the following?树枝convert chip做FB，在哪里convert的花费一样，但是chip的体积比树枝的一半还小(A) Converting the branches into wood chips at the logging site would require transporting a fully assembled wood-chipping machine to and from the site.新概念，没提到(B) It would be more economical to debranch the trees at the factory where the fiberboard is manufactured.文章讲的是convert(C) The debranching of trees and the conversion of the branches into chips are the only stages in the processing of branches that it would be in United's economic advantage to perform at the logging site. only stages，没提到(D) Transportation costs from the logging site to the factory that are determined by volume of cargo would be lower if the conversion into chips is done at the logging site rather than at the factory. Cost靠体积，体积小，花费少(E) In the wood-processing industry, branches are used only for the production of wood chips forfiberboard. E only和wood-processing industry都没有提到8. (24449-!-item-!-188;#058&001338)Which of the following most logically completes the argument?Utrania was formerly a major petroleum exporter, but in recent decades economic stagnation andrestrictive regulations inhibited investment in new oil fields. In consequence, Utranian oil exports dropped steadily as old fields became depleted. Utrania's currently improving economicsituation, together with less-restrictive regulations, will undoubtedly result in the rapiddevelopment of new fields. However, it would be premature to conclude that the rapid development of new fields will result in higher oil exports, because __________.U是主要出口城市，受到两个原因影响导致老油田衰竭，出口下降，随着这些因素的消失，出口并不会增加，为什么？(A) the price of oil is expected to remain relatively stable over the next several years(B) the improvement in the economic situation in Utrania is expected to result in a dramatic increase in the proportion of Utranians who own automobiles(C) most of the investment in new oil fields in Utrania is expected to come from foreign sources(D) new technology is available to recover oil from old oil fields formerly regarded as depleted(E) many of the new oil fields in Utrania are likely to be as productive as those that weredeveloped during the period when Utrania was a major oil exporterA price无关B 经济好转导致城内用车多了，产量增加并不一定导致出口增加C 投资哪里来的对出口没有影响D 加强E 加强9. (24497-!-item-!-188;#058&001429)Beta Corporation claims that it no longer has enough work for the 60 computer data-entry workers that it is laying off. These workers have heard, however, that the company is buying 100 new computers. So the workers concluded that the company's real reason for laying them off is to fill their jobs with lower-paid workers.Which of the following, if true, would most undermine the workers' conclusion?因为买了100个新电脑，所以有工作给他们做(A) Most of the workers being laid off know how to enter data on a number of different computer systems.(B) Orders for almost all of Beta Corporation products have increased over the past year.(C) A recent memorandum from the president of Beta Corporation requested that all data generated by the company be stored in computerized form.加强了(D) Beta Corporation's computer data-entry workers are more experienced and hence more highly paid than people doing comparable work in other companies.(E) Beta Corporation's new computers will allow its current management and sales staff to perform many of the tasks that the data-entry workers were previously doing.10. (24867-!-item-!-188;#058&001810)Which of the following most logically completes the passage?For the past several years, a certain technology has been widely used to transmit data among networked computers. Recently two data transmission companies, Aptron and Gammatech, have each developed separate systems that allow network data transmission at rates ten timesfaster than the current technology allows. Although the systems are similarly priced and are equally easy to use, Aptron's product is likely to dominate the market, because __________.A和G研发系统，速度快，价格类似，但是A会占领市场，因为？找G不利的理由，以及A和G的不同(A) Gammatech has been in the business of designing data transmission systems for several years more than Aptron has 在市场的时间说明nothing(B) the number of small businesses that need computer networking systems is likely to double over the next few years，small business会加倍没有说A和G的不同(C) it is much more likely that Gammatech's system will be expandable to meet future needs，加强(D) unlike many data transmission companies, Aptron and Gammatech develop computers inaddition to data transmission systems，A和G的相同，不是区别(E) it is easier for users of the current data transmission technology to switch to Aptron's product than to Gammatech's11. (24915-!-item-!-188;#058&001837)Radio stations with radio data system (RDS) technology broadcast special program information that only radios with an RDS feature can receive. Between 1994 and 1996, the number of RDS radio stations in Verdland increased from 250 to 600. However, since the number ofRDS-equipped radios in Verdland was about the same in 1996 as in 1994, the number of Verdlanders receiving the special program information probably did not increase significantly. Which of the following is an assumption on which the argument depends?Station数量多了接收器不变 接受info的人数量不变(A) Few if any of the RDS radio stations that began broadcasting in Verdland after 1994 broadcast to people with RDS-equipped radios living in areas not previously reached by RDS stations.含有not,加上很长，优先选择，意思是few（理解为没有）S在94年后开始为原来有radio，但是原来的S不能达到的人播放(B) In 1996 most Verdlanders who lived within the listening area of an RDS station already had a radio equipped to receive RDS. 但是RDS数量没有增加，没比较(C) Equipping a radio station with RDS technology does not decrease the station's listening area.没影响，没比较(D) In 1996 Verdlanders who did not own radios equipped to receive RDS could not receive any programming from the RDS radio stations that began broadcasting in Verdland after 1994.重复文章的premises(E) The RDS radio stations in Verdland in 1996 did not all offer the same type of programming.没有对比12. (24967-!-item-!-188;#058&001893)Situation: For five years the Souper restaurant chain has maintained rapid sales growth in Danport, primarily by opening new restaurants that draw patrons away from other restaurants in their vicinity.Goal: Souper wishes to achieve continued rapid sales growth in Danport over the next two years.Proposal for consideration: Continue to open new restaurants in Danport during the next two years at the same rate as in the last two years.In light of the situation, which of the following, if true, most strongly argues that adopting the proposal would be an ineffective way of achieving the goal?以前成功，用同样的方法来保证以后成功解题：时地不全等(A) At times at which customers find Souper restaurants too crowded, they often go to other restaurants nearby. 加强(B) The Souper chain has generally opened new restaurants in locations that are in the vicinity of a large number of other restaurants.以前是，不能保证以后是(C) Souper restaurants generally offer a much smaller variety of foods than many of the other restaurants in their vicinity.提供啥没关系，只要能卖出去(D) Virtually all potential sites for new Souper restaurants in Danport are located in the vicinity of existing Souper restaurants.所有的可以开店的地方都已经有了这个店，开新店会形成竞争(E) Souper restaurants have always offered meals that are somewhat less expensive than meals at restaurants that compete with Souper for patrons.这个不会随着时间改变改变的，所以是加强13. (25752-!-item-!-188;#058&002668)An unusually severe winter occurred in Europe after the continent was blanketed by a blue haze resulting from the eruption of the Laki Volcano in the European republic of Iceland in the summer of 1984. Thus, it is evident that major eruptions cause the atmosphere to become cooler than it would be otherwise.Which of the following statements, if true, most seriously weakens the argument above?EU的夏天火山爆发导致冬天寒冷 大部分火山爆发导致变冷（比正常情况）(A) The cooling effect triggered by volcanic eruptions in 1985 was counteracted by an unusual warming of Pacific waters. 相当于支持(B) There is a strong statistical link between volcanic eruptions and the severity of the rainy season in India.下雨不是冷，偷换概念(C) A few months after El Chichn's large eruption in April 1982, air temperatures throughout the region remained higher than expected, given the long-term weather trends.对（反例）(D) The climatic effects of major volcanic eruptions can temporarily mask the general warming trend resulting from an excess of carbon dioxide in the atmosphere.支持(E) Three months after an early springtime eruption in South America during the late 19th century, sea surface temperatures near the coast began to fall.支持14. (25938-!-item-!-188;#058&002908)Most household appliances use electricity only when in use. Many microwave ovens, however, have built-in clocks and so use some electricity even when they are not in use. The clocks each consume about 45 kilowatt-hours per year. Therefore, households whose microwave oven has no built-in clock use 45 kilowatt-hours per year less, on average, than do comparable households whose microwave oven is otherwise similar but has a built-in clock.Which of the following is an assumption on which the argument depends?没有clock在炉子上的用户会少用45 kilowatt-hours per year电比带clock的(A) Households that do not have a microwave oven use less energy per year, on average, than do households that have a microwave oven.比较对象错(B) Microwave ovens with a built-in clock do not generally cost more to buy than microwave ovens without a built-in clock.用电的比较，不是炉子价格的比较(C) All households that have a microwave oven also have either a gas oven or a conventional electric oven.不是assumption，有没有这些没有影响(D) Households whose microwave oven does not have a built-in clock are no more likely to have a separate electric clock plugged in than households whose microwave oven has one.(E) There are more households that have a microwave oven with a built-in clock than there are households that have a microwave oven without a built-in clock. 哪个数量多没有影响15. (25986-!-item-!-188;#058&002914)Some airlines allegedly reduce fares on certain routes to a level at which they lose money, in order to drive competitors off those routes. However, this method of eliminating competition cannot be profitable in the long run. Once an airline successfully implements this method, any attempt to recoup the earlier losses by charging high fares on that route for an extended period would only provide competitors with a better opportunity to undercut the airline's fares.Which of the following, if true, most seriously weakens the argument?降价赶走竞争者的方法不能长期盈利，因为想提价的时候会给竞争者更好的降价的机会(A) In some countries it is not illegal for a company to drive away competitors by selling a product below cost.(B) Airline executives generally believe that a company that once underpriced its fares to drive away competitors is very likely to do so again if new competitors emerge. 杀鸡儆猴(C) As part of promotions designed to attract new customers, airlines sometimes reduce their ticket prices to below an economically sustainable level.(D) On deciding to stop serving particular routes, most airlines shift resources to other routes rather than reduce the size of their operations.能调走，也能调回来(E) When airlines dramatically reduce their fares on a particular route, the total number of air passengers on that route increases greatly.16. (26678-!-item-!-188;#058&003277)When an airplane is taken out of service for maintenance, it is often repainted as well, and during the repainting no other maintenance work can be done on the plane. In order to reduce maintenance time, airline officials are considering using a new nontoxic plastic film instead of paint. The film takes just as long to apply as paint does, but many other maintenance tasks can be carried out at the same time.Which of the following, if true, is further evidence that using the film will help the airline officials achieve their goal?用film节约maintenance的时间(A) Unlike paint, the film gives a milky tone to certain colors. 不管时间事情(B) At the end of its useful life, the film can be removed much more quickly than paint can.(C) The film can be applied only by technicians who have received special training. 没有时间(D) The metal exteriors of airplanes have to be protected from high temperatures and caustic chemicals such as exhaust gases. 没有时间(E) Even at speeds considerably higher than the normal speed of a passenger jet, the film remains securely attached.没有时间17. (26864-!-item-!-188;#058&003368)At present the Hollywood Restaurant has only standard-height tables. However, many customers come to watch the celebrities who frequent the Hollywood, and they would prefer tall tables with stools because such seating would afford a better view of the celebrities. Moreover, diners seated on stools typically do not stay as long as diners seated at standard-height tables. Therefore, if the Hollywood replaced some of its seating with high tables and stools, its profits would increase.The argument is vulnerable to criticism on the grounds that it gives reason to believe that it is likely that喜欢长腿的，因为视线好，可以看名人，但是呆的时间不比普通的长。
COA
COA考试资料前二章作业1.计算机的四个基本功能（Functions）是什么？(P6带圆点处)2.在计算机的top-level structure view中，四个structuralcomponents 是什么？P10 Figure 1.43.谁提出了store-program concept ?(P17)你能用汉语简单地描述这个存储程序的概念吗？4.CPU的英文全称是什么(P9)？汉语意义是什么？P11CPU构造Figure 1.55.ALU的英文全称是什么？汉语意义是什么？(P9)6.V on Neumann 的IAS机的五大部件都是什么？(P20带圆点处)7.在第一章中我们认识到的四个结构性部件（第2题）与V on Neumann的IAS机（第6题）中部件有本质差别吗？8.Fundamental Computer Elements 有哪几个（P28 figure2.6）？它们与计算机的四个基本功能的关系是什么？9.Moore’s Law在中文翻译为什么？它描述了什么事物的一般规律？(P24 double every 18 months)10.本书的次标题和第二章第二节标题均为“Designing forPerformance”,Performance 主要指什么(P37 带圆点处)？Performance Balance的（balance）平衡要平衡什么（P38）？11.本书作者将他要研究的范围局限在“desktop,workstation , server“中，它们的中文名称是什么(桌面体、工作站和服务器)？各自的工作范围是什么？(P37)Chapter 3Homework1.PC means _ （P53 相关的IR 、MAR、MBR 、I/O、AR、I/OBR means牢记）A. personal computerB. programming controllerC. program counterD. portable computerPC——存放下一条指令的地址（address of next instruction）MAR——存放本条指令的地址(address of the instruction) MBR——存放取得的内容(comtents )2. PC holds AA. address of next instructionB. next instructionC. address of operandD. operand3. At the end of fetch cycle, MAR holds ___(P54 fetch cycle 的步骤，对应12章的内容P422)A. address of instructionB. instructionC. address of operandD. operand4. Interrupt process steps are __P61（相当重要）A. suspending , resuming , branching & processingB. branching , suspending , processing & resumingC. suspending , branching , processing & resumingD. processing , branching , resuming & suspending5. A unsigned binary number is n bits, so it is can represent a value in the range between _________ .（未带符号）A. 0 to n-1B. 1 to nC. 0 to 2n-1D. 1 to 2n6.The length of the address code is 32 bits, so addressing range (or the range of address) is ________________. (1K=210B1M=210K 1G=210M)A. 4GB.from –2G to 2GC.4G-1D. from 1 to 4G7.There are three kinds of BUSes. Which is not belong to them?(P70 Figure 3.16)A. address busB. system busC. data busD. control bu第四章一：选择题1.The computer memory system refers to __(P97 区分Internal Memory和External memory)_A.RAM Internal Memory(内部存储器)——register,main memory,acheB.ROM External memory（外部存储器）——diskC.Main memoryD.Register , main memory, cache, external memory2.If the word of memory is 16 bits, which the following answer is right ?A.The address width is 16 bitsB.The address width is related with 16 bitsC.The address width is not related with 16 bitsD.The address width is not less than 16 bits3.The characteristics of internal memory compared to external memory(P100 figure4.1 图中从上往下看：速度变慢，容量增大，单位成本降低)A.Big capacity, high speed, low costB.Big capacity, low speed, high costC.small capacity, high speed, high costD.small capacity, high speed, low cost4．On address mapping of cache, any block of main memory can be mapped toany line of cache, it is （P107~117 ）总结映射：Direct Mapping——fixed main memory be mapped to fixed line of cacheAssociative Mapping——any block of main memory can be mapped to any line of cache,Set Associative Mapping——the data in any block of main memory can be mapped to fixed set any l(way) of cacheA) Associative Mapping B) Direct MappingC) Set Associative Mapping D) Random MappingP118 总结写策略：write through——as well as to cacheWrite back——when the difference between cache and main memory is found5. Cache’s write-through polity means write operation to main memory _______.A)as well as to cacheB)only when the cache is replacedC)when the difference between cache and main memory is foundD)only when direct mapping is used6.Cache’s write-back polity means write operation to main memory ______________.a)as well as to cacheb)only when the relative cache is replacedc)when the difference between cache and main memory isfoundd)only when using direct mapping7. O n address mapping of cache, the data in any block of mainmemory can be mapped to fixed line of cache, it is _________________.A)associative mapping B) directmappingC)set associative mapping D) randommapping8.On address mapping of cache, the data in any block of main memory can be mapped to fixed set any line(way) of cache, it is _________________.B)associative mapping B) directmappingD)set associative mapping D) randommapping二：计算题(from page 126)Problem 4.1 , Problem 4.3 , Problem 4.4 , Problem 4.5 , , Problem 4.7, Problem 4.10第五章作业1.which type of memory is volatile?(P140 Table 5.1 熟记此表)A.ROMB. E2PROMC. RAMD. flash memory2.which type of memory has 6-transistor structure?（P141 Figure5.2(b)）DRAM——is made with cells that store data as charge on capacitors (read refresh circuits but slower)SRAM——binary values are stored using traditional flip-flop logic-gate configurations(faster & does not need refresh circuits)A. DRAMB. SRAMC. ROMD. EPROMing hamming code, its purpose is of one-bit error. (P150第二段)A. detecting and correctingB. detectingC. correctingD. none of all4.Flash memory is （同1）.A. read-only memoryB. read-mostly memoryC. read-write memoryD. volatile5.Which answer about internal memory is not true? （P139）A. RAM can be accessed at any time, but data would be lost when power down..B. When accessing RAM, access time is non-relation with storage location.C. In internal memory, data can’t be modified.D. Each addressable location has a unique address.Page161 Problems: 5.4 5.5 5.6 5.7 5.8第六章作业一、选择题P180~183RAID0——四个数据盘：不能纠错RAID1——四个数据盘和四个copy盘：have copy ,mirror disk that contains the same dataRAID2——四个数据盘和三个校验盘：make use lf a parallel access technique(have copy)RAID3——四个数据盘和一个校验盘：(同2)+only a single redundant （只要知道有错误，无需其位置）RAID4——四个数据盘和一个校验盘：make use of independent access techniqueRAID5——distributes the parity strips across all disksRAID6——two different parity calculations are carried out and stored in separate blocks on different disks1. RAID levels_________make use of an independent access technique.A. 2B. 3C. 4D. all2. In RAID 4, to calculate the new parity, involves _ reads_P183.(two reads & two writes )A. oneB. twoC. threeD.four3. During a read/write operation, the head is ------P164最后一段A. movingB. stationaryC. rotatingD. above all4. On a movable head system, the time it takes to position the head at the track is know as______.总结：（P171）seek time——the time it takes to position the head at the trackRotational delay——the time it takes for the beginning of the sector to reach the headAccess time—the time it takes to get into position to read or writeA. seek timeB. rotational delayC. access timeD. transfer time5. RAID makes use of stored______information that enable the recovery of data lost due to a disk failure.（P175 相关的1，2，3 点内容）A. parityB. user dataC. OSD. anyone6. Recording and retrieval via _________called a head（P167）A. conductive coilB. aluminiumC. glassD. Magnetic field7.In Winchester disk track format, _________is a unique identifier or address used to locate a particular sector.总结：ID field is a unique identifier or address used to locate a particular sector.SYNCH byte is a special bit pattern that delimits the beginning of the fieldData field holds dataDisk Data Layout:Sectors ,Tracks ,Intersector gap (各自的功能P165~166)A. SYNCHB. GapC. ID fieldD. Data field8. Data are transferred to and from the disk in ________.A. trackB. sectorC. gapD. cylinder9. In _________, each logical strip is mapped to two separate physical disk.A. RAID 1B. RAID 2C. RAID 3D. RAID 410. With _________, the bits of an error correcting code are stored in the corresponding bit position on multiple parity disk.A. RAID 1B. RAID 2C. RAID 3D. RAID 411. The write-once read-many CD, known as ___(P184~187)A. CD-ROMB. CD-RC. CD-R/WD. DVD总结：CD/CD-ROM——read only ,CD-R——write only ,CD-RW——write manyDVD——read only第七章总结：Programmed I/O（P205）——CPU periodically reads & checks the status of I/O module until it find that the operation is completeINTERRUPT-DRIVEN I/O——（P209 11个步骤）processor to issue an I/O command to a module and then go on to dosome other useful workDMA（direct memory access）——the latter technique is more common and is referred to as cycle stealing,the DMA module in effect steals a bus cycle1.“When the CPU issues a command to the I/O module, it mustwait until the I/O operation is complete”. It is programmed I/O , the word “wait” means ___a. the CPU stops and does nothingb. the CPU does something elsec. the CPU periodically reads & checks the status of I/O moduled. the CPU wait the Interrupt Request Signal2.See Figure 7.7. To save (PSW & PC) and remainder onto stack,why the operations of restore them is reversed? Because the operations of stack are __a. first in first outb. randomc. last in first outd. sequenceding stack to save PC and remainder, the reason is_______P209~210 figure 7.7a.some information needed for resuming the currentprogram at the point of interruptb.when interrupt occurs, the instruction is not executed over, sothe instruction at the point of interrupt must be executed once againc.the stack must get some information for LIFOd.the start address of ISR must transfer by stack4.The signals of interrupt request and acknowledgementexchange between CPU and requesting I/O module. The reason of CPU’s acknowledgement is _____P210 第3步a.to let the I/O module remove request signalb. to let CPUget the vector from data busc.both a & bd. other aims5.In DMA , the DMA module takes over the operations of datatransferring from CPU, it means _--P216（抓住关键词cycle stealing）第一段+带圆点处a.the DMA module can fetch and execute instructions likeCPU doesb.the DMA module can control the bus to transfer data to orfrom memory using stealing cycle techniquec.the DMA module and CPU work together(co-operate) totransfer data into or from memoryd.when DMA module get ready, it issues interrupt requestsignal to CPU for getting interrupt service6.Transfer data with I/O modules, 3 types of techniques can beused. Which one is not belong them? P204a. Interrupt-driven I/Ob. programmed I/Oc. direct I/O accessd. DMAProgrammed I/O——sending a read or write command,and transferring the dataInterrupt-driven I/O——extracting data from main memory for output and storing data in main memory for input DMA——I/O module and main memory exchange data directly,without processor involvement7.Think 2 types of different data transferring, to input a wordfrom keyboard and to output a data block of some sectors to harddisk. The best choice is to use ___P204a.interrupt-driven I/O and DMAb. DMA and programmed I/O C. both interrupt-driven I/Os d. both DMAsprogrammed I/O——read/write one word one timeinterrupt-driven I/Os——read/write a block of dataDMA——read/write a block of dataparing with interrupt-driven I/O, DMA further raises theusage rate of CPU operations, because ___P209 P219a. it isn’t necessary for CPU to save & restore sceneb. itisn’t necessary for CPU to intervene the dada transferc. it isn’t necessary for CPU to read & check status repeatedlyd. both a and bDMA 与Programmed I/O比较则选C第九章1.Suppose bit long of two’s complement is 5 bits, which arithmetic operation brings OVERFLOW? P288 (-2n-1~2n-1-1) A. 5+8 B. (-8)+(-8)C. 4-(-12)D.15-72.Overflow occurs sometime in ______arithmetic operation.P293A. addB. subtractC. add and subtractD. multiply3. In twos complement, two positive integers(正整数) are added, when does overflow occurs?(同号相加，如果符号相反则overflow) P293A. There is a carryB. Sign bit is 1C. There is a carry, and sign bit is 0D. Can’t determine4. An 8-bit twos complement 1001 0011 is changed to a 16-bit that equal to____.(n位码变为m位码，只需将原符号位向左重复写（m-n）位)A.1000 0000 1001 0011B. 0000 0000 1001 0011C.1111 1111 1001 0011D.1111 1111 0110 1101 115. An 8-bit twos complement 0001 0011 is changed to a 16-bit that equal to____.（同4）A. 1000 0000 1001 0011B. 0000 0000 0001 0011C. 1111 1111 0001 0011D. 1111 1111 1110 11016.Booth’s algorithm is used for Twos complement ___P301Block Diagram of Hardware for Addition and Subtraction P296 figure9.6Flowchart for Unsigned Binary Multiplication P298 figure9.9Booth's Algorithm for Twos complement P301 figure 9.12Flowchart for Unsigned Binary Division P305 figure9.16A. additionB. subtractionC. multiplicationD. division7. In floating-point arithmetic, addition can divide to 4 steps:______.A. load first operand, add second operand, check overflow and store resultB. compare exponent, shift significand, add significands and normalizeC. fetch instruction, indirectly address operand, execute instruction and interruptD. process scheduling states: create, get ready, is runningand is blocked8. In floating-point arithmetic, multiplication can divide to 4 steps: ______.A. load first operand, add second operand, check overflow and store resultB. fetch instruction, indirectly address operand, execute instruction and interruptC. process scheduling states: create, get ready, is runningand is blockedD. check for zero, add exponents, multiply significands, normalize, and round.9.The main functions of ALU are?A. LogicB. ArithmeticC. Logic and arithmeticD. Only addition10. Which is true?A. Subtraction can not be finished by adder and complement circuits in ALUB. Carry and overflow are not sameC.In twos complement, the negation of an integer can be formedwith the following rules: bitwise not (excluding the sign bit), and add 1.D. In twos complement, addition is normal binary addition,but monitor sign bit for overflowChapter 10 and Chapter 11(寻址方式)P（383）Table 11.1 Basic Addressing Modes (disadvatage & advatage)Immediate——no memory access in execution cycle ,very fast,but value range limited and operand no-normal Direct——one times memory access in execution cycle,but address length(range) limitedIndirect——two times memory access (slow), operand normal ,value range non-limited,address length(range) non-limitedRegister——no memory access(fast),operand normal(value no limited),address length limited(address range very litter ) Register indirect——one times memory access operand normal(value range non-limited ),address length non-limited(address length very large) Displacement——one times memory access(value non-limited),address calculation complex1: In instruction, the number of addresses is 0, the operand(s)’address is implied, which is(are) in_______.p334 addresses is 1——a second address must be implicit to ACaddresses is 2——one address does double duty both an operand and a resultaddresses is 3——one address ,two operandsA. accumulatorB. program counterC. top of stackD. any register2: Which the following addressing mode can achieve the target of branch in program?(p387)A.Direct addressing modeB.Register addressing modeC.Base-register addressing modeD.Relative addressing mode3: In index-register addressing mode , the address of operand is equal toA.The content of base-register plus displacementB.The content of index-register plus displacementC.The content of program counter plus displacementD.The content of AC plus displacement4: The address of operand is in the instruction, it is_________ ?A.Direct addressing modeB.Register indirect addressing modeC.Stack addressing modeD.Displacement addressing mode5: Which the following is not the area that the source and result operands can be stored in ?(p331)A.Main or virtual memoryB.CPU registerC.I/O deviceD.Instruction6: Compared with indirect addressing mode , the advantage of register indirect addressing mode isrge address spaceB.Multiple memory referenceC.Limit address spaceD.Less memory access7:With base-register ADDRESSING , the ______________ register can be used.A.BASEB. INDEX Relative addressing——PCC. PCD. ANY Indexing——Index-Register8:The disadvantage of INDIRECT ADDRESSING is ____________.A. large addressing rangeB. no memory accessC. more memory accessD. large value range9:Which is not an advantage with REGISTER INDIRECT?A. just one times of operand’s accessB. large memory spaceC. large value rangeD. no memory reference10:The REGISTER ADDRESSING is very fast, but it has _________________.A. very less value rangeB. very less address spaceC. more memory accessD. very complex address’calculating11:The disadvantage of IMMEDIATE ADDRESSING is ___________.A. limited address rangeB. more memory accessC. limit value rangeD. less memory access12:In instruction, the number of addresses is 2, one address does double duty both _______________.A.a result and the address of next instructionB.an operand and a resultC.an operand and the address of next instructionD.two closed operands13.In instruction, the number of addresses is 3, which are ____A. two operands and one resultB. two operands and an address of next instructionC. one operand, one result and an address of next instructionD. two operands and an address of next instruction14.The address is known as a type of data, because it is represented by ___(p337)Address——unsigned integersNumbers——integer or fixed point ,fleating point, decimalA. a number of floating pointB. a signed integerC. an unsigned integerD. a number of hexadecimal15.Which is not a feature of Pentium .A. complex and flex addressingB. abundant instruction setC. simple format and fixed instruction lengthD. strong support to high language16. Which is not a feature of Power PC .A. less and simple addressing modeB. basic and simple instruction setC. variable instruction length and complex formatD. strong support to high languageChapter 12 and Chapter 181. After the information flow of fetch subcycle, the content of MBR is_____________.A.oprandB.address of instructionC. instructionD. address of operand2. After the information flow of instruction subcycle, the content of MBR is_____________.A.oprandB.address of instructionC. instructionD. address of operand3. The worse factor that limits the performance of instruction pipeline is _________________.A.conditional branch delaying the operation of target addressB. the stage number of pipeline can’t exceed 6C. two’s complement arithmetic too complexD. general purpose registers too few4.The most factor to affect instruction pipeline effectiveness is __________.A. The number of stagesB. the number of instructionC. the conditional branch instructionD. the number ofpipelines5. RISC rejects ______.(p463带圆点)A. few, simple addressing modesB. a limited and simple instruction setC. few, simple instruction formatsD. a few number of general purpose registers6. RISC rejects ______.（同上题）A.a large number of general-purpose registersB. indirect addressingC. a single instruction sizeD. a small number of addressing mode7. Which is NOT a characteristic of RISC processor.A. a highly optimized pipeline.B. Register to register operationsC. a large number of general-purpose registersD. acomplexed instruction format8.Control unit use some input signals to produce control signalsthat open the gates of information paths and let themicro-operations implement. Which is NOT the input signals of control unit/ P585（带圆点）+P594（input signals——instruction register,the clock,flags,and control bus signals——interrupt signals and acknowledgments）A.clock and flagsB.instruction registerC.interruptrequest signal D.memory read or write9.Control unit use some output signals to cause someoperations. Which is not included in the output signals?（P585 control signals within the processor and controlsignals to control bus)A.signals that cause data movementB.signals that a ctivate specific functions(e.g. add/sub/…)C.flagsD.read or write or acknowledgement10. Symmetric Multi-Processor (SMP) system is tightly coupled by _(p646~647NUMA——interconnect network and distributed memory)A. high-speed data-link and distributed memoryB. shared RAIDs and high-speed data-linkC. distributed caches and shared memoryD. interconnect network and distributed memory11.The SMP means __________.（P647）SISD means single instruction,single data streamSIMD means single instruction,multiple data streamMIMD means multiple instruction,multiple data streamA.Sharing Memory ProcessesB.Split Memory to PartsD.Stack and Memory Pointer D.SymmetricMulti-Processor12.The “MESI” means states of ____________ .(P659)A.Modified, Exclusive, Stored and InclusiveB.Modified, Expected, Shared and InterruptedC.Modified, Exclusive, Shared and InvalidD.Moved, Exchanged, Shared and Invalid13.The protocol “MESI”is also called ____(P659 )manyreaders but only one writer at a timeA. write back policyB. write-update protocolC. write-invalidate protocolD. write through policyChapter 121.Which register is user –visible but is not directly operatedin 8086 ?(p419 图（b）)A. DSB. SPC. IPD. BP2.The indirect sub-cycle is occurred _____________ ?（P420）Interrupt cycle 在Execute cycle 之后A. before fetch sub-cycleB. after execute sub-cycleC. after interrupt sub-cycleD. after fetch sub-cycle and before execute sub-cycle3.Within indirect sub-cycle , the thing the CPU must do is______________?A. fetch operand or store resultB. fetch operand’s address from memoryC. fetch next instruction from memoryD. nothing4.In general, which register is used for relative addressing ----the content in this register plus the A supplied by instruction to make a target address in branch or loop instructions.（P387）A. SP（stack pointer）B. IR(inex-register)C. BR(base register)D. PC5.The Memory Address Register connects to ____________BUS . (MBR_DATA BUS)A. systemB. addressC. dataD. control6.The Memory Buffer Register links to ________ BUS.A. systemB. addressC. dataD. control7.After Indirect cycle , there is a ______________ cycle .(p420Figure 12.4)A. FetchB. IndirectC. ExecuteD. Interrupt8.The Interrupt cycle is __________ ______ Execute cycle .(同上题)A. always afterB. never afterC. sometime afterD. maybe before9.The correct cycle sequence is _________________ .（同上）A. Fetch , Indirect , Execute and InterruptB. Fetch , Execute , Indirect and InterruptC. Fetch , Indirect , Interrupt and ExecuteD. Indirect , Fetch , Execute and Interrup10.The aim of the indirect cycle is to get__________________.A. an operandB. an instructionC. an address of an instructionD. an address of an operand11.Which is not in the ALU ?（P414 figure 12.2）A. shifterB. adderC. complementerD. Accumulator12.The registers in the CPU is divided _____registers and________registers .(P414 带圆点)A. general purpose , user-visibleB. user-visible（P415）, control and status（P416）C. data , addressD. general purpose ,control and status13.The Base register is a(n) __________ register in 8086.（P419 figure 12.3）A. general purposeB. dataC. addressD. control14.The Instruction Pointer is a(n) __________ register in8086.A. general purposeB. dataC. addressD. control。
计算机网络(第四版)课后习题(英文)+习题答案(中英文)
ANDREW S. TANENBAUM 秒，约533 msec.----- COMPUTER NETWORKS FOURTH EDITION PROBLEM SOLUTIONS 8. A collection of five routers is to be conn ected in a poi nt-to-poi nt sub net.Collected and Modified By Yan Zhe nXing, Mail To: Betwee n each pair of routers, the desig ners may put a high-speed line, aClassify: E aEasy, M ^Middle, H Hard , DaDeleteGree n: Importa nt Red: Master Blue: VI Others:Know Grey:—Unnecessary ----------------------------------------------------------------------------------------------ML V Chapter 1 In troductio nProblems2. An alter native to a LAN is simply a big timeshari ng system with termi nals forall users. Give two adva ntages of a clie nt-server system using a LAN.(M)使用局域网模型可以容易地增加节点。
如果局域网只是一条长的电缆，且不会因个别的失效而崩溃(例如采用镜像服务-------------------------------------------器)的情况下，使用局域网模型会更便宜。
OECD GLP Principles No. 1中英文翻译-标准操作规程
7. Standard Operating Procedures 标准操作规程
7.4Standard Operating Procedures should be available for, but not be limited to, the following categories of test facility activities. The details given under each heading are to be considered as illustrative examples. 7.4机构内的SOP应当涵盖但不局限于以下种类。 标题下的详细内容可以理解为解释性举例。
7. Standard Operating Proeference Items.供试品和对照品。 7.4.1.1Receipt, identification, labelling, handling, sampling and storage. 7.4.1.1 接收、鉴别、贴标签、存放、取样和贮存。
7. Standard Operating Procedures 标准操作规程
7.2Each separate test facility unit or area should have immediately available current Standard Operating Procedures relevant to the activities being performed therein. Published text books, analytical methods, articles and manuals may be used as supplements to these Standard Operating Procedures. 7.2机构独立的单元或区域应当有所执行操作的现 行版SOP。出版的文献、分析方法和手册可以作 为对SOP的补充材料。
WHO技术报告 No.929 2005 附件5 固定剂量复方制剂注册指导原则
WHO技术报告 No.929 2005 附件5 固定剂量复方制剂注册指导原则
缩写 1 绪论 2 1.适用范围 2 2.总体考虑 2 3.定义 8 4.注册分类 10 5.衡量固定剂量复合剂型的优缺点 10 6.固定剂量复方制剂上市许可所需要的数据 12 7.固定剂量复方制剂产品信息或说明书 24 8.上市后研究和上市后的变更 25 参考文献 26 附件1 组合包装的固定剂量复方制剂指导原则 27 附件2 判断科学文献数据是否可以被接受的原则 28 附件3 药品研发（或处方前研究） 30 附件4 优效性、等效性和非劣效性临床试验 32
缩写 AIHW Australian Institute of Health and Welfare (澳大利亚卫生与福利研究所) API Active pharmaceutical ingredient (活性药物成分) BCS Biopharmaceutics Classification Scheme (生物药学分类系统) BCS #1 Biopharmaceutics class number 1(the most favourable) (生物药学分类系统第一类)（最有利的一类） CHMP Committee for Medicinal Products for Human Use; see also CPMP (人用医疗产品委员会)（参见CPMP） CPMP Committee for Medicinal Products for Human Use (CHMP), formerly the Committee for Proprietary Medicinal Products (人用医疗产品委员会(CHMP), 前身为专利药品委员会) CPP Certificate of pharmaceutical product (药品证书) EMEA European Medicines Agency, formerly the European Medicines Evaluation Agency (欧洲药品局, 前身为欧洲药品评审局) EU European Union (欧盟) FDA Food and Drug Administration of the USA (美国食品药品管理局) FDC Fixed-dose combination (固定剂量联合用药)(见词汇表) FDC-FPP Fixed-dose combination finished pharmaceutical product (固定剂量复方药品)(见词汇表) GCP Good clinical practice (药物临床试验管理规范) GLP Good laboratory practice (药物非临床研究质量管理规范) GMP Good manufacturing practice (药品生产质量管理规范) GTDP Good trade and distribution practice (药品贸易和分销管理规范) GSP Good storage practice (药品贮存管理规范) ICH International Conference on Harmonisation (人用药品注册技术要求国际协调会议) IUTLD International Union of Tuberculosis and Lung Disease (国际抗结核病和肺病联盟) MIC Minimum inhibitory concentration (最低抑菌浓度) PP Per-protocol (a form of clinical trial design and analysis) 符合方案集（临床试验设计和分析的一种形式） SPC Summary of product characteristics (药品说明书)(见词汇表) TGA Therapeutic Good Administration (澳大利亚药品管理局)
对完善药品研制过程中数据完整性问题的思考
对完善药品研制过程中数据完整性问题的思考发表时间：2018-09-19T13:54:03.203Z 来源：《中国医学人文》2018年第7期作者：吴婧[导读] 随着我国对药品监管的日益重视，近20年来，CFDA（China Food and Drug Administration，国家食品药品监督管理总局）一直在探索改革与成长健能隆医药技术（上海）有限公司上海市 201315摘要：随着我国对药品监管的日益重视，近20年来，CFDA（China Food and Drug Administration，国家食品药品监督管理总局）一直在探索改革与成长，以严格保证药品的质量。
本文从各国法规着手，简述数据完整性的基本原则，并结合数据完整性的案例—FDA （Food and Drug Administration，美国食品药品监督管理局）警告信的分享及本公司数据完整性问题，探讨如何完善数据完整性管理。
关键词：生物制品研制企业；数据完整性；指导原则；硬件设计；软件设计；质量管理体系引言：MHRA（Medicines and healthcare products regulatory agency，英国药品和健康产品管理局）曾指出“数据完整性是制药行业保证药物质量的质量系统的基础。
”因为关键的决策，比如是否向市场发布产品（应遵循GMP—药品生产质量管理规范），是否经过临床试验证明了药品的安全性和有效性（应遵循GCP—药物临床试验质量管理规范），或者首次引入一种新的化学成分进入人体试验（应遵循GLP—应遵循）等，这些都是基于原始记录。
因此，必须确保记录（数据）的完整性与可靠性！1.数据完整性指导原则及法规介绍1.1 FDA指导原则2016年4月，FDA发布了< Data Integrity and Compliance with CGMP > (《数据完整性和CGMP的遵从性》)的草稿指南，通过18个问答从计算机系统的验证与访问权限、空白表格的控制、数据审计追踪的频率与负责部门、电子签名的管理、CGMP常规培训要求等方面具体阐述了确保数据完整的操作方法。
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GENERALDISTRIBUTIONOCDE/GD(95)115OECDSERIESONPRINCIPLESOFGOODLABORATORYPRACTICEANDCOMPLIANCEMONITORING
NUMBER10
GLPCONSENSUSDOCUMENTTHEAPPLICATIONOFTHEPRINCIPLESOFGLPTOCOMPUTERISEDSYSTEMSENVIRONMENTMONOGRAPHNO.116
ORGANISATIONFORECONOMICCO-OPERATIONANDDEVELOPMENTParis1995
COMPLETEDOCUMENTAVAILABLEONOLISINITSORIGINALFORMATOECDSERIESONPRINCIPLESOFGOODLABORATORYPRACTICEANDCOMPLIANCEMONITORING
Number10
GLPConsensusDocumentTHEAPPLICATIONOFTHEPRINCIPLESOFGLPTOCOMPUTERISEDSYSTEMS
ENVIRONMENTMONOGRAPHNO.116
EnvironmentDirectorateORGANISATIONFORECONOMICCO-OPERATIONANDDEVELOPMENTParis1995
3CopyrightOECD,1995
Applicationsforpermissiontoreproduceortranslateallorpartofthismaterialshouldbemadeto:HeadofPublicationsService,OECD,2rueAndré-Pascal,75775ParisCedex16,France.
4FOREWORDWithintheframeworkofthethirdOECDConsensusWorkshoponGoodLaboratoryPracticeheld5thto8thOctober1992,inInterlaken,Switzerland,aworkinggroupofexpertsdiscussedtheinterpretationoftheGLPPrinciplesasappliedtocomputerisedsystems.TheworkinggroupwaschairedbyDr.TheoHelderoftheDutchGLPComplianceMonitoringAuthority.TheRapporteurwasMr.BryanDoherty(ChairmanoftheComputingCommitteeoftheBritishAssociationforResearchQualityAssurance).ParticipantsintheWorkingGroupwerefrombothnationalGLPcompliancemonitoringauthoritiesandfromtestinglaboratoriesinthefollowingcountries:Austria,Belgium,Denmark,Finland,France,Germany,Japan,theNetherlands,Switzerland,UnitedKingdom,UnitedStates.ThatWorkingGroupwasunabletoreachconsensusonadetailedguidancedocumentinthetimeavailabletoit.Itdid,however,developadocumententitled"ConceptsrelatingtoComputerisedSystemsinaGLPEnvironment",whichsetoutthegeneralprinciplesanddescribedtheissuesinvolvedforeach.ThatdocumentwascirculatedtocommentstoMembercountries.
Inlightofthecommentsreceived,thePanelonGoodLaboratoryPracticeatitsfifthmeetinginMarch1993,agreedthatfurtherworkneededtobedoneandcalledforasecondworkinggroupmeetingtobeheld.UnderthechairmanshipofDr.Helder,andwithMr.Dohertyasrapporteur,thatgroupmetinParisfrom14thto16thDecember1994.ParticipantsrepresentinggovernmentandindustryfromCanada,Denmark,France,Germany,Japan,theNetherlands,Sweden,theUnitedKingdomandtheUnitedStatestookpart.
ThedraftConsensusDocumentdevelopedbytheworkinggroupwasbasedonthedocumentemanatingfromtheInterlakenworkshop,commentsfromMembercountriestheretoandadocumentdevelopedbyaUnitedKingdomjointgovernment-industryworkingparty.Itwassubsequentlyreviewed,modifiedandendorsedbythePanelandtheJointMeetingoftheChemicalsGroupandManagementCommitteeoftheSpecialProgrammeontheControlofChemicals.TheEnvironmentPolicyCommitteethusrecommendedthatthisdocumentbederestrictedundertheauthorityoftheSecretary-General.
5GLPCONSENSUSDOCUMENT:THEAPPLICATIONOFGLPPRINCIPLESTOCOMPUTERISEDSYSTEMS
Throughoutrecentyearstherehasbeenanincreaseintheuseofcomputerisedsystemsbytestfacilitiesundertakinghealthandenvironmentalsafetytesting.Thesecomputerisedsystemsmaybeinvolvedwiththedirectorindirectcaptureofdata,processing,reportingandstorageofdata,andincreasinglyasanintegralpartofautomatedequipment.Wherethesecomputerisedsystemsareassociatedwiththeconductofstudiesintendedforregulatorypurposes,itisessentialthattheyaredeveloped,validated,operatedandmaintainedinaccordancewiththeOECDPrinciplesofGoodLaboratoryPractice(GLP).
ScopeAllcomputerisedsystemsusedforthegeneration,measurementorassessmentofdataintendedforregulatorysubmissionshouldbedeveloped,validated,operatedandmaintainedinwayswhicharecompliantwiththeGLPPrinciples.
Duringtheplanning,conductandreportingofstudiestheremaybeseveralcomputerisedsystemsinuseforavarietyofpurposes.Suchpurposesmightincludethedirectorindirectcaptureofdatafromautomatedinstruments,operation/controlofautomatedequipmentandtheprocessing,reportingandstorageofdata.Forthesedifferentactivities,computerisedsystemscanvaryfromaprogrammableanalyticalinstrument,orapersonalcomputertoalaboratoryinformationmanagementsystem(LIMS)-withmultiplefunctions.Whateverthescaleofcomputerinvolvement,theGLPPrinciplesshouldbeapplied.
ApproachComputerisedsystemsassociatedwiththeconductofstudiesdestinedforregulatorysubmissionshouldbeofappropriatedesign,adequatecapacityandsuitablefortheirintendedpurposes.Thereshouldbeappropriateprocedurestocontrolandmaintainthesesystems,andthesystemsshouldbedeveloped,validatedandoperatedinawaywhichisincompliancewiththeGLPPrinciples.
Thedemonstrationthatacomputerisedsystemissuitableforitsintendedpurposeisoffundamentalimportanceandisreferredtoascomputervalidation.