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USP 40 《1058 分析仪器确认》第三部分翻译3

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发表于 2019-1-7 10:40:20 | 只看该作者 回帖奖励 |倒序浏览 |阅读模式
ROLES AND RESPONSIBILITIES
角色和职责

Users
用户

Users are ultimately responsible for specifying their needs and ensuring that a selected instrument meets them, and that data quality and integrity are maintained. The user's group encompasses analysts, their supervisors, instrument specialists, and organization management. 1S (USP40) Users should be adequately trained in the instrument's use, and their training records should be maintained as required by the regulations.
用户最终负责指定他们的需求并确保所选定的仪器符合他们的要求,并确保数据质量和完整性得到维护。用户组包括分析员,他们的主管,仪器专家和组织管理者。1S (USP40)用户应在仪器的使用方面接受充分的培训,其培训记录应按照规定的要求进行维护。

Users should also be responsible for qualifying their instruments, because their training and expertise in the use of instruments make them the best-qualified group to design the instrument test(s) and specification(s) necessary for a successful AIQ. Consultants, instrument manufacturers or suppliers, validation specialists, and quality assurance personnel can advise and assist as needed, but the final responsibility for qualifying instruments and validating systems lies with the users, who must ensure that the instrument is maintained in a qualified state through routine performance of PQ. 1S (USP40)
用户还应负责对其仪器进行确认,因为他们在仪器使用方面接受的培训和专业知识使他们成为最佳的确认团队,可以为AIQ的成功实施设计必须的仪器测试项目和规范。顾问,仪器制造商或供应商,验证专家和质量保证人员可以根据需要提供建议和帮助,但是确认仪器和验证系统的最终责任在于用户,他们必须确保仪器日常的PQ性能始终保持验证状态。1S (USP40)

Quality Unit
质量部


The role of the quality unit in AIQ remains the same as for any other regulated activity. Quality personnel are responsible for ensuring that the AIQ process meets compliance requirements, that processes are being followed, and that the intended use of the instrument is supported by complete, 1S (USP40) valid, and documented data.
质量部门在AIQ中的作用与任何其他受监管活动的作用相同。质量人员负责确保AIQ过程符合要求,程序得以遵循,并且仪器的预期用途由完整的、1S (USP40)有效的且记录在案的数据支持。
1S (USP40)

Manufacturers, Suppliers, Service Agents, and Consultants
制造商,供应商,服务代理商和顾问

Manufacturers are responsible for designing and manufacturing the instrument, and ensuring the quality of relevant processes used in manufacturing and assembly of the instrument. Manufacturers should test the assembled instruments before shipping them to users. To aid the user, suppliers are responsible for developing meaningful specifications for the users to compare with their needs and aid selection.
制造商负责设计和制造仪器,并确保仪器制造和组装使用的相关工艺的质量。将组装好的仪器在运送给用户之前应由制造商进行测试。为了帮助用户,供应商负责为用户开发有意义的功能规范,以便符合用户需求和帮助选择。

Where used, software should be developed and tested using a defined life cycle and should have evidence of work performed to support major and minor revisions. Release notes should accompany each version of software released. 1S (USP40)
在使用时,软件应该使用定义的生命周期方式进行开发和测试,并且应该有支持主要和次要修订的工作证据。版本说明应兼有软件发布的每一个版本。1S (USP40)

Finally, it is desirable that suppliers1S (USP40) should notify all known users about hardware or software 1S (USP40)defects discovered after a product's release; offer user training, service, repair, and installation support; and invite user audits as necessary.
最后,供应商1S (USP40)应该通知所有已知用户关于产品发布后发现的硬件或软件1S (USP40)缺陷; 为用户提供培训,服务,维修和安装支持; 必要时邀请用户进行审计。

There should be a quality or technical agreement between the user organization and manufacturers, suppliers, service agents, or consultants who supply calibration, maintenance, qualification, or validation services; the agreement should define the scope of work and the responsibilities of the two parties. 1S (USP40) 1S (USP40)
用户组织与提供校准,维护,确认或验证服务的制造商,供应商,服务代理商或顾问之间应有质量或技术协议; 该协议应规定他的工作范围和双方的责任。1S (USP40)


SOFTWARE VALIDATION
软件验证

There is an increasing inability to separate the hardware and software parts of modern analytical instruments. In many instances, the software is needed to qualify the instrument, and the instrument operation is essential when validating the software. Therefore, to avoid overlapping and potential duplication, software validation and instrument qualification can be integrated into a single activity.
现代分析仪器的硬件和软件部分越来越难以分开。在很多情况下,需要用软件来确认仪器,而仪器操作在验证软件时亦是必不可少的。因此,为了避免重叠和潜在的重复工作,软件验证和仪器确认可以整合到一个活动中。

Software used for analytical instruments can be classified into four groups: firmware, instrument control software, data acquisition software, and processing software. Although software validation is not the primary focus of this chapter, the following sections describe in which cases this activity is within the scope of the analytical instrument and system qualification.
分析仪器的软件可以分为四类:固件,仪器控制软件,数据采集软件和处理软件。虽然软件验证不是本章的主要重点,但以下各节将介绍在哪些情况下,分析仪器和系统验证包括该活动。

One source of the validation of software is the guide GAMP: A Risk-Based Approach to Compliant GxP Computerized Systems. 1S (USP40)
软件验证的一个来源是GAMP指南:基于风险的GxP合规实验室计算机化系统方法。1S (USP40)

Firmware
固件

Computerized analytical instruments contain integrated chips with low-level software (firmware). Such instruments will not function without properly operating firmware, and in most cases1S (USP40) users generally cannot alter firmware1S (USP40)function. Firmware is therefore considered a component of the instrument itself. Indeed, the qualification of hardware is not possible without operating it via its firmware.
计算机化的分析仪器包含带有低级软件(固件)的集成芯片。如果没有正确操作固件,这些仪器将无法正常工作,并且在大多数情况下1S (USP40),用户通常无法更改固件1S (USP40)功能。固件因此被认为是仪器本身的组成部分。事实上,如果没有通过固件进行操作,硬件的确认是不可能的。

Thus, when the hardware (that is, the analytical instrument) is qualified at the user's site, the 1S (USP40)firmware is also essentially qualified. No separate on-site qualification of the firmware is needed. Whenever possible, the firmware version should be recorded as part of the IQ activities. Any changes made to firmware versions should be tracked through the change control of the instrument (see Change Control, below).
因此,当在用户现场对硬件(即分析仪器)进行确认时,本质上也对1S (USP40)固件进行了确认。在现场对固件进行单独确认是不需要的。尽可能将固件版本作为IQ活动的一部分记录下来。应通过仪器的变更控制来跟踪对固件版本所做的任何更改(请参阅下面的变更控制)。

In some instruments, firmware can also be capable of fixed calculations on the acquired data. These calculations need to be verified by the user. Some instruments have firmware that enables users to define programs for the instrument's operation; similarly, these user-defined programs need to be defined and verified to demonstrate that they are fit for the intended purpose. Any user-defined programs should be placed under change control and, if possible, access should be restricted to authorized personnel. 1S (USP40)
在某些仪器中,固件也可以对获取的数据进行固定计算。这些计算需要由用户确证。一些仪器具有让用户定义仪器操作程序的固件; 同样,这些用户定义的程序需要进行定义和确证,以证明它们适合于预期目的。任何用户定义的程序都应该置于变更控制之下,并且如果可能的话,访问应限于被授权人员。1S (USP40)

Instrument Control, Data Acquisition, and Processing Software
仪器控制,数据采集和处理软件

Software for instrument control, data acquisition, and processing for many of today's computerized instruments is loaded on a computer connected to the instrument. Operation of the instrument is then controlled via the software, leaving fewer operating controls on the instrument. Also, the software is needed for data acquisition and post-acquisition calculations. Thus, both hardware and software, their functions inextricably intertwined, are critical to providing analytical results.
今天许多计算机化仪器的控制软件,数据采集和处理软件被加载到了与仪器连接的计算机上。然后通过软件控制仪器的操作,从而使仪器上的操作控制更少。此外,还需要该软件进行数据采集和采集后计算。因此,硬件和软件两者的功能不可分割地交织在一起,对于提供分析结果至关重要。

The software in this group can be classified into three types: 1) non-configurable software that cannot be modified to change the business process; 2) configurable software that includes tools from the supplier to modify the business process; and 3) configurable software with custom additions (i.e., custom software or macros to automate the business process).
该类软件可以分为三种类型:1)不可配置软件,不可对其修改以改变业务流程; 2)可配置软件,包含供应商提供的工具以修改业务流程; 和3)可自定义添加的可配置软件(即自定义软件或宏来自动执行业务流程)。

The supplier of the system should develop and test the software according to a defined life cycle and provide users with a summary of the tests that were carried out. Ideally, this software development should be carried out under a quality management system.
系统的供应商应根据定义的生命周期开发和测试软件,并向用户提供所执行测试的摘要。理想情况下,这个软件开发应该在质量管理体系下进行。

At the user site, integrated qualification of the instrument, in conjunction with validation of the software, involves the entire system. This is more efficient than separating instrument qualification from validation of the software. 1S (USP40)
在用户现场,与软件验证整合在一起的仪器确认涉及整个系统。这比将仪器确认与软件验证分开更有效。1S

CHANGE CONTROL
变更控制

Changes to qualified instruments, including software, become inevitable as suppliers add new features and correct known defects. However, implementing all such changes may not always benefit users. Users should therefore adopt changes they deem useful or necessary. Changes also occur due to repair, maintenance, or relocation of the instrument. A change control process should be in place to guide the assessment, execution, documentation, and approval of any changes to instrumentation.
已确认仪器(包括软件)的变更不可避免,如供应商添加新功能和纠正已知缺陷,但是,实施所有这些变更可能并不总是有益于用户。因此,用户应该采用他们认为有用或必要的变更。维修,维护或重新安置仪器,也会导致变更。应该有一个变更控制过程来指导评估,执行,记录和批准对仪器的任何变更。

Change control applies to all elements of qualification and may follow the general qualification process. Users should assess the effects of changes to determine what, if any, requalification activities are required. If implementation of the change is needed, install the changes to the system. Consider if the change will affect the ability of the instrument to meet the user requirements or if the user requirements have changed. Evaluate which of the existing OQ and PQ tests need revision, deletion, or addition as a result of the installed change.
变更控制适用于所有确认要素,并遵循一般确认流程。用户应评估变更的影响,以确定哪些确认活动需要重新进行(如果有的话)。如果需要实施变更,将更改安装到系统中。考虑这种变更是否会影响仪器满足用户要求的能力或用户要求是否发生了变化。针对安装变更的结果,评估现有的OQ和PQ中哪些测试需要修订,删除或添加。

After implementation, perform any required testing to evaluate the effects of the change. Document all details of the change. Include a description of the change and a rationale, and list appropriate identification (e.g., part and serial numbers of new components and versions of new software or firmware). 1S (USP40)
实施后,执行任何所需的测试以评估变更的效果。记录变更的所有细节。包括变更描述和理由依据,并列出适当的标识(例如,新组件的部件和序列号以及新软件和固件的版本号)。1S (USP40)

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