药品生产中计算机处理系统的验证指南

目 录

I. INTRODUCTION 绪论 II.OVERVIEW 概述 III.HARDWARE硬件

A. Types类型

1. Input Devices 输入设备 2. Output Devices 输出设备. 3. Signal Converters 信号转换器

4. Central Processing Unit (CPU) 处理单元 5. Distribution System 分布式系统 6. Peripheral Devices 外围设备 B. Key Points 关键点

1. Location 位置

2. Signal Conversion 信号转换

3. I/O Device Operation 输入/输出设备操作 4. Command Over-rides 指令中断 5. Maintenance 维护

C. Validation of Hardware硬件确认 IV.SOFTWARE软件 A. Levels分级

B. Software Identification软件验证 C. Key Points关键点

1. Software Development 软件升级 2. Software Security软件安全 D. Validation of Software软件确认

V.COMPUTERIZED OPERATIONS计算机化操作

A. Networks网络

B. Manual Back-up Systems手动备份系统 C. Input/Output Checks 输入/输出检查 D. Process Documentation过程文件

E. Monitoring of Computerized Operations计算机化操作的监视 F. Alarms报警

G. Shutdown Recovery停止恢复 VI．CGMP GUIDANCE CGMP指导 A. Hardware硬件 B. Software软件 附录：

GLOSSARY术语表

GUIDE TO INSPECTION OF

COMPUTERIZED SYSTEMS IN DRUG

PROCESSING

药品生产中计算机处理系统的验证指南

FEBRUARY, 1983

National Center for Drugs and Biologics

and

Executive Director of Regional Operations

I. INTRODUCTION 绪论

Computers are being used in increasing numbers in the pharmaceutical industry. As microprocessors become more powerful, reliable, and less expensive we can expect the proliferation of this technology, with increasing use by even very small pharmaceutical establishments.

在制药工业中，越来越多数量的计算机被使用。随着微处理器功能越来越强大，性能越来越稳定和价格越来越便宜我们可以期待这个技术被更广泛应用，甚至越来越多的被用在非常小的制药设备。 Computer systems are used in a wide variety of ways in a pharmaceutical establishment, such as, maintenance of quarantine systems for drug components, control of significant steps in manufacturing the dosage form, control of laboratory functions, management of warehousing and distribution activities. Computer systems may control one or more of these phases, either singly or as part of a highly automated integrated complex. 计算机系统以多种多样的方式被用在制药设备中。例如，药品成分检疫系统的维持，制剂过程中重要步骤的控制，实验室功能的控制，仓库和销售情况的管理。计算机系统可以控制这些阶段的一个或多个，单独的或高自动化的完整的系统的一部分。

The purpose of this guide is to provide the field investigator with a framework upon which to build an inspection of drug establishments that utilize computer systems. This document is not intended to spell out how to conduct a CGMP drug inspection or set forth reporting requirements, but rather what aspects of computerized systems to address during such inspections and suggestions on how to address the systems. 这个指南的目的是为了给这个领域的审查者提供一个应用计算机系统的制药设施的验证框架。这个文件不是侧重于清楚说明怎样进行一个CGMP 药品验证，也不是阐明申报报告要求，而是说明计算机处理系统的哪些方面需要在验证过程中验证和怎样对系统进行验证的建议。

This guide discusses some potential problem areas in application of computer systems, provides inspectional guidance, and includes a glossary of terms the investigator should be aware of prior to performing the inspection。Questions and suggestions concerning this guide should be directed to the Manufacturing Standards and Industry Liaison Branch, Division of Drug Quality Compliance (HFN-323)，443-5307; or the Investigations and Engineering Branch，Division of Field Investigations (HFO-520), 443-3276.

这个指南论述了计算机系统应用中的一些潜在的问题，提供验证的指导，并包含审查者在进行验证前应该知道的术语表。和这个指南相关联的问题和建议来自制造标准和生产联络部门，药品质量管理（HFN-323），443-5307；或研究和工程部门，Division of Field Investigations (HFO-520), 443-3276。

II. OVERVIEW 概述

When a computer system is first encountered in a drug establishment, it may be useful for inspectional purposes to begin with a broad overview of the system(s). Determine exactly what processes and functions are under computer control or monitoring and which are not. Computer involvement may be much more limited than it may initially appear。For example, computer application may be limited to control of a sterilization cycle in a single autoclave, or maintenance of distribution records.

当一个计算机系统第一次在药品设备被遇到，从验证的目的说从系统的整体开始入手是有用的。严密地确定什么过程和功能在计算机控制或监视下，哪些没有。计算机牵连可能越来越多被比它最初被看起来。例如，计算机应用可能是有限的在对单独的高压灭菌器内的一个灭菌周期的控制，或销售记录的保管。

For each drug process under computer control determine the general system loop (sensors, central processor, activator)。For example, the general system loop for a steam autoclave under computer control could consist of temperature/pressure sensors connected to a microprocessor that transmits commands to steam/vacuum control valves. 对计算机控制下的每一个药品生产过程，确定通常的系统环路（传感器，处理器，执行器）。例如，计算机控制下的一个蒸汽高压灭菌器的通常的系统环路由连接到微处理器的温度/压力传感器组成，这个微处理器发送控制命令到蒸汽/真空控制阀。

The overview should enable the investigator to identify those computer controlled processes that are most critical to drug product quality.。These are the systems which，of course, merit closer inspection.

这个概述应该使审查者能够确定那些对药品生产质量最关键性的计算机控制过程。当然，这些是更有益于验证的方法。 III. HARDWARE硬件

For each significant computerized system, it may be helpful to prepare or oed schematic drawing of the attendant hardware. The drawing need only include major input devices, output devices, signal converters, central processing unit, distribution systems, significant peripheral devices and how they are linked. Figure 1 is an example of such a drawing. 对于每一个重要的计算机处理系统，准备出专用的硬件示意图是非常有益的。这个图仅需要包括主要的输入设备，输出设备，信号转换器，处理单元，分配系统，重要的外围设备以及它们之间的联系。图1是这样一个图的例子。

Hardware Suppliers.硬件供应商

During the inspection identify the manufacturers/suppliers of important computer hardware，including the make and model designations where possible. Hardware to identify this way includes CPUs, disk/tape devices, CRTs, printers, and signal converters. Proper identification of hardware will enable further follow-up at computer vendors should that be needed.

在验证期间，识别重要的计算机硬件的制造商/供应商，包括每一可能部分的构造和模式。这种方式识别的硬件包括处理器（CPUs），磁盘/磁带设备，显示器（CRTs），打印机和信号转换器。严格的硬件验证将使进一步的继续验证，就需要计算机经销商协助。 A. Types类型

1. Input Devices. Equipment which translates external information into electrical pulses which the computer can understand. Examples are thermocouples, flow meters, load cells, pH meters，pressure gauges, control panels, and operator keyboards.

输入设备。转换外部信息成为计算机能够理解的电子脉冲的装置。例如，热电偶，流量计，压力传感器，酸度计，压力表，控制面板，操作键盘。 Examples of functions are:功能举例：

a) Thermocouple provides temperature input for calculation of F value in a sterilizer. 热电偶为消毒器中的F值的计算提供温度输入。

b) Flow meter provides volume of liquid component going into a mixing tank. 流量计提供加入一个混合罐的液体成分的体积。

c) Operator keyboard used to enter autoclave load pattern number. 操作键盘被用来输入高压灭菌器运行模式号。

2. Output Devices. Equipment which receives electrical pulses from the computer and either causes an action to occur, generally in controlling the manufacturing process, or passively records data. Examples are valves，switches, motors, solenoids, cathode ray tubes (CRTs), printers, and alarms.

输出设备。接收来自计算机的电子脉冲信号，并且触发一个动作产生。通常在控制制造过程或被动的记录数据。例如阀，开关，电动机，电磁铁，显示器(CRTs)，打印机和报警器。 Examples of functions are:功能举例：

a) Solenoid activates the impeller of a mixer. 电磁铁使一个搅拌器的叶轮活动

b) Valve controls the amount of steam delivered to a sterilizer. 阀控制释放到一个消毒器的蒸汽的数量。

c) Printer records significant events during sterilization process. 打印机记录杀菌过程期间的重要事件。

d) Alarm (buzzer, bell, light, etc.) sounds when temperature in a holding tank drops below desired temperature.

当一个储存罐的温度降到低于设定值时，报警器（蜂鸣器，铃，灯等）发出声音。

Most active output devices will be in proximity to the drug processing equipment under control, but not necessarily close to the CPU. Passive output devices, however, may well be remote from the process or the CPU.

大部分有源输出设备都应邻近其控制下的药品生产设备，而不必靠近处理器（CPU）。然而，无源输出设备可以适当的远离生产过程或处理器（CPU）。

3. Signal Converters. Many input and output devices operate by issuing/receiving electrical signals that are in analog form. These analog signals must be converted to digital signals for use by the computer; conversely, digital signals from the computer must be converted into analog signals for use by analog devices. To accomplish this, signal converter devices are used.

信号转换器。众多输入和输出设备接收/发送模拟形式的电信号。为了让计算机使用这些模拟信号必须被转换成为数字信号；反之，来自计算机的数字信号必须被转换成为模拟信号才能被模拟设备使用。为了完成这些转换，就要用到信号转换器。

4. Central Processing Unit (CPU). This is the controller containing the logic circuitry of a computer system that conducts electronic switching. Logic circuits consist of three basic sections - memory, arithmetic, and control. The CPU receives electrical pulses from input devices and can send electrical pulses to output devices. It operates from input or memory instructions.

处理器(CPU)。这是一个控制器，它包含处理电子交换的计算系统的逻辑电路。逻辑电路由三个基本的部分组成―内存，运算器和控制器。处理器接收来自输入设备的电子脉冲，然后送电子脉冲到输出设备。它依靠输入或内存指令工作。 Examples of functions are:功能举例：

a) Programmable controllers can be used for relays, timers and counters. 可编程的控制器能被用做继电器，定时器和计数器。

b) Microprocessors can be used for controlling a steam valve, maintaining pH, etc. They consist of a single integrated circuit on a chip. This is the logic circuit of a microcomputer and microprocessors are often the same as a microcomputer.

微处理器能被用作蒸汽阀的控制，酸碱度的保持等。它们由芯片上一个的完整的电路组成。这是微型计算机的逻辑电路，微处理器的逻辑电路是和微型计算机的逻辑电路一样的。

c) Microcomputers and minicomputers can be used to control a sterilization cycle, keep records, run test programs, perform lab data analysis, etc.

微型计算机和小型计算机能被用来控制一个灭菌循环，保持记录，运行测试程序，进行实验数据分析。

d) Mainframe computers are usually used to coordinate an entire plant, such as environment, production, records, and inventory.

大型计算机通常被用来管理整个一个的车间，例如环境，生产，记录和库存。

The distinction between CPUs is becoming less apparent with miniaturization of parts，CPUs are generally ranked by size from \"large\" mainframes to desk top microcomputers.

处理器之间的差别正在变的越来越小，处理器通常按照尺寸分类，从“巨大”的大型机到桌面处理器。

Distribution System. The interconnection of two or more computers。Also known as distributed processing。Generally, each computer is capable of independent operation but is connected to other computers in order to have a back-up system, to receive operating orders and to relay what is executed by other computers. Typical of such distribution systems is the linkage of smaller or less powerful units to larger or more powerful units. For example, a minicomputer may command and communicate with several

microcomputers. A large CPU may also act as a \"host\" for one or more other CPU's. When such systems are encountered during an inspection, it is important to know the

configuration of the system and exactly what commands and information can be relayed amongst the computers. Figure 2 contains examples of distributed control.

分布式系统。两个或多个计算机的相互连接。作为分布式处理是大家都知道的。通常，每个计算机都能够运行，但被连接到其它计算机为了有一个备用系统，接收操作命令，以及接替其它计算机的工作。典型的分布式系统是联接小的不强大的单元成比较大的或强大的单元。例如，一个小型计算机可以控制

几个微型计算机，可以和几个微型计算机通讯。一个大型处理器也可以为一个或多个其它的处理器的系统担任“主机”。在验证期间，当这种系统被遇到时，知道系统的配置和确定在计算机之间什么样的指令和信息能被传递是重要的。 图2包含分布式描述的例子

Networks are generally extensions of distributed processing. They typically consist of connections between complete computer systems that are geographically distant. Potentially, pharmaceutical companies could have international networks by using modems and satellites.

网络通常是分布式处理的延长。他们一般由全部的地理上的远处的计算机系统间的线路组成。制药公司可以潜在的通过调制解调器和人造卫星接入国际互联网。

6. Peripheral Devices. All computer associated devices external to the CPU can be considered peripheral devices. This includes the previously discussed input and output devices. Many peripheral devices can be both input and output，they are commonly known as I/O devices. These include CRTs, printers, keyboards, disk drives，modems, and tape drives.

外围设备。所有的在外部关联到处理器上的计算机相关的设备都被看作外围设备。这包括先前被讨论的输入和输出设备。许多外围设备同时有输入和输出，它们通常被作为I/O设备。外围设备包括显示器、打印机、键盘、磁盘设备、调制解调器和磁带设备。 B. Key Points 关键点

1. Location. Three potential problems have been identified with location of CPUs and peripheral devices。These are:

位置。和处理器及外围设备的位置相关三个潜在的问题需要被确定。它们是：

a) Hostile Environments. Environmental extremes of temperature, humidity, static，dust, power feed line voltage fluctuations, and electromagnetic interference should be avoided. Such conditions may be common in certain pharmaceutical operations and the

investigator should be alert to locating sensitive hardware in such areas. Environmental safeguards may be necessary to ensure proper operation. There are numerous items on the market (such as line voltage monitors/controllers and anti-static floor mats)

designated to obviate such problems. Physical security is also a consideration in protecting computer hardware from damage; for example, books and bottles of reagents should not be stored on top of microprocessors. Likewise eating, drinking and smoking should be restricted in rooms housing mainframes.

不适宜的环境。温度、湿度、静电、灰尘、输入电压波动和电磁干扰等环境的极度条件应该被避免。这样的环境可能是很普通的在某些制药操作中，审查者避免放置灵敏的硬件在这样的环境中。为了确保正确的操作，环境的安全措施可那能是必须的。市场上有众多的条款（例如，监视器/控制器的线路电压，地板的抗静电性能）来避免这样的问题。在保护计算机硬件远离危险时，设备本身安全也是一个要考虑的问题。例如，试剂的瓶子和书籍不应该放到微处理器的上面。同样地，在放置大型机的房间，吃、喝和吸烟应该被。

b) Excessive Distances between CPU and Peripheral Devices. Excessively long low voltage electrical lines from input devices to the CPU are vulnerable to electromagnetic interference. This may result in inaccurate or distorted input data to the computer. Therefore, peripheral devices located as near to the CPU as practical and the lines should be shielded from such sources of electromagnetic interference as electrical power lines, motors, and fluorescent lighting fixtures. In a particularly \"noisy\" electronic environment this problem might be solved by the use of fiber optic lines to convey digital signals. 处理器和外围设备之间距离太远。输入设备到处理器的电线如果太长，或电压太低是非常遭受电磁干扰的。这可能引起到处理器的输入数据发生错误或变形。因此，外围设备应该按照实际经验距离处理器尽可能的近，来自电磁干扰源如电动力线，电动机和荧光灯的电线应该被屏蔽。在一个特别“嘈杂的”电子环境中，这个问题可以通过应用光线来传输数字信号解决。

c) Proximity of Input Devices to Drug Processing. Input devices which are remote from (out of visual range of) the drug processing equipment are sometimes met with poor employee acceptance.

输入设备应该接近生产设备。输入设备被远离药品生产装置(超出看得见的范围)有时是很难被操作人员接受的。

2. Signal Conversion. Proper analog/digital signal conversion is important if the computer system is to function accurately. Poor signal conversion can cause interface problems. For example, an input sensor may be feeding an accurate analog reading to a signal

converter, but a faulty signal converter may be sending the CPU an inappropriate digital signal.

信号转换。如果让计算机精确的运行，正确的模拟/数字信号转换是重要的，贫乏的信号转换将引起接口问题。例如，一个输入传感器能够将一个精确的模拟量输送到信号转换器，但一个不好的信号转换器可能送一个不相称的数字信号到处理器。

3.I/O Device Operation. The accuracy and performance of these devices are vital to the proper operation of the computer system. Improper inputs from thermocouples, pressure gauges, etc., can compromise the most sophisticated microprocessor controlled sterilizer. These sensors should be systematically calibrated and checked for accurate signal outputs.

I/O设备操作。 这些设备的准确性和可靠性对计算系统地正确运转是至关重要的。来自热电偶，压力表等的重要输入能危及大多数复杂的微处理器控制下的消毒器的安全。这些传感器应该被系统的用精确的输出信号来校准和核对。

4. Command Over-rides. In distributed systems it is important to know how errors and command over-rides at one computer are related to operations at another computer in the system. For example, if each of three interconnected microcomputers runs one of the three sterilizers，can a command entered at one unit inadvertently alter the sterilization cycle of a sterilizer under the control of a different microcomputer on the line? Can output data from one unit be incorrectly processed by another unit? The limits on information and command for distributed system should be clearly established by the firm.

指令中断。在分布式系统，有一点是重要的，就是知道在一台计算机里，多少错误及指令中断是和操作系统中的另一台计算机有关系的。例如，如果三个互连的微型计算机的每一个分别管理三个消毒器中的一个，输入到一个微型计算机中的指令会随意的改变网络中另一个微型计算机控制下的消毒器的灭菌循环吗？一个微型计算机的输出数据会被另一个微型计算机错误处理吗？对于分布式系统，关于信息和命令的应该被公司明确制定。

5. Maintenance. Computer systems usually require a minimum of complex maintenance. Electronic circuit boards, for example, are usually easily replaced and cleaning may be limited to dust removal. Diagnostic software is usually available from the vendor to check computer performance and isolate defective integrated circuits. Maintenance procedures should be stated in the firm's standard operating procedures。 The availability of spare parts and access to qualified service personnel are important to the operation of the maintenance program.

维护。 计算机系统通常仅需要最低的维护成本。例如，电路板通常是容易被代替的。清洁处理仅限于除去灰尘。为了检查计算机性能以及隔离有缺陷的集成电路，诊断软件常常被经销商使用。维护程序应该被规定在公司的标准操作规程（SOP）中。对于有资格的维修人员来说，可用的备件和通道对于维护程序的实施是重要的。

C. Validation of Hardware硬件确认

The suitability of computer hardware for the tasks assigned to pharmaceutical production must be demonstrated through appropriate tests and challenges. The depth and scope of hardware validation will depend upon the complexity of the system and its potential affect on drug quality.

对于分配有药品生产任务的计算机硬件的适合性必须通过适当的测试和挑战性实验来论证。硬件确认的范围和深度将依赖于系统的复杂性和它对药品质量的潜在的影响。

The validation program need not be elaborate but should be sufficient to support a high degree of confidence that the system will consistently do what it is supposed to do. In considering hardware validation the following points should be addressed:

确认方案不需要被详细阐述，但方案应该要足够能使大家对它有一个高度的信心，它能始终如一地做它被期待做的工作。在考虑硬件确认中，下面几点应该被做：

1. Does the capacity of the hardware match its assigned function? For example, in a firm using a computer system to maintain its labeling text, including foreign language labeling, do the CRT and printer have the capacity to write foreign language accent marks? 硬件的能力能够承担它被指派的职责吗？例如，在一个公司用一个计算机系统制作它的标签文本，包括外文标签，那么显示器和打印机有写外文重音符号的能力？

2. Have operational limits been identified and considered in establishing production procedures? For example, a computer's memory and connector input ports might limit the number of thermocouples a computer can monitor. These limits should be identified in the firm's standard operating procedures.

在确定生产方案的时候，操作的性因素是否被确认和考虑？例如，一个计算机的内存和连接器的输入端口可能会一台计算机能够监控的热电偶的数量。这些应该在公司的标准操作规程（SOP）里被确认。

3. Have test conditions simulated \"worst case\" production conditions? A computer may function well under minimal production stress (as in vendor's controlled environment) but falter under high stresses of equipment speed, data input overload or frequent or continuous multi-shift use (and a harsh environment). Therefore, it is insufficient to test computer hardware for proper operation during a one-hour interval, when the system will be called upon in worst-case conditions to run continuously for 14 days at a time. Some firms may test the circuits of a computer by \"feeding\" it electrical signals from a signal simulator. The simulator sends out voltages which are designed to correspond to voltages normally transmitted by input devices. When simulators are connected to the computer, the program should be executed as if the emulated input devices were actually connected. These signal simulators can be useful tools for validation; however, they may not pose worse case conditions and their accuracy in mimicking input device performance should be established. In addition, validation runs should be accomplished on line using actual input devices. Signal simulators can also be used to train employees on computer operations without actually using production equipment.

测试条件模拟了最差的生产条件吗？一台计算机在最小的生产压力下可以很好运行（如同经销商控制的环境），但在设备高速运转，数据输入超负荷及频繁的或连续的轮班使用（和苛刻的环境）情况下，将不能稳定运行。因此，当系统被要求在一个很差的环境里，每次需要连续的运行１４天的工作状况下，以小时为时间间隔期间，来测试计算机硬件能否正确运转是不能够说明问题的。一些公司可能来测试一台计算机的电路，通过“喂”它来自信号发生器的电子信号。信号发生器送出被设计的，和输入设备正常地发送的电压值相应的信号。当信号发生器连接到计算机时，程序应该被执行就像仿真输入设备真正被连接上。这些信号发生器对确认来说是有用的工具。然而，它们不能模拟差的状态，在模拟输入设备性能时，它们的精确性应该被确认。另外，确认运行应该在线用实际的输入设备来完成。信号发生器也能被用来训练没有实际用过生产设备，而要在计算机上操作的职工。

4. Have hardware tests been repeated enough times to assure a reasonable measure of reproducibility and consistency? In general, at least three test runs should be made to cover different operating conditions. If test results are widely divergent they may indicate an out of control state.

为了确保合理的测量的再现性和一致性，硬件测试应该被重复足够的次数？通常，为了适用不同的操作条件，至少三个运行测试应该被做。如果测试结果是离散的，可能预示一个失控的状态。 5. Has the validation program been thoroughly documented? Documentation should include a validation protocol and test results which are specific and meaningful in relation to the attribute being tested. For example, if a printer's reliability is being tested it would be insuess the results merely as \"passes,\" in the absence of other qualifying data such as printing speeds, duration of printing, and the number of input feeds to the printing devices.

确认方案已经彻底地形成文件了吗？文件应该包括确认草案，包括和被测试属性相关联的详细而精确的有意义的测试结果。例如，如果一个打印机的可靠性被测试，在不考虑其它有资格的数据，例如打印速度，打印持续时间，和输入到打印设备的数据量的情况下，其结果只能算作“及格”。

6. Are systems in place to initiate revalidation when significant changes are made? Revalidation is indicated, for example, when a major piece of equipment such a circuit board or an entire CPU is replaced. In some instances identical hardware replacements may adequately be tested by the use of diagnostic programs available from the vendor. In other cases, as when different models of hardware are introduced, more extensive testing under worst-case production conditions，is indicated.

当重要的改造被做时，系统进行重新确认了吗？例如，当一个主要的部件如电路板或整个处理器被替换时，重新确认是需要的。在一些情况下，同一硬件替代品可能通过应用来自卖主的可利用诊断程序充分测试。至于其它情形，当不同模式的硬件被引入时，更广泛的测试需要在最差生产环境下做。 Much of the hardware validation may be performed by the computer vendor. However, the ultimate responsibility for suitability of equipment used in drug processing rests with the pharmaceutical manufacturer. Hardware validation data and protocols should be kept at the drug manufacturer's facility. When validation information is produced by an outside firm, such as the computer vendor，the records maintained by the drug establishment

need not be all inclusive of voluminous test data; however，such records should be reasonably complete (including general results and protocols) to allow the drug

manufacturer to assess the adequacy of the validation. A mere certification of suitability from the vendor, for example, is inadequate.

大部分的硬件确认可以由计算机经销商来做。然而，被用在药品生产的装置的合适性的最终的责任归于药品制造商。硬件确认数据和方案应该被保存在药品生产商的现场。当确认信息来自外面的公司时，例如计算机销售商，被药品公司保存的数据不需要包含所有的测试数据。然而让药品厂商评估确认充分性的这些记录（包括一般的结果和协议）应该相当的完善。例如，一个仅仅来自计算机经销商的适用性的证明是不充分的。 IV. SOFTWARE软件

Software is the term used to describe the total set of programs used by a computer. These programs exist at different language levels, generally the higher the level，the closer the text is to human language. These levels are set forth below. During the inspection identify key computer programs used by the firm. Of particular importance are those programs which control and document dosage form production and laboratory testing. Usually a firm can readily list the names of such programs on a CRT display or in hard copy. Such a list is sometimes called a menu or main menu.

软件是用来描述被计算机使用的整套程序的术语。这些程序存在不同的语言级别，通常级别越高，文本越接近人类语言。这些级别向下兼容。在验证期间，确认公司使用的关键的计算机程序。其中特别重要的是那些控制并证明产品剂量形式和实验室测试的程序。通常，一个公司能很容易列出这样程序的名字显示在显示器上显示或打印出来。这样一个目录有时被称作菜单或主菜单。 A. Levels分级

1. Machine Language. This loaf coded instructions, represented by binary numbers, which are executed directly by the computer.

机器语言。这种编码的指令，用二进制数表示，被计算机直接执行。

2. Assembly Language. Instructions are represented by alphanumeric abbreviations. These programs must be converted into machine language, sometimes called \"object programs,\" before they can be executed. Programs which translate assembly programs to object programs are called assemblers. Different computers have different assembly languages. Computer manufacturers usually provide the assembler program.

汇编语言。指令用包含文字和数字的缩写表示。这些程序在执行前，必须被转换成为机器语言，有时被称作“目标程序”。将汇编程序翻译成目标程序的程序被称作编译程序。不同的计算机有不同的汇编代码。计算机厂商通常提供编译程序。

3. High Level Language. This language is characterized by a vocabulary of English words and mathematical symbols. These are source programs which must be translated by a compiler or interpreter into an object program. High level languages generally

operate the same on any computer which accepts the language although there may be different versions of the same language. Examples are FORTRAN, BASIC, and COBOL. 高级语言。这种语言通过英语词汇和数学符号表示。源代码程序必须通过编译器或解释程序翻译成为目标程序。高级语言通常运行在接受这种语言的任何计算机上，尽管同一种语言有不同的版本。例如，FORTRAN，BASIC和COBOL。

4. Application Language. This is generally based on a high level language but modified for a specific industry application and uses the vocabulary of that industry. Examples are AUTRAN (Control Data Corporation) and Foxboro Process Basic.

应用语言。 这种语言通常基于一个高级语言，但是针对特殊的工业应用被改进，它被用这种工业的词汇表示。例如，AUTRAN（Control Data Corporation）和Foxboro Process Basic。 B. Software Identification软件验证

For the key computer programs used by a firm, the following items should be identified:

对公司使用的关键的计算机程序，下列项目应该被确认：

1. Language. High level or application name should be determined (or machine or assembly language).

语言。 高级语言或应用语言的名字应该被确定（或机器、汇编语言）。

2. Name. Programs are usually named with some relationship to what they do, i.e. Production Initiation, Batch History Transfer or Alarms.

名字。 软件通常用一些和它们用途相关联的词汇命名。例如：生产启动，传递或报警的批历史记录

3. Function. Determine what the purpose of the program is, i.e., start production, record and print alarms, or calculate F. 功能。 决定程序用途是什么？

4. Input. Determine inputs, such as thermocouple signals, timer, or analytical test results.

输入。 决定输入，如热电偶信号，定时器或分析的测试结果。

5. Output. Determine what outputs the program generates. These may be a form of mechanical action (valve actuation) or recorded data (generation of batch records). 输出。 决定程序产生什么样的输出。可以有机械运行（阀的动作）形态或被记录的数据（产生一批记录）。

6. Fixed Setpoint. This is the desired value of a process variable which cannot be changed by the operator during execution. Determine major fixed setpoints, such as desired time/temperature curve，desired pH, etc. Time may also be used as a set point to stop the process to allow the operator to interact with the processing.

固定的监测点。这是在执行期间不能被操作者改变的理想的过程变量值。确定主要的监测点，例如理想的时间/温度曲线，理想的酸碱度等。时间也可以被用作一个监测点，为了停止一个过程，允许操作者人为干预过程。

7. Variable Set point. This is the desired value of a process variable which may change from run to run and must usually be entered by the operator. For example, entering one of several sterilizer load patterns into a sterilization computer process.

变化的监测点。这是在每次运行前可以被改变的理想的过程变量值，通常由操作工输入。例如，将几个消毒模式中的一个输入到杀菌的计算机程序。

8. Edits. A program may be written in such a manner as to reject or alter certain input or output information which does not conform to some pre-determined criterion or otherwise fall within certain pre-established limits. This is an edit and it can be a useful way of minimizing errors; for example, if a certain piece of input data must consist of a four character number, program edits can be used to reject erroneous entry of a five character number or four characters comprised of both numbers and letters. On the other hand, edits can also be used to falsify information and give the erroneous impression that a process is under control; for example, a program output edit may add a spurious \"correction\" factor to F values which fall outside of the pre-established limits, thus turning an unacceptable value into an ue. It is, therefore, important to attempt to identify such significant program edits during the inspection, whenever possible. Sometimes such edits can manifest themselves in unusually consistent input/output information.

编辑。 一个程序可以用这样一种方式被写，为了丢弃或改变某些不符合某一预定规范的或其他方面不在设定限度内的输入或输出信息。这是一个编辑工作，而且它是将错误减少到最少的一个有用的方式。例如，如果某一条输入数据必须由四个字节的数字组成，程序编辑能被用来丢弃五个字节的数字或虽然由四个字节组成，但是含有数字和字母的错误的输入。另一方面，编辑也能被用来伪造信息和给被控制下的过程一个错误的感觉。例如，一个程序输出编辑可以加一个伪造的修正因数到不在预先设定限度的Ｆ值。这样就可以把一个不合格的值变成一个合格的。因此，在验证期间的任何可能时间，尝试确定这样一个有意义的程序编辑是非常重要的。

9. Input manipulation. Determine how a program is set up to handle input data. For example, determine what equations are used as the basis for calculations in a program. When a process is under computer control determine, in simplified form such as a flow chart, how input is handled to accomplish the various steps in the process. This does not mean that a copy of the computer program itself needs to be reviewed. However, before computerized control can be applied to a pharmaceutical process there usually needs to be some source document, written in English, setting forth in logical steps what needs to be done; it would be useful to review such a document in evaluating the adequacy of conversion from manual to computerized processing.

输入处理。确定一个程序怎样处理输入数据。例如，确定在一个程序里，什么样的方程式被用作计算的依据。当一个计算机控制下的过程，用一个简化的形式例如流程图确定时，为了完成这个过程中的

各种各样的步骤，输入应该被怎样处理？这不是意谓着程序自身的复制。然而一个计算机过程能被用到药品生产前，通常需要一些用英文写的源文件，用逻辑步骤来阐述什么需要被做。在评估从手动到计算机处理转换的充分性时，考察这样一个文件将是有用的。

10. Program Over-rides. A program may be such that the sequence of program events or program edits can be over-ridden by the operator. For example, a process controlling program may cause a mixer to stop when the mixer's contents reach a predetermined temperature. The program may prevent the mixer from resuming activity until the temperature has dropped back to the established point. However, the same program may allow an operator to over-ride the stop and reactivate the mixer even at a temperature which exceeds the program limit. It is therefore important to know what over-rides are allowed, and if they conflict with the firm's SOP.

程序中断。 一个程序可以是这样的，程序事件的顺序和程序的编辑能被操作工中断。例如，当混合物的温度达到预定温度时，一个过程控制程序可以让一个搅拌器停止，这个程序可以阻止搅拌器恢复动作，直到温度降到设定点。然而，同一个程序可以允许操作工中断这个停止，重新启动搅拌器甚至温度超过程序限度时。因此，知道什么样的中断被允许，它们是否和公司的ＳＯＰ冲突是重要的。 C. Key Points关键点

1. Software Development. During the inspection determine if the computer programs used by the firm have been purchased as \"canned\" from outside vendors, developed within the firm, prepared on a customized basis by a software producer, or some combination of these sourams are highly specialized and may be licensed to pharmaceutical

establishments. If the programs used by the firm are purchased or developed by outside vendors determine which firms prepared the programs.

软件升级。在验证期间，确认是否公司用的计算机程序是作为“固定”从外面的经销商那里购买的，在公司内部升级，被软件制作者以定制的方式编制或者这些的组合是高度专业化的并且可以被制药公司授权。如果公司用的程序是购买的或被外面的经销商升级，确认哪个公司编制这些程序。

In some cases \"canned\" or customized programs may contain segments (such as complex algorithms)which are proprietary to their authors and which cannot normally be readily retrieved in program code without executing complex code breaking schemes. In these cases the buyer must accept on faith that the software will perform properly. If the drug manufacturer is using such a program to control or monitor a significant process, determine what steps the firm has taken to assure itself that such program blind spots do not compromise the program performance.

在一些情况下，“固定”或定制的程序可以包含一些程序段（例如运算函数），这些程序段被它们的作者所有的，通常不执行复杂的中断配置的代码，就不能容易的在程序代码中找回。在这些情况下，买主必须满怀信心地接受这些软件将正确执行。如果药品厂商用这样一个程序控制或监视一个重要的过程，确定公司将采取什么样的步骤来确保程序自身的盲点不会危及到它的性能。

Where drug firms develop their own application programs, review the firm's

documentation of the approval process. This approval process should be addressed in the

firm's SOP. It may be useful to review the firm's source (English) documents which formed the basis of the programs.

药品公司升级他们自己的应用程序的地方，检查公司被批准的过程文件。这些被批准的过程应该被写在公司的ＳＯＰ上。检查形成程序的根据的公司的源（英语）文件是有用的。

2. Software Security. Determine how the firm prevents unauthorized program changes and how data are secure from alteration, inadvertent erasures, or loss (21 CFR 211.68). Some computers can only be operated in a programming mode when two keys are used to unlock an appropriate device. When this security method is used, determine how use of keys is restricted. Another way of achieving program security is the use of ROM (read only memory), PROM (programmable read only memory), or EPROM (erasable programmable read only memory) modules within the computer to \"permanently\" store programs. Usually, specialized equipment separate from the computer is needed to change an EPROM or establish a program in PROM so that changes would not be made by the operator. A program in EPROM is erase the module (which has a quartz window) to ultraviolet light. In these cases a program is secure to the extent it can't be over-ridden by the operator. Determine who in the firm has the ability and/or is authorized to write, alter or have access to programs. The firm's security procedures should be in writing. Security should also extend to devices used to store programs, such as tapes, disks and magnetic stripe cards. Determine if accountability is maintained for these devices and if access to them is limited. For instance, magnetic stripe cards containing a program to run a sterilization cycle may be kept in a locked cabinet and issued to operators on a charge-out basis with return of the card immediately after it is used.

软件安全。确定公司怎样阻止未被允许的程序改变，以及数据怎样避免变更，意外的删除或丢失（21 CFR 211.68）。一些计算机只能在程序模式被启动，当两个钥匙被用来机开锁定的设备。当安全方法被用时，确定钥匙的使用怎样被限定。实现程序安全的另一个方法是为了“永久地”存储程序，在计算机内部使用ROM，PROM或EPROM模块。通常，和计算机分离的专用设备被需要为了改变EPROM或在PROM里面设置一个程序，这样操作员就不能对程序做改变。在EPROM里的程序可以用紫外线擦除。在这些情况下，程序不能被操作员修改是安全的。确定公司里谁有能力和/或被授权对程序编写，改变或存取。公司的安全程序应该被编写。安全也应该延伸到被用来存储程序的设备，诸如磁带、磁盘和磁条卡片。确定是否，并且是否存储它们被。例如，包含一个运行杀菌循环的程序的磁条卡片可以被保存在一个锁定的橱柜里。

D. Validation of Software软件确认

It is vital that a firm have assurance that computer programs, especially those that control manufacturing processing, will consistently perform as they are supposed to within pre-established operational limits. Determine who conducted software validation and how key programs were tested. In considering software validation the following points should be addressed:

有一点时至关重要的，就是公司能够确保它的计算机程序，特别是那些控制生产过程的计算机程序，能够在预先设定的操作限度内，始终如一地执行它们被期待的职能。确定谁管理软件的确认和多少关键的软件被测试。在考虑软件确认时，下面几点应该被做：

1. Does the program match the assigned operational function? For example, if a program is assigned to generate batch records then it should account for the maximum number of different lots of each component that might be used in the formulation. Consider what might happen when three lots of a component are used with a program designed to record lot designations and quantities for up to two different lots of each component. The first lot may be accurately recorded, but the next two lots might be recorded as a single quantity having the second lot designation; the resultant computer generated record therefore would fail to show the use of three different lots and the quantities of each of the second and third lots going into the mixture.

程序和它被指定的操作功能一致吗？例如，如果一个程序被指定产生批记录，那么它应该说明可以在配方里被用的不同批的每个成分的最大数量。考虑什么可以发生，当三批产品的一个成分，被用一个程序来设计记录批名称和数量对正在做的两个不同批的每个成分。第一批可以被精确地记录，但下面两批可以被记录作为单一数量单位

2. Have test conditions simulated \"worst case\" production limits? A program should be tested, for example, under the most challenging conditions of process speed, data volume and frequency. Date should be considered in this aspect of validation. For example, the number of characters allowed for a lot number should be large enough to accommodate the longest lot number system that will be used.

测试环境模拟的是最差的生产限度吗？例如，一个程序应该在生产速度，数据量和频率都为最富挑战性的状态下被测试。在确认下列方面的问题时，数据应该被考虑。例如，

3. Have tests been repeated enough times to assure consistent reliable results? Divergent results from replicate data entries may signify a program bug. In general, at least three separate runs should be made.

为了确保结果的一致性和可靠性，测试被重复足够的次数了吗？和大部分数据分歧的结果可能意味着一个程序错误。通常，至少要做三次的运行。

4. Has the software validation been thoroughly documented? Documentation should include a testing protocol and test results which are meaningful and specific to the attribute being tested; individuals who reviewed and approved the validation should be identified in the documentation.

软件确认被完全文件化了吗？文件应该包括测试草案和对被测试的品质有意义的，详细而精确的测试结果。进行和批准这个确认的人应该在文件中确定。

5. Are systems in place to initiate revalidation when program changes are made? If process parameters such as time/temperature, sequence of program steps, or data editing/handling are changed then revalidation is indicated.

当程序发生改变时，替代系统的重新确认被做了吗？如果过程参数，诸如时间/温度，程序步骤或者数据编辑/处理被改变时，就需要重新确认。

Although much of the software validation may be accomplished by outside firms, such as computer or software vendors, the ultimate responsibility for program suitability rests with the pharmaceutical manufacturer. Records of software validation should be

maintained by the drug establishment, although when conducted by outside experts such records need not be voluminous but rather complete enough (including protocols and general results) to allow the drug manufacturer to assess the adequacy of the validation. Mere vendor certification of software suitability is inadequate. Signal simulators many be used in software validation. These are discussed in point No. 3 of Validation of Hardware. 尽管大部分软件确认可以被外面的公司完成，例如，计算机或软件的经销商，但是程序适用的最终责任还是归于药品生产商。软件确认记录应该被药品公司保存。当一些记录被外面的专家做时，这样的记录不需要太全面，只要使药品厂商能够评定确认的充分性即可。软件的适用性仅仅被经销商证明是不能说明问题的。

V. COMPUTERIZED OPERATIONS计算机化操作 A. Networks网络

If the firm is on a computer network it is important to know: (1) what output, such as batch production records, is sent to other parts of the network; (2) what kinds of input (instructions, programs) are received; (3) the identity and location for establishments which interact with the firm; (4) the extent and nature of monitoring and controlling activities exercised by remote on-net establishments; and (5) what security measures are used to prevent unauthorized entry into the network and possible drug process sabotage. 如果公司有计算机网络，那么知道下面几点是相当重要的：（1）什么输出，例如批生产记录，被送到网络的其它部分；（2）什么输入（指令，程序）被接收；（3）公司相互作用的设备的一致性和放置位置；（4）远程的网络上的设备行使监控活动的范围和类别；（5）为了防止未被授权的输入进入这个网络，防止对药品过程破坏，什么样的安全措施被采用。

It is possible under a computer network for manufacturing operations conducted in one part of the country to be documented in batch records on a real-time basis in some other part of the country. Such records must be immediately retrievable from the computer network at the establishment where the activity took place (21 CFR 211.180). 它是可能的，对于有计算机网络的制造企业，在国家的一个部分操作管理被用基于国家一些其它地方的实时时间的批记录形成文件。这样的记录必须是可以通过计算机网络立即获取的在活动发生的地方的设备(21 CFR 211.180)。

B. Manual Back-up Systems手动备份系统

Functions controlled by computer systems can generally also be controlled by parallel manual back-up systems. During the inspection determine what functions can be manually controlled and identify manual back-up devices. Process controls are particularly

important. Determine the interaction of manual and computerized process controls and the degree to which manual intervention can over-ride or defeat the computerized process. The firm's SOP should describe what manual over-rides are allowed, who may execute them, how and under what circumstances. Determine if and how manual interventions are documented; a separate log may be kept of such interventions. The computer system may be such that it detects, reacts to and automatically records manual interventions and this should be addressed during the inspection.

由计算机系统控制的功能通常也能被类似的手动的备份系统控制。在验证期间确定什么样的功能能被用手控制和确定手动的备份设备。过程控制是特别重要的。确定手动的和自动的过程控制的交互作用，确定手动干涉使自动处理中断或失效的程度。公司的标准操作规程（SOP）应该记述什么样的手动中断是被允许的，谁，在怎样的情况下可以执行它们。确定手动的干涉是否以及怎样形成文件。一个个别的日志可以保存这样的中断。一个计算机系统可以向这样的探测，启动并自动记录手动的干涉。这应该在验证期间被处理

C. Input/Output Checks 输入/输出检查

Section 211.68 of the CGMP regulations requires that input to and output from the computer system be checked for accuracy. While this does not mean that every bit of input and output need be checked it does mean that checking must be sufficient to provide a high degree of assurance that input and output are, in fact, accurate. In this regard the ome reasonable judgment as to the extent and frequency of checking based upon a variety of factors such as the complexity of the computer systems. The right kinds of input edits, for example, could mitigate the need for extensive checks.

CGMP规则的Section 211.68部分要求来自计算机系统的输入和输出的精确性要被校验。而这不意味着输入和输出的每一位都需要被校验。实际上，它仅意味着校验必须足够对输入和输出的精确性提供一个高度的保证。在这点上，就检查深度和频率的合理的判断，要依据一个变化的因素，诸如计算机系统的复杂性。例如，输入编辑的种类，减轻广泛的检查的需要。

During the inspection determine the degree and nature of input/output checks and the use of edits and other built-in audits.

验证期间，确定输入/输出检查种类和深度，编辑的应用以及其它内建的审核。

Input/output error handling has been a problem in computer systems. Determine the firm's error handling procedures including documentation, error verification, correction verification, and allowed error over-rides including documentation of over-rides.

在计算机系统中，输入/输出错误处理是一个问题。确定公司的错误处理程序，包括文件、错误确认，修正确认，和被允许的错误中断包括中断文件。

As an illustration of inadequate input/output checks and error handling consider the situation of a firm which uses a computer system to maintain and revise labeling text. Master labeling is recorded on a disk and when a change is to be made the operator calls

up a copy of the text from the master disk onto a CRT. The copy is then revised at the CRT, printed on paper and electronically printed onto another disk for storage until the paper copy is proofread and approved; once the paper copy is approved, the text on the temporary storage disk is transferred to the master disk replacing the previous text. As an example, the operator calls up a label to change the directions for use section, correctly makes the change but accidentally erases the quantity of content statement that read 100 ml. The operator \"corrects\" this error by re-entering what was believed to be the correct statement but what, in fact, was \"150 ml.\" The proof-readers do not detect this error because their standard operating procedure is to proof only those portions of the labeling-in these case directions for use-which were supposed to be changed (a case of inadequate output check). In addition, the operator does not document the error or the \"correction\" and the \"correction\" is not verified. This would probably result product. Section 211.68 of the CGMP regulations also requires maintenance of accurate back-up files of input data which are secure from alteration, loss or inadvertent erasure. These back-up files need not be on paper, however. They may, for instance, consist of duplicate tapes, disks or microfilm. During the inspection determine if the firm has such a back-up system, the form of such a system, and how it is protected. If a back up file is printed on thermal paper note if older files have faded. (It has been reported that the printing on thermal paper has a tendency to fade with time.)

作为一个不适当的输入/输出的实例，对于一个用计算机系统维持并修订标签文本的公司，核对和错误处理要考虑这种情形。主要的标签被记录到磁盘上，当一个改变将被做时，操作员从主磁盘调用这个文本的拷贝到显示器上。然后，这个拷贝被在显示器上修改，被打印到纸上，电子输出到另一个存储盘上直到这个纸拷贝被校对和认可；一旦这个纸拷贝被批准，临时存储盘上的文本被转移到主存储盘替代先前的文本。例如，操作员调用一个标签为了改变使用部分的说明。他正确的进行了这个改变，但是意外地擦除了标记100mL的声明容量数量。操作员“改正”这个错误通过重新加入被认为是正确的声明，但实际上是“150mL”。校对者不能察觉这个错误，因为他们的标准操作规程将仅检验标签的那些部分―被改变的使用说明部分。另外，操作员不对错误或“改正”形成文件，那么“改正”不能被检验。这或许将影响产品。CGMP规范的Section 211.68也要求对于输入数据要保持正确的备份的文件，免受变更、遗失或无意中的擦除的侵害。然而，这些备份文件不需要输出到纸上。例如，他们可以由复制磁带，磁盘或缩影胶片组成。在检查期间，确定公司是否有这样一个备份系统，这样一个系统的形式，以及它怎样被保护。如果一个备份文件被打印在热敏纸上，是否以前的文件已经褪色。（打印到热敏上纸的文件的褪色时间应该被报告。）

D. Process Documentation过程文件

Most computer systems are capable of generating accurate and detailed

documentation of the drug process under computer control. What is important is that records within the scope of the CGMP regulations, which happen to be in computerized form, do contain all of the information required. For example, if batch production records are generated by computer determine if they contain all of the information required to be in batch records.

大部分的计算机系统有能力产生正确的并且详细的计算机控制下的药品生产的文件。重要的是那些用计算机处理形式的CGMP规则范围内的记录确实包含所有的被要求的信息。例如，是否批生产记录由计算机产生，确定是否在批记录内包含所有被要求的信息。

E. Monitoring of Computerized Operations计算机处理系统的监视

Determine the degree to which the firm's personnel monitor computerized operations. Is such monitoring continuous or periodic? What functions are monitored? For example, a firm's computer system may be used to maintain the pH in a reaction vessel, but if the firm does not sufficiently monitor the system they may fail to detect a hardware problem that could allow the pH to be out of tolerance. During the inspection, where possible, spot-check computer operations such as:

确定公司员工监视计算机处理操作的程度。这样的监视是连续的或者周期的吗？什么活动被监视？例如，一个公司的计算机系统可以被用来维持一个反应器中的酸碱度，但如果公司不能充分的监视这个系统，他们可能未能发现一个允许酸碱度超出允许容量范围外的硬件问题。在验证期间，在任何可能的地方抽查计算机运行，例如：

1. Calculations; compare manual calculations of input data with the automated calculations or ask the firm to process a given set of input values and compare automated results against known results.

计算； 比较对输入数据的手工计算和自动计算或要求公司处理一批特定的输入值，并且比较自动化的结果和已知结果。

2. Input recording; compare sensor indications with what the computer indicates, for example. As mentioned previously, some analog signals may be incorrectly converted to digital signals and built-in programming edits may alter input data. For example, a thermocouple indicating 80øC may read out on a CRT as 100øC or any other temperature if the signal con malfunctioning.

输入记录；比较传感器指示和计算机显示，例如，象以前说到的一样，一些模拟信号可能被不正确的转换成为数字信号，并且内置的程序编辑可以改变输入数据。例如，如果有信号故障，一个指示温度为80oC热电偶可以在显示器上显示为100oC或其它的温度。

3. Component quarantine control; for example, check the actual warehouse location of a particular lot against its location as reported by computer. If the computer indicates that a particular lot has passed a certain number of laboratory tests then the laboratory records may be checked to confirm the computer information.

组成隔离控制；例如，核对一个特殊批次实际的在仓库位置和它被计算机报告的位置。如果计算机显示一个特殊批次已经通过一定数目的实验室测试，那么为了确认计算机信息，实验室记录可能被检查。 4. Timekeeping; where computers are reporting events and controlling a process in real time, spot-check the time accuracy against a separate time piece; accurate timekeeping is especially important where time is a determinative or limiting factor in a

process such as sterilization. It should be noted that some computer systems run on a 12-hour clock whereas others run on a 24-hour clock.

时间记录；计算机正在实时地报告事件和控制一个过程的地方，抽查时间的精确性与单独的时钟相比。在一个时间是一个限定或因素的地方，精确的时间记录是特别重要的在这些过程，诸如杀菌过程。这点是应该被注意的，某些计算机系统按照12小时制时钟运行，但是其它运行按照24小时制时钟运行。

5. Automated cleaning in-place; determine the procedure used，how the firm assures adequacy of cleaning, and residue elimination.

在线自动清洗。确定被用的程序以及公司怎样保证清洁效果和残液排除。

6. Tailings accountability; where batches are produced back to back on a continuous basis under computer control are batch tailings accounted for in subsequent handling and formulation? For example, at the conclusion of a run the computer's memory may be downloaded and the controlling program reset. At an initial step the computer may call for a programmed quantity of material to be added to a hopper; the amount to be added can be based upon the tare weight of an empty hopper. However, if the hopper is not, in fact, empty but contains tailings of a prior run the result may be a hopper with more material than called for in the batch formulation; thus, there may be errors of yield reconciliation or batch formulation. During the inspection determine what limits if any the firm places on tailings.

尾料说明； 在一个批次被连续地在计算机控制下生产的地方，尾料在后来的处理和配制里被计算了吗？例如，在一个运行结束，计算机的内存可以被下载，并且控制程序复位。在最初的一步，计算机可能要求一个可程序化数量对被加到一个漏斗的原料；被加入的数量可以是基于一个空漏斗的皮重。然而，如果漏斗，事实上，不空，而是包含前次运行的尾料。结果可能是漏斗具有比要求的根据批配方计算出来的数量多的原料，从而可能有和产量或这批配制不相符的错误。验证期间，确定如果公司放置尾料，有什么样的。 F. Alarms报警

A typical computer system er of built-in alarms to alert personnel to some out-of-limits situation or malfunction. Determine what functions are linked to alarms. For example, alarms may be linked to power supply devices, feedback signals to confirm execution of commands, and pharmaceutical process conditions such as empty or overflowing tanks. Determine the alarm thresholds for critical process conditions and whether or not such thresholds can be changed by the operator. For example, if the temperature of water in water for injection system is linked to an alarm which sounds when the temperature drops below 80øC, can the operator change the threshold to 75øC?

一个典型的计算机系统有内置报警器来提醒职工随时注意限度外的情形或故障。确定什么功能被连接到报警器。例如，报警器可以被连接到电力供应设备，确认命令执行的反馈信号以及制药过程的环境，诸如空或溢出的罐。确定报警器启动的临界条件和这样的启动是否能被操作员改变。例如，注射用水系统中如果水的温度连接到一个温度低于80øC时报警的报警器，操作员能够改变启动条件到75øC吗？

Determine how the firm responds when an alarm is activated. This should be covered in the firm's standard operating procedures.

确定当一个发生报警发生时，公司应该怎样反应。这点应该在公司的标准操作规程里说明。 Determine the types of alarms (lights, buzzers, whistles, etc.) and how the firm assures their proper performance. Are they tested periodically and equipped with in-line monitoring lights to show they are ready?

确定报警类型（灯、蜂鸣器，鸣笛，登）和公司怎样确保它们的固有的性能。它们被周期性的测试了吗？并用装备的内嵌的监视灯显示它们的准备状况了吗？

Because an activated alarm may signal a significant out of control situation it is important that such alarm activations are documented. Determine how alarm soundings are documented-in batch records, in separate logs or automatic electronic recording, for instance. Can all alarm conditions be displayed simultaneously or must they be displayed and responded to consecutively? If an employee is monitoring a CRT display covering one phase of the operation will that display alert the employee to an alarm condition at a different phase? If so, how?

一个激活的报警器可以用信号通知一个重要的失控情形，所以这样的报警活动被文件化是相当重要的。确定报警信息怎样文件化，例如，用批记录，用的日志，或者自动的电子记录。所有的报警条件能被同时显示，或者它们必须被连续的显示和响应吗？如果一个职工正在监视一个覆盖操作的一个阶段的显示器的显示，那么不同阶段的提醒职工一个报警的情况可以被显示吗？如果这样，该怎样做？ G. Shutdown Recovery停止恢复

How a computer controlled process is handled in the event of computer shutdown (e.g. power failure) is significant and can pose a problem。 Shutdown recovery procedures are not uniform in the industry. Some systems, for example, must be restarted from the initial step in the process sequence and memory of what has transpired is lost. Other systems have safeguards whereby memory is retained and the process is resumed at the point Determine the disposition of the computer's memory content (program and data) upon computer shutdown.

一个计算机控制的过程在计算机停止时（例如，掉电）怎样被处理时一个重要的问题，也是一个难题。在工厂里，停止恢复程序不是一成不变的。例如，一些系统必须被从初始化步骤重新开始。其它的系统 Determine the firm's shutdown recovery procedure and whether or not, in the event of computer failure, the process is brought into a \"safe\" condition to protect the product. Determine such safeguards and how they are implemented. Where is the point of restart in the cycle--at the initial step, a random step or the point of shutdown? Look for the inappropriate duplication of steps in the resumption of the process.

确定公司的停止恢复程序，在计算机故障时，过程被带入一个“安全的”环境来保护产品。确定这样的安全措施以及怎样执行它们。循环的重新开始点在哪里，在起始步骤，在任意步骤或停止点？在过程恢复中，寻找不相称的步骤副本。

The time it takes to resume a computerized process or switch to manual processing can be critical, especially where failure to maintain process conditions for a set time (e.g. pH control for antibiotic fermentation) compromises product integrity。Therefore, note recovery time for delay-sensitive processes and investigate instances where excessive delays compromise product quality or where established time limits (21 CFR 211.111) are exceeded.

重新开始一个计算机处理的过程或向手动处理转换所花费的时间，是需要被鉴定的，特别是那些在设定时间过程状态保持失败将危机产品完整性的地方（例如，抗生素发酵的酸碱度控制）。因此，对于延时敏感的过程要记录恢复时间，并且要研究这些过分的延时会危及产品质量或超过已制定的时间限度(21 CFR 211.111)的地方。

Many systems have the ability to be run manually in the event of computer shutdown. It is important that such back-up manual systems provide adequate process control and documentation. Determine if back-up manual controls (valves, gates, etc.) are sufficient to operate the process and if employees are familiar with their operation. Records of manual operations may be less detailed, incomplete, and prone to error, compared to computerized documentation, especially when they are seldom exercised. Therefore, determine how manual operations are documented and if the information recorded manually conforms with CGMP requirements.

许多系统有能力在计算机停止事件时手动的运行。提供足够的过程控制和文件的备用的手动系统是重要的。确定备用的手动控制（阀，闸等）是否足够控制这个过程，职工是否熟悉它们的操作。和计算机处理的文件相比，手动操作的记录是不详细的，不完全的，有错误倾向的，特别是当它们很少被使用时。因此，确定手动操作怎样被文件化，手工记录的信息是否符合CGMP的要求。

VI．CGMP GUIDANCE CGMP指导

A. Hardware硬件

In general, the hardware of a computer system is considered to be equipment within the meaning of the CGMP regulations. Therefore those sections of the regulations that address equipment apply to hardware.

通常，计算机系统的硬件被认为是符合CGMP规范的内涵的设备。因此针对设备的那些规范的章节适用于硬件。

For example, the following apply:例如，下面的应用：

1. 21 CFR 211.63 repment be suitably located to facilitate operations for the equipment's intended use.

21 CFR 211.63要求设备合适地放置，为了使对设备的指定用途便于操作。 2. 21 CFR 211.67 requires a maintenance program for equipment. 21 CFR 211.67要求一个适用于设备的维护方案。

3. 21 CFR 211.68(a) states that computers may be used and requires a calibration program.

21 CFR 211.68(a)规定计算机可以被使用，并要求一个校验程序。 B. Software软件

In general, software is regarded as records or standard operating procedures (instructions) within the meaning of the CGMP regulations and the corresponding sections of the CGMP regulations apply, for example:

通常，软件被看作是符合CGMP规范的内涵的记录或标准操作程序，CGMP规范涉及的相应章节，例如：

1. Record Controls. 21 CFR 211.68(b) requires programs to ensure accuracy and security of computer inputs, outputs, and data.

记录控制。21 CFR 211.68(b)要求编制程序来确保计算机输入、输出和数据的准确度和安全性。 2. Record Access. 21 CFR 211.180(c) states that records required by the regulations shall be available as part of an authorized inspection at the establishment for inspection and are subject to reproduction. Computer records retrievable from a remote location are acceptable.

记录存取。21 CFR 211.180(c)规定被规范要求的记录作为一个被认可的验证的部分，将是可用的，并且是可以再现的。远程获取的计算机记录是可以接受的。

In considering the copying of electronic records however, the act of copying must be reasonable, as the word reasonable is used in the FD&C Act to limit how we may conduct inspections. In some cases it may be reasonable to copy a disk or tape whereas in other cases it might not, particularly where we would have to physically remove the disk or tape from the establishment in order to copy it. (Consider the analogy of removing an entire file cabinet so that we can copy five pieces of paper.) We believe that, rather than copy an entire disk or tape ourselves，it is preferable to have the firm generate hard copies of only those portions of the disk or tape which we need to document.

在考虑电子记录的复制时，无论如何，复制的行为必须是合理的，象合理的命令被用在食品、药品和化妆品法规来限定我们该如何去执行检验一样。在一些情况下，复制一个磁盘或磁带可能是合理的，然而在另外的情况下，可能是不合理的，特别在那些为了复制它，我们不得不物理的从设备移动这个磁盘或磁带的地方（考虑和移动一个完整的文件柜类似性，以便我们能复制5页纸的文件。）。我们相信，宁愿自己拷贝整个磁盘或磁带，对于磁盘或磁带中，仅我们需要证明的那些部分，让公司产生一个硬拷贝是更可取的。

3. Record Medium. 21 CFR 211.180(d) states that retained records may be originals or true copies and, when necessary, copying equipment shall be available. This concept applies to magnetic tape and disks.

记录介质。21 CFR 211.180(d)规定保留的记录可以是原始的或真实的副本，在必要时，复制设备应该是可用的。这个概念适用磁性的磁带和磁盘。

4. Record Retention. 21 CFR 211.180(a) states record retention requirements. They are the same for electronic media and paper.

记录保存。21 CFR 211.180(a)规定记录保存的要求。对于电子介质和纸介质要求是一样的。 5. Computer Programs. FD&C Act. Section 704(a)，for prescription drug products, would allow inspectional access to computer programs if such inspection is performed within the constraint of being reasonable.

计算机程序。 对于规定的药品生产，食品、药品和化妆品法规Section 704(a)承认对计算机程序的检查验收，如果这样的检查是在合理的约束内被执行。

There are several factors that must be considered on a case-by-case basis in determining what is reasonable in accessing a firm's computer. For example, the effect on drug production is a factor; specifically, if the process of running a program disrupts drug production in an adverse manner then that would be unreasonable. Another factor is whether or not our manipulations give us access to unauthorized information; the data we may be searching with a program may contain some information we are not entitled to review such as financial data. Consider also that some computer programs are protected by copyright and carefully licensed to software users; thus, we would not be able to copy and use such programs without prior approval of their owners.

有几个因素必须逐项被考虑，决定在访问一个公司的计算机的时候什么是合理的。例如，对药品生产的作用是一个因素；特别，如果一个程序的运行过程用一种不良的方式破坏了药品生产，那么将是不合理的。另一个因素是，是否我们的处理给我们一个使用未经认可的信息的入口。这些数据，我们可以用一个程序搜索的，可能包含一些信息我们没有资格访问的信息，如财务数据。同样，考虑到一些计算机程序被著作权保护并对软件用户的授权，这样，没有程序所有者的预先授权我们将不能复制和使用这样的程序。

6. Record Review. 21 CFR 211.180(e) states that where appropriate records associated with every batch shall be reviewed as part of a periodic review of quality standards. It is acceptable for a firm to conduct part of the review by running a computer program, which culls out analytical data from each batch and conducts trend analysis to determine the need to change product specifications, manufacturing methods, or control part itself must be meaningful (i.e., specified and relevant to enable an evaluation to be performed). It is not necessary to review each and every bit of information on the batch record. However, the computerized trend analysis data would constitute only a portion of the data which must be reviewed。 A review must also be made of records of complaints, recalls, returned or salvaged products, and investigations of unexpected production discrepancies (e.g., yield reconciliation) and any failures of batches to meet their specifications. This information is usually separate from conventional batch records and so would not necessarily be reviewed by the trend analysis program.

记录回顾。 21 CFR 211.180(e)规定适当的记录里面和每一批产品相关联的地方应该作为质量标准定期回顾的一部分被重新检查。对于一个公司通过运行一个计算机程序来进行部分回顾是可以接受的。这个程序是有重要意义的，可以每一批中精选出分析的数据，进行趋势分析来确定改变产品规格，生产方式或自身的控制部分的需要（例如，和一个评估被执行，被详细说明和有关的）。重新检查批记录上的每一个，每一位信息是没有必要的。然而，用计算机处理的趋势分析数据仅由必须被重新检查的数据的一部分组成。为了符合他们的规范，一个重新检查也要由投诉，召回，退回或抢救的产品，未预料到的产品差异性的调查（例如，产品调整）以及任何作废的批的记录构成。这个信息通常是和常规的批记录分开的，因此不需要被趋势分析程序回顾。

7.QC Record Review. 21 CFR 211.192 requires the quality control unit to review and approve production and control records prior to batch release/distribution. If this record screening review (to check errors and anomalies) is computerized and is at least as comprehensive and accurate as a manual review, then it is acceptable for the QC unit to review a computer generated exception report as part of the batch release. The batch record information required by the regulation must still be retained. It is also important that the accuracy and reliability of the screening program be demonstrated. It is unlikely however, that all production and control records will be computerized; labeling, packaging, and analytical records may still be in manual form and would therefore be manually reviewed.

质量控制记录回顾。21 CFR 211.192要求质量控制部门回顾和批准产品以及控制批投放市场/销售前的记录。如果用计算机来筛选回顾的记录（为了检查错误和异常），只要至少和人工回顾一样的全面和精确，那么对于质量控制部门是可以接受的。被规范要求的批记录信息还是必须被保存的。筛选程序的精确性和可靠性被论证也是重要的。然而，所有的生产和控制记录被计算机处理是靠不住的。贴签、包装和分析记录还可以用手工形式。因此将被手工回顾。

8. Double Check on Computer. 21 CFR 211.101(d) requires verification by a second person for components added to a batch. A single check automated system is acceptable if it provides at least the same assurance of freedom from errors as a double check. If it does provide the same assurance then we would gain nothing in applying a redundant second check that adds nothing to assuring product quality. The equivalency of an automated single check system to a manual check must be shown, however, and this might not always be possible. For example, let's say 5 kilograms of a coarse white granular component must be added to a mixture. Two individuals checking the operation may check for the component's label accuracy, color and granularity, weight and finally the actual transfer of the material; if there were a mix-up prior to that transfer and a different component, say a white powder, was staged for addition to the batch it is probable that the double check screening would detect the error. On the other hand, a single check computer system might accurately check the component weight and physical transfer but not its granularity or other sign of identification. In this case the automated single check would not be as good as the manual double check.

计算机的重复检验。21 CFR 211.101(d) 对加到一个批中的组成部分，要求被第二人确认。作为重复检验，如果一个信号检查自动化系统能至少提供同样的没有错误的保证，它是可以接受的。如果它仅能够提供相同的保证，那么我们没有必要应用一个多余的另一个的检验。这个检验不能更加保证产品质量。一个自动的信号检查系统应当是和手工检查是等价的，然而这个可能不总是存在的。例如，让我们假定5千克的粗糙的白色粒状的物质被加到混合物中。两个单独的检查操作，可以校验成分的标签的精确性，颜色和间隔尺寸，重量和最终原料的实际转换；如果在转换前是混乱的，一个不同的成分，假设是白色粉末加到一个批，双重检查筛选发现这个错误是可能的。另一方面，一个信号检查计算机系统，可以正确的检查成分重量和物理变化，但不能检查粒度或其它的确认特征。在这种情况下，自动的信号检查没有两次手工检查好。

9. Documentation. 21 CFR 211.188(b) (11) requires that batch production and control records include identification of each person who conducts, supervises or checks each significant step in the process. The intent is to assure that each step was, in fact, performed and that there is some record to show this, from which the history of the lot could be traced. It is quite possible that an automated system can achieve the same, or higher，level of assurance in which case it may not be necessary to have persons document the performance of each event in a series of unbranched automated events on the production line. For example, let us say an automated/computerized system is designed to perform steps A through Z. If the program is such that every step must be executed properly before step Z is completed then an acceptable means of complying with the regulation would be all of the following:

文件。21 CFR 211.188(b) (11)要求批生产和控制记录，记录要包含对管理，监督的每一个人或每一重要的步骤检查的确认。目的是保证每一步事实上被执行，保证有一些能说明这个执行的记录，大部分的历史是可以追溯的。它是相当可能的，一个自动化的系统能完成相同的或比较高级别的保证，假定让人把生产线上一个连续的无分支的自动化事件里的每一事件的执行文件化可能不是必需的。例如，让我们假定一个自动化的/计算机处理的系统被设计用来执行步骤A到Z。如果程序规定步骤Z被执行前，每步必须被正确执行，那么一个可接受的服从规范的方法将是下面所有列出的：

(1) Documentation of the program; (2) validation that no step can be missed or poorly executed; and (3) documentation of the initial and final steps. It would not be necessary in this example to document steps B through Y.

（１）程序文件；（２）确认没有步骤被丢失或没有充分地执行；（３）原始的和最终的文件。在这个例子里，证明步骤B到Y将不是必须的。

10. Reproduction Accuracy. 21 CFR 211.188(a) requires the batch record to contain a reproduction of the master record. The intent is to insure that the batch was, in fact, produced according to the approved formulation, manufacturing instructions and controls. The act of computer transcription can generate errors. The firm should check for such errors or otherwise assure that no errors can occur. During the inspection the

investigator can ask to see the original approved, endorsed, master record and compare it to the batch record. The fact that the batch record is a second or third generation copy is not in and of itself objectionable provided it is accurate.

精确再现。21 CFR 211.188(a)要求一个包含主要记录的附件的批记录。目的是为了确保事实上这批被生产，依照被认可的配方，生产指令和控制。计算机转录的行为可以产生错误。公司应该核查这样的错误，否则保证没有错误产生。在验证期间，审查者可以要求看原始的被批准的，署名的主控记录并和批记录作比较。，

11. NDA Considerations. 21 CFR 314.8 requires that a supplement be submitted for changes in manufacturing/control processes or facilities from those stated in the approved NDA. If a firm has changed from a manual to a computerized system under an NDA, that change should be covered by a supplemental application. If the change gives increased assurance of product quality, then the change can be put into effect before the supplement has been approved. However, such supplements should state the anticipated implementation date (which should be sometime after the submission date) to allow reviewing chemists the lead time needed to determine if the type of change proposed is, in fact, of the kind which may be implemented prior to approval.

新药申请考虑因素。21 CFR 314.8要求对于被认可的新药，针对那些规定的在制造/控制过程或设备方面的变更提交一个补充。如果一个公司已经对一个新药，进行了手动到自动化控制系统的改造，那么这个改造应该包括在补充申请里。如果这个改造能增强产品的质量，这个改造可以在修订被批准前被实施。然而，这样的补充应该陈述允许药剂师检查的，预先的执行数据。事实上，如果被提议的改造类型是那种可以在被批准前执行，交付时间需要被确定。 GLOSSARY术语表

ADDRESS A switch pattern that identifies the location of a piece of data or a program step.

引导 一个开关模式，用来确定一块数据或一个程序步骤的位置

ALGORITHM A systematic procedure or equation designed to lead to the solution of a problem in a finite number of steps.

运算法则 一个系统的方法或等式，它是为了使一个问题在有限多的步骤内被解决而被设计。 ALU Arithmetic Logic Unit; the circuitry within the CPU which performs all arithmetic functions.

算术逻辑单元 算术逻辑单元；CPU内部的可以完成所有算术运算的电路

ANALOG Continuous signal having a voltage which corresponds to the monitored value.

模拟量 连续的符合监控值的电压信号

APPLICATIONS应用软件 Term used to describe software written to perform tasks on a computer.

用来描述用来在计算机上执行任务的软件的一个术语 。

ASCII 美国信息交换标准码 American Standard Code for Information change; a system used to translate keyboard characters into bits.

美国信息交换标准码；一个被用来转换键盘字符成为二进制的系统

ASSEMBLER汇编程序 Program which translates assembly code to executable machine code; e.g. assembly code ADD becomes machine code 04.

一个将汇编源代码转换成为可执行的机器代码的程序。例如，汇编代码ADD被转换成为机器代码04。 ASSEMBLY CODE汇编代码 Symbolist, a simple language; Different computers have different assembly codes.

符号集合，一个简单的语言；不同的计算机有不同的汇编代码。

ASYNCHRONOUS 异步的 Term used to describe the exchange of information piece by piece rather than in long segments.

一个描述 信息被一部分一部分的而不是用一个长的程序段的方式交换的术语。

AUXILIARY STORAGE 辅助存储设备 Storage device other than main storage; disks and tapes.

不同于主存储器的存储设备；磁盘或者磁带。

BASIC 一种计算机高级语言 Beginner's All Purpose Symbolic Instruction Code; a high level language.

初学者的全部目的符号指令代码，一种高级语言

BATCH PROCESSING批处理 Execution of programs serially with no interactive processing. 程序连续执行，没有交互处理。

BAUD 波特率 The rate at which data is received or transmitted in serial: one baud is one bit per second.

用串行方式接收或者发送数据时的速率；波特率为一就是指每秒钟一位数据。

BINARY 二进制 The base two number system. Permissible digits are 0 and 1. 二进制，可允许的阿拉伯数字是0和1。

BIT 位 Binary Digit; the smallest unit of information in a computer, represented as 0 or 1, off or on for a switch.

二进位的阿拉伯数字；计算机里面信息的最小单位，用0或1描绘，作为一个开关的开或关。 BOOT 导入An initialization program used to set up the computer when it is turned on. 一个初始化程序，当计算机被打开时，用来开启计算机，

BUFFER 缓冲器 Part of memory used to temporarily hold data for further processing. 存储器的一部分，被用来临时的保存数据，以便进行更进一步的处理。

BUG 一个程序错误 A program error.

BUS 总线 Electrical pathway by which information flows to different devices. 不同设备间，信息流通的电子路径。

BYTE 字节 A sequence of adjacent bits, usually eight, operated upon as a unit; the lowest addressable unit in a computer.

一定次序的邻近位，通常是8位作为一个单位起作用。计算机中，可设定地址的最小单位。 COMPILER 编译器 Program which translates a computer language into executable machine code. A compiler translates an entire program before the computer runs the program.

将计算机语言翻译成为可执行的机器代码的一个程序。在程序运行前，编译器翻译整个程序。 CP/M 微型计算机的控制程序 Control Program for Microcomputers; a registered trademark of Digital Research; an operating system.

微型计算机的控制程序；一个已经注册的商标的数字系统，一个操作系统。

CPU 处理器 Central processing unit of a computer where the logic circuitry is located; the CPU controls the entire computer; it sends and receives data through input-output channels，retrieves data from memory and conducts all program processes.

一个计算机的处理单元，逻辑电路位于其中。CPU控制整个计算机。它通过输入－输出通道发送和接收数据，从内存中取回数据，并且管理所有程序的运行。

CRT TERMINAL 显示器终端 Cathode ray tube; an input/output device. 阴极射线管；一个输入/输出设备。

DATABASE 数据库 Collection of data, at least one file，fundamental to a system. 数据的集合体，至少一个文件，对系统很重要。 DATA SET数据集 Term synonymous with file. 和文件同义。

DIGITAL数字式 Relating to separate and discrete information. 与分散的不连续的信息有关的。

DISK 磁盘 A circular rotating magnetic storage device. Disks come in different sizes and can be hard or flexible.

一个圆形旋转磁场存储设备。磁盘有不同尺寸，能被制成软的或硬的。

DISK DRIVE 磁盘驱动器 A device used to read from or write to a disk or diskette. 一个被用来从磁盘或磁碟中读出数据，或写数据到磁盘或磁碟的设备。

DISK OPERATING SYSTEM 磁盘操作系统 DOS, a program which operates a disk drive.

一个操作磁盘设备的程序。 DISKETTE 磁盘 A floppy disk. 一个软盘

EPROM 电可编程只读存储器Erasable programmable read only memory: Switch pattern in circuit can be erased by exposure to ultraviolet light.

可擦除的，可编程的只读存储器；电路中的数据能被擦除通过暴露在紫外光中。

FILE 文件 Set of related records treated as a unit, stored on tape or disk; Synonymous with data set.

作为一个单位的一系列有关系的记录，被保存在磁带或者磁盘上 ；和数据集同义。 FIRMWARE 固件 A program permanently recorded, e.g., in ROM. 一个程序被永久不变的保存，例如，在ROM中。 HARD COPY 硬拷贝 Output on paper. 输出打印到纸上

HARDWARE硬件 Physical electronic circuitry and associated equipment. 物理电子电路和相关的装置。

HEXADECIMAL十六进制 The base 16 number system. Digits are 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, A, B, C，D, E, AND F. This is a convenient form in which to examine binary data because it collects 4 binary digits per hexadecimal digit. E.g. Decimal 15 is 1111 in binary and F in hexadecimal.

十六进制数。 数字是0, 1, 2, 3, 4, 5, 6, 7, 8, 9, A, B, C，D, E, 和 F。这是一个方便的，表示二进制数据的形式 因为每个十六进制数的数字由4个二进制数集合而成。例如，十进制的15用二进制表示是1111，用十六进制表示是F。

INTEGRATED CIRCUIT (IC) Small wafers of silicon etched or printed with extremely small electronic switching circuits; also called CHIPS.

集成电路（IC）小的用极小的电子开关电路蚀刻或印刷的硅晶片，也被称作CHIPs。

INTERACTIVE PROCESSING 交互式处理 An application in which each entry calls forth a response from a system or program, as in a ticket reservation system. 一个应用程序 如票务预订系统。

INTERFACE 接口 A device which permits two or more devices to communicate with each other.

一个允许两个或多个设备相互通讯的设备。

INTERPRETER 解释程序 A program which translates a high level language into machine code one instruction at a time. Each instruction in the high level language is executed before the next instruction is interpreted.

一个翻译高级语言程序成机器代码的程序，每次一条指令。用高级语言写的指令在下一条指令被翻译前执行。

I/O PORT 输入/输出端口 Input/output connector. 输入/输出连接器

JOB 作业 Set of data completely defining a unit of work for a computer. 表示计算机的工作单位的一系列的数据。

K 千字节 Symbol representing two to the tenth power, 1024, usually used to describe amounts of computer memory, and disk storage, in bytes. 通常被用来描述计算机内存的数量和磁盘的存储。

LANGUAGE语言 Any symbolic communication media used to furnish information to a computer. Examples are PL/1, COBOL, BASIC, FORTRAN, and ASSEMBLY. 被用来给计算机提供信息的通讯符号。例如，PL/1,COBOL,BASIC,FORTRAN和汇编。 LOADER 装入程序 A program which copies other programs from external to internal storage.

一个可以将在外部存储器上的其它程序拷贝到内部存储器的程序。

MACHINE CODE 机器代码 Numerical representations directly executable by a computer; Sometimes called machine language. 被计算机直接执行的用数字表示的陈述。

MAIN STORAGE 主存储器 Term synonymous with MEMORY. 和MEMORY同义的术语。

MAINFRAME 大型机 Term used to describe a large computer. 用来描述一个大型计算机的术语。 MEGABYTE 兆字节 1024K Bytes 1024K字节

MEMORY 存储器A non-moving storage device utilizing one of a number of types of electronic circuitry to store information.

一个利用若干种电子电路中的一种来存储信息的固定的存储设备。

MENU 菜单 A CRT display listing a number of options. The operator selects one of the options. Sometimes used to denote a list of programs.

一个显示器列出的若干操作。操作工选择这些操作中的一个。有时被用来表示程序单。

MICROCOMPUTER 微型计算机 A small computer (See MICROPROCESSOR). 小型计算机

MICROPROCESSOR 微处理器 Usually a single integrated circuit on a chip; Logic circuitry of a microcomputer; frequently synonymous with a microcomputer。 A microprocessor executes encoded instructions to perform arithmetic operations, internal data transfer, and communications with external devices.

通常指一个芯片内的单一的完整的电路；微型计算机的逻辑电路；和microcomputer同义。一个微处理器执行被编码指令以实现数算操作，内部数据传递以及和外部设备的通讯。 MINICOMPUTER 小型机 Medium sized computer. 中等大小的计算机

MODEM 调制解调器 Modulator - demodulation, a device which accepts data from a computer, and sends data to a computer, over telephone wires or cables. A half duplex MODEM can only receive or transmit data at one time. A full duplex MODEM can receive and transmit data at the same time.

调制解调器，一个通过电话线或电缆从计算机中接收数据，并送数据到计算机的装置。一个半双工的调制解调器在同一时间仅能接收或发送数据。一个全双工的调制解调器在相同时间能同时接收和发送数据。

MULTIPLEXER 复用器 A device which takes information from any of several sources and places it on a single line.

从任意几个来源获取数据，然后放置到一根线路上的设备。

NETWORK 网络 A system that ties together several remotely located computers via telecommunications.

通过通讯线路，将几个远程放置的计算机连接在一起的系统。

OBJECT CODE 目标代码 Term synonymous with machine code. 和机器代码同义的术语

OEM 原始设备制造商 Original Equipment Manufacturer (i.e. Maker of computer hardware)。

原始设备制造商（例如，计算机硬件的制造者）

OPERATING SYSTEM 操作系统 Set of machine language programs that run accessories, perform commands and interpret or translate high level language program (usually written into the ROM).

一套由机器语言编写地程序，能够运行辅助程序，执行命令或中断，或者解释高级语言程序（通常被写入ROM）。

PARALLEL 并行 Term to describe transmission of data eight bits (one byte) at a time.

描述8位（一个字节）一起被传送的术语。

PARITY BIT 奇偶校验位 An extra bit within a byte；used to verify the coded information in the byte itself. The extra bit is either a one or zero so as to make the total number of ones in a byte equal either an odd or even number (odd or even parity). 一个字节内的一个特殊的位，被用来校验字节自身编码信息。

PERIPHERAL 外围设备 A general term used to describe an input or output device. 一个用来描述输入和输出设备的通用术语。

PROGRAM 程序 collection of logically interrelated statements written in some computer language which, after translation into machine code, performs a predefined task when run on the computer.

用某一种计算机语言写成的逻辑上相关的陈述的集合。翻译成机器代码后，在计算机上运行它是，可以完成预定的任务。

PROM 可编程的只读存储器 Programmable read only memory; once programmed the switch pattern on a PROM cannot be changed. Special equipment separate form the computer is usually used to \"burn in\" the switch pattern. 可以编程的只读存储器，一旦数据被写入便不能被改变。

PROTOCOL协议Agreed upon set of standards which allow communication between computers, i.e. Physical electrical links, message format, message priorities, etc. 允许在计算机之间通讯的一系列被批准的标准。例如，硬件电气连接，信息格式，信息优先权等。 RAM 随机存取存储器 Random access memory; internal storage device containing volatile information which can be changed; read-write memory. When electrical power is cut off from a RAM IC its memory is lost.

随机存取存储器，存储能被改变的可变信息的内部存储设备。读写存储器。当存储器芯片的电源被切断时，信息被丢失。

RECORD 记录 Collection of related data treated as a unit. 被作为一个单元的相关数据集合。

SERIAL 串行 Term to describe handling of data one bit at a time. 一个术语，描述一次一位处理数据。

ROM 只读存储器 Read only memory；Internal storage device in which information is permanent。

只读存储器，可以永久保存信息的内部存储设备。

RS-232C 一种通讯标准 An Electronic Industries Association(EIA) standard for connecting electronic equipment; Data is transmitted and received in serial format. This is an interface standard that usually uses a 25 pin connector.

电子工业协会制定的电子设备连接标准。数据用串行方式传送和接收。这是一个通用的接口标准。 SOFTWARE 软件 Programs executable on a computer. Programs are written in any number of different languages.

在计算机上执行的程序。程序可以被写，用任何不同的语言。

SOURCE PROGRAM 源程序 High level language program which the operator can read. 用高级语言编写的，能够被操作人员阅读的东西。

STORAGE DEVICE 存储设备 A unit into which can be placed, retained and retrieved. 一个能放置，保持和查阅数据的单元。

SYNTAX 语法 Required grammar or structure of a language. 一种语言的必须的语法和结构

SYSTEM 系统 Term can refer to hardware or software. For hardware it is the collection of equipment that makes up the computer. For software it refers to an integrated number of computer programs to perform predefined tasks.

一个涉及硬件或软件的术语。对于硬件，它是计算机构成的设备的集合。对于软件，它是能完成预定任务的计算机程序的整体。

TAPE 磁带 A liner magnetic storage device rolled onto a reel or cassette. 被绕在卷轴或盒子上的带状的磁存储设备

TELECOMMUNICATION SYSTEM 远距离通信系统 The devices and functions relating to transmission of data between the central processing system and remotely located users. 处理系统与远处使用者之间数据传送相关的设备和函数。

TERMINAL终端 A device, usually equipped with a CRT display and keyboard, used to send and receive information to and from a computer via a communication channel.

一个装置，通常装备显示器或键盘，用来通过通讯线路输入信息到计算机以及从计算机中输出信息。 UTILITY PROGRAMS 实用程序 Special programs usually supplied by the producer of the operating system. They perform general functions such as making back up copies of diskettes and copying files from tape to disk.

通常由操作系统的生产者提供的专用的程序。这个程序一般的功能，诸如制作磁盘的副本和拷贝文件从磁带到磁盘。

VALIDATION确认 The assurance, through testing, that hardware or software produces specified and predictable output for any given input.

通过测试，确保对于任意给定输入硬件或软件产品能够给出指定的或预定的输出。

WORD 字 One or more adjacent bytes conveniently considered as an entity. A word is usually one to four bytes long, depending on make of computer.

由一个或多个相邻的字节组成的实体 。通常一个字的长度为一到四个字节，具体依赖于计算机的构造。