警告信精选W194-W156(中英文版)
FDA Warning Letters,Form483Observations,Establishment Inspection Reports
FDA警告信，483缺陷表，检查报告
Important:Warning letters should be interpreted in the context of full content.Just looking at extracts may be misleading.And sometimes they include good advice from the FDA not mentioned in the extracts.
重要的警告信可能会用完整的上下文内容来解释。只看摘要可能会导致误解。有时候完整的内容会包含摘要中没有包括的来自FDA的建议。
W-194
Keywords:GLP,raw data,reason for change,responsibilities of QAU,integrity of study data
关键词：GLP,原始数据，变更理由，质保责任，研究数据的完整性
?Primary Deviations:Incomplete study records,no reason for change of study records,QAU not fulfilled its responsibilities,raw data,no assurance of the quality and integrity of study report, no final study report,no or inadequate testing and calibration of equipment
?主要错误：研究数据不完全，没有理由地改变研究记录，质保未履行职责，原始数据，研究报告的质量和完整性没有保证，没有最终研究报告，检测和仪器检验没有或不够。?Examples:
-Failure of the study director to assure that all experimental data were accurately recorded and verified and document the reason for any change in the entries
-For study xxx your study director failed to assure that dosing were accurately recorded to confirm that study animals received protocol-specified doses of the vehicle.
-Failure of QAU to assure that reported results in the final study report accurately reflected the raw data
-Failure of QAU to maintain written and properly signed records of each periodic inspection
-Failure to identify the test and control articles with appropriate characteristics in the final report -Failure to adequately test,calibrate,and/or standardize all equipment used the generation, measurement and assessment of data
?事例：
研究主管未能保证所有的实验数据被准确记录，也未能确认任何条目的变更理由并记录。为研究xxx，你们的研究主管未能保证准确记录剂量以确保试验动物接受研究草案中规定的剂量
质保未能保证最终研究报告中的结果准确反映原始数据
质保未能在阶段性的检查中持续填写记录并适当签名
在最终研究报告中没有用合适的特定的格式来鉴别测试和控制内容
没有对产生，测量及评估数据的设备进行足够的测试，校准和/或标准化
W-193
Keywords:Batch records,method validation,cleaning validation,equipment calibration
关键词：批记录，方法验证，清洁验证，设备校准
?Primary Deviations:Incomplete batch records,insufficient documentation of method validation,inadequate documentation of laboratory equipment calibration,shipment of APIs to US from non certified manufacturing site
?主要错误：批记录不完整，方法验证文件不够，实验室设备校准文件不充分，从未经确认的生产地点向美国出货
?Examples:
-Batch production records do not include complete information relating to the production and control of each API batch
-Method validation documentation did not include appropriate data to verify that the analytical method produced accurate and reliable data
-Production equipment was not adequately cleaned and was not maintained in a good state of repair
-Laboratory equipment calibration was not adequately documented.
事例：
批生产记录没有包括与每个批次的生产与控制相关的完整信息
方法验证文件没有包含适当的数据以确认分析方法能产生准确和可靠数据
生产设备清洁不够，且在修理状态下没有维修
实验室设备校准没有被完全记录
W-192
Keywords:Data security,raw data,passwords,laboratory software
关键词：数据安全性，原始数据，密码，实验室软件
?Primary deviations:no individual passwords,ability to overwrite raw data.
?主要错误：没有个人密码，可以改写原始数据
?Examples:
-Validation of the(brand name)laboratory software used to control instruments,generate data, perform calculations,and store data from raw material and finished product testing failed to demonstrate adequate security.Analysts have the ability to overwrite original data,
and are not required to utilize the protection of individual passwords.
-The corresponding EIR further states:During discussions and lab demonstrations,it was determined that neither system prevents analysts from overwriting original raw data.A review of the software validation showed initial failures for modules demonstrating the ability to delete or overwrite data.Documentation in the validation report stated that this capability could not be changed.During the laboratory demonstration,I observed the statement,"Data will be overwritten"with the option to ignore this.
-In addition to the ability to overwrite original data,the analysts are not required to utilize the protection of passwords since they are considered to have"limited access".I stated that each analyst needs to have their own password to access the system to help ensure data security and to track the usage by individuals.
?事例：
用来控制设备，产生数据，进行校准，储存原料和成品检验数据的实验室软件的验证中没有论证安全性。分析人员能够改写原始数据。没有要求对个人密码进行保护
相对应的EIR状态：在讨论和实验室论证中发现，系统并不能防止分析人员改写原始数据。软件验证回顾表明记录数据删除和数据改写的模块最初就失灵了。验证报告文件中表明这种能力不能被改变。在实验室论证中，我看到不予理会“数据可以被修改”的声明。
除了修改原始数据的能力外，分析人员没有要求保护密码，尽管他们也认为登陆要受到控制。我建议每个分析人员都需要用自己的密码来登陆系统以确保数据安全及跟踪个人使用情况W-191
Keywords:Vendor software,software validation
关键词：供应商软件，软件验证
?Primary deviations:vendor supplied computer software not validated,
?主要错误：供应商提供未经验证的软件
?Examples:
?事例
-The performance of the computer software has not been verified.Specifically your firm has not verified your computer software program in all aspects of their donor referral operations to ensure that electronic records are trustworthy,accurate and reliable.The related EIR further explained:The firm uses a computer software program called(brand name)that is manufactured by(vendor name).
计算机软件性能未经确认，特别是你公司未确认所有捐赠转诊方面的计算机软件程序以确保电子纪录是可信，准确和可靠的。相关的EIR解释：公司使用某公司生产的某软件。
-During the inspection,I asked if the computer software has been validation to assure that it performs for it's intended use.I was told that the software was validated by the manufacturer.The managing director provided me a copy of the letter the received from(the vendor).The letter indicated that the software was validated.She also the gave me a copy of validation information that was obtained from(the vendor)during the inspection.
在检查中，我问计算机软件是否已验证，确保能实现预计的功能。答案是软件已由生产商验证。管理者提供了一份供应商的信件的复印件。信件表明软件已验证。在检查中，她还提供了从供应商处获得的验证信息的拷贝。
-I told the managing director I still need to see what they have done to validate the system since the computer was making a decision to accept or reject potential donors.The managing director and the Manager of the Communications Center told me that they were unaware they the company had to validate the software because it was validated by(the vendor)and that was their reason for purchasing the version of software instead of the COTS(Commercial Off The Shelf) version of the software that is also manufactured by(the vendor).
我告诉管理者，由于由计算机决定接受或拒绝可能的捐赠者，所以我需要了解他们如何验证系统。管理者和交流中心的经理告诉我他们没有意识到他们必须对供应商验证过的软件进行验证。他们购买这个版本的软件而不是商业现成版，也是因为这个版本的软件供应商已经验证过（商业现成版也由同一供应商生产）。
W-190
Keywords:IQ,OQ,PQ,retrospective validation,legacy systems,no review of electronic records 关键词：IQ,OQ,PQ,回顾性验证，遗赠系统，没有电子纪录的回顾
?Primary deviations:no validation of legacy systems,no formal change control.no design control for customized software elements,no review of electronic records
主要错误：没有遗赠系统的验证，没有正式的变更控制，没有对定制的软件要素进行设计控制，没有电子纪录的复核
?Examples:
事例：
-No IQ,OQ or PQ has been performed throughout the life of the system.No validation reports have been generated historically.
在系统的整个使用周期中没有进行IQ,OQ,PQ。没有验证报告。
-Current efforts to retrospectively validate the system have progressed through the approval of an IQ protocol,however,this protocol has not yet been executed.OQ and PQ efforts have not yet
been developed as part of these current validation efforts.
现在的努力是对系统进行回顾性验证，已批准IQ草案，但还未实施。OQ,PQ还未作为现阶段验证的一部分。
-The(system)has not been maintained under established procedures for change control.This is true throughout the life of this software application.
系统没有在已建立的变更程序下进行维护。在整个软件使用过程中都是如此。
-The firm has failed to generate or maintain design control documentation sufficient to define all customized elements making up the(system)configuration(i.e.,functional or structural design documentation defining all program making up(the system)
该公司未能产生或维护足够的设计控制文件以定义所有构成系统的定制的要素（比如：定义构成系统的所有程序的功能性或结构性设计）
-Electronic records generated during manufacture of APIs were not reviewed prior to release of validation lots or for any lots manufactured thereafter to include the most recently released API lot.
在验证批或之后生产的任何批次放行前没有复核在生产APIs过程中产生的电子记录。最近放行的批次也是如此。
W-189
Keywords:Microsoft Excel,Microsoft Word,Off-the-shelf software,Validation
关键词：微软Excel,微软Word,现成软件
?Primary deviations:Off-the shelf software not validated
主要错误:现成软件没有验证
?Examples:
事例：
Failure to assure that when computers or automated data processing are used as part of the production or quality system the manufacturer shall validate computer software for its intended use according to an established protocol,as required by21CFR820.70(i).
没有按照21CFR820.70(i)要求制定草案来确保作为生产或质量系统的一部分的计算机或自动数据处理会被验证，以满足计划的使用目的。
-Electronic records are used but there was no software validation.
使用电子记录但软件未经验证。
-No procedures are established to validate for its intended purpose the Microsoft Word or Microsoft Excel software used in creating and maintaining nonconformance records,product return records,internal audit corrective records,or corrective action records.
没有制定程序来验证微软Excel和微软Word软件，这些软件计划用在产生或维持不符合记录，产品退回记录，内部审计纠正记录或整改记录。
W-188
Keywords:Laboratory,Electronic Audit Trail,Chromatographic integration
关键词：实验室，电子审计追踪，色谱综合性能
?Primary deviations:No or inadequate electronic audit trail,no audit trail for chromatographic reintegration
主要错误：没有或电子审计追踪不够，没有色谱完整性能审计追踪
?Examples:
事例：
-Operations that could affect the integrity of chromatographic data files…are not controlled by
electronic audit trails that maintain who,why and what was changed to any given sample record 能够影响色谱数据文件的操作没有被电子审计追踪控制，这种跟踪是显示任何样品纪录为什么以及怎样被改变的。
-There are no records of user transactions when data is deleted,copied,renamed or purged
当数据被删除，复制，重命名或者清除时没有使用者操作记录。
-The firm can not determine if reintegration of a sample occurred once or several times。
公司没有决定样品重组是进行一次还是几次。
W-187
Keywords:Stability Testing,Quality Control Unit,Laboratory investigations,electronic audit trail,automated computer time-out,method validation,method transfer
关键词：稳定性测试,质控，实验室调查。电子审计追踪，计算机自动暂停，方法验证，方法转移
?Primary deviations:Electronic audit trail not reviewed,electronic audit trail does not identify the the person who made the change,no automated computer time-out,operators and supervisors can delete raw data,raw data from contract testing labs not reviewed,proper functioning of established methods not verified after modifications,no follow-up on unknown chromatographic peaks,failing impurity results not reported,no or inadequate training, responsibilities of quality control unit not in writing,inadequate cleaning and maintenance of equipment,no or inadequate failure investigation
主要错误：电子审计追踪未复核，电子审计追踪不能识别谁作了修改。没有计算机自动暂停，操作员和主管可以删除原始数据，没有复核合同实验室过来的数据，已建立方法的适当的功能在方法修改后未经确认，没有继续跟进未知色谱峰，没有报告不合格的杂质结果，没有培训或培训不够，没有写明质控的职责，设备清洁和维护不够，没有故障调查或调查不够?Examples:
事例：
-Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records are instituted only by authorized personnel
没有对计算机系统或相关系统进行适当控制以确保只有经过授权的人才能制定主生产记录-The audit trail generated within xxx does not truly reflect the identity of the responsible individuals.Individuals have been able to log on to the system under an other individuals account and make changes which then show up on the audit trail to the first individual.
在xxx产生的电子审计追踪不能真实反应责任人的身份。个人可以用其他人的账号登陆系统并作修改，电子审计追踪显示的是其他人作了修改。
-Changes made by PERSON1are attributed to PERSON2on the(electronic)audit trail.
第一个人作的修改在审计追踪上归于第二个人
-The firm's review of laboratory data does not include the audit trail/revision history to determine if unapproved changes have been made.
公司实验室数据的复核没有包括用来决定是否有未经批准的变更的审计追踪/版本历史。
-The xxx system computers in the lab do not time-out.If an employee fails to log off a computer and walks away other individuals can easily access the computer under the first employees account.
实验室中的Xxx系统计算机不能自动暂停，如果一个员工没有退出计算机就走开的话，其他员工可以很容易地用第一个员工的账户进入计算机。
-The firm routinely assigned method validation chemists,lead chemist,and laboratory supervisors system administrator status with the ability to modify and delete raw data files in the HPLC data acquisition system
在HPLC数据获取系统中，公司已经验证的方法，分析人员，主分析师，实验室主管和系统管理员能够修改和删除原始数据文件。
-Records maintained of any modifications of an established method employed in testing do not include the data to verify that the modification produced results that are at least as accurate and reliable for the material being tested as the established method
在测试中使用的修改后方法的记录没有包括用来确认修改方法至少能产生和原有方法同样精确和可靠结果的数据。
-The firm does not receive and review all raw data from contract testing laboratories
公司没有收到和复核来自合同实验室的所有数据。
-The accuracy,sensitivity,specificity,and reproducibility of test methods have not been established and documented
检测方法的精确性，灵敏度，专属性和重复性未经验证并记录
-The firm failed to perform finished product test method transfers for34products
34个产品的成品检测方法转移没有进行
-The firm has failed to perform method validations,method verifications,or method transfers for any of the laboratory test methods used to test active pharmaceutical ingredients
公司没有对用来检测APIs的所有实验室方法进行方法验证，确认或转移。
W-186
Keywords:Method validation,method transfer,process control procedure,sampling plans,test procedures
关键词：方法验证，方法转移，过程控制程序，取样计划，检测程序
?Primary deviations:Analytical methods transferred without method transfer or revalidation protocol,no or inadequate product specifications,no or inadequate sampling plans.
主要错误：分析方法转移时无转移或再验证草案。没有产品规格或不全，没有取样计划或不合适
?Examples:
事例：
-Failure to establish production and process control procedures designed to assure your drug products have the required identity,strength,quality and purity.For example,the validation protocols for xxx and xxx do not provide assurance that the manufacturing process quality throughout the production process
没有建立生产和过程控制程序以保证药品符合同一性，强度，质量和纯度方面的要求。例如：xxx和xxx的验证草案不能保证整个生产过程的生产质量
-failure to establish scientifically sound and appropriate specifications,standards,sampling plans, and test procedure designed to assure products conform to appropriate standards of identity, strength,quality,and purity.For example,there is no scientific justification for testing30capsules for content uniformity during process validation.
没有建立听起来很科学很合适的规格，标准，取样计划和测试程序以保证药品符合同一性，强度，质量和纯度方面的要求。例如：在验证过程中检测30个胶囊的装量差异没有科学依
据。
Failure to establish and document the accuracy,sensitivity and reproducibility of test methods employed.for example,methods that were validated at one facility and transferred to xxx site are being used without method transfer or revalidation protocol,.
没有记录所采用方法的精确度，灵敏度和重复性。例如：在一个地点验证的方法转移到另一个地点时，没有进行方法转移或者再验证方案。
W-185
Keywords:Software and computer system validation,back-up,limited access,audit trail,data encryption,accurate copies
关键词：软件和计算机系统验证，备份，限制登陆，审计追踪，数据加密，精确拷贝?Primary deviations:Inadequate storage and back-up,missing ability to discern invalid or altered electronic records,access to computer records without unique user ID and password,no or inadequate validation,inaccurate copies of electronic records.
主要错误：不适当的存储和备份，不能辨别无效或改编的电子记录，没有个人专用的用户名和密码来访问计算机记录。电子记录拷贝不准确
?Examples:
事例
-Failure to store records so as to minimize deterioration,prevent loss and back up of automated data processing systems
没有存储记录来最小化毁坏风险，预防丢失和数据自动处理系统的备份。
-The electronic data did not correlate with the paper records;you had not established an electronic data back-up procedure;and finally,data was copied onto the server from one system to the next via floppy:therefore,no limited access or data protection had been established
电子数据与纸面记录不相关联，你们没有建立电子数据备份程序，数据从一个系统到另一系统的拷贝非常松散,所以没有限制登陆和保护数据。
Failed to encrypt and/or physically secure your data back-up system to comply with the requirements to prevent deterioration or deletion of the analyzer data
没有给数据备份系统加密或物理保护以符合预防分析数据被毁坏和删除的要求。
-Failure to adequately validate the intended use of this PC and its software
没有充分验证计算机和软件的计划用途
-The dedicated PC[redacted]attached to the[redacted]was not secure in that access to the data on[redacted]was not granted by a unique username and password or equivalent method
计算机上用于编写的功能在访问数据方面不安全，不是通过个人专用的用户名和密码或同等的方法。
-there as no documentation associated with the electronic data for whom was responsible for collection of the analytical results as several quality control personnel have access to the [redacted]no software changes in the study data could be detected as there was no audit trail capability;and finally,the electronic data did not correlate with the paper records.
没有与电子记录相关联的谁负责收集分析结果和几个质量控制人员能够编辑的文件。在研究数据中没有软件变化可以被检测出，即没有审计追踪能力，最后电子数据与纸面记录不相关联。
-your response and have concluded that it is inadequate because no system validation was conducted to ensure accuracy,reliability,consistent intended performance,and the ability to discern invalid or altered records
你们已经做出系统验证不充分的结论，因为系统验证没有确保精确性，可靠性，持续使用能力和识别无效及更改记录的能力
W-184
Keywords:IRB,clinical investigations,review procedures
关键词：IRB，临床研究，复核程序
?Primary deviations:Failure to follow required written procedures,failure to use expedited review procedures.
主要错误：没有遵循已定规程，没有采用官方的复核程序
?Examples:
事例：
-Review of the inspection report indicates that the IRB failed to follow written procedures for conducting initial and continuing review of research
检查报告复核显示IRB没有遵循已定规程对研究进行起始复核和持续复核。
-The IRB's written procedures state that"the IRB shall consist of thirteen(13)members." Since October12,2005,the IRB membership roster has listed only12members.
IRB已定规程声明：IRB有十三个成员，但自从2005年10月12号开始，IRB成员表上只列了12个成员。
-The IRB's written procedures state that"meetings will be held on an as-needed basis,but no less than quarterly."However,the IRB records indicate that the IRB has met at intervals greater than three months on four occasions since August2004.
IRB已定规程声明：会议按需召开，但不少于每季度一次，IRB记录表明IRB从2004年8月以来有四次会议间隔在三个月以上。
-Failure to use expedited review procedures only for certain kinds of research involving no more than minimal risk or for minor changes in approved research[21CFR56.110]
在批准的研究中，只应用官方复核程序于几种包括不大于最小风险的研究和较小变更时错误的。
-Failure to ensure that the IRB reviewed proposed research at convened meetings at which a majority of the members of the IRB were present
没有保证在大多数IRB出席的召集会议上复核提议过的研究
W-183
Keywords:Clinical trials,investigational plan,investigator agreement
关键词：临床试验，调查计划，调查人员协议
?Primary deviations:Missing records,inaccurate data corrected,unapproved deviation from investigational plan,no or inadequate
主要错误:数据丢失，不准确的数据修正，调查计划中未经批准的偏差。(原文缺失)?Examples:
事例：
-Failure to ensure adequate monitoring of the investigation
未能保证对调查进行足够的监控
-Data were missing and inaccurate data was corrected for Subject[redacted]
数据丢失，为了项目X进行了不准确的数据的数据修正
-Failure to secure the investigator's compliance with the signed investigator agreement,the investigational plan,applicable FDA regulations,and any other conditions of approval imposed by the reviewing IRB or FDA
不能保证调查人员符合签署的调查人员协议，调查计划，FDA法规和其他IRB或FDA发布的批准条件
-There are repeated deviations from the investigational plan,spanning several years,with no apparent steps taken to bring the clinical investigators into compliance,which indicates failure to ensure investigator compliance
调查计划中有重复的偏差存在，这些偏差分布在好几年内。没有采取明显的步骤使临床调查员符合规定，这表明不能保证临床调查员符合规定。
W-182
Keywords:Method validation,USP,standard methods,stability testing,method documentation, change control,OOS,batch records
关键词：方法验证，USP，标准方法，稳定性试验，方法文件化，变更控制，OOS，批记录?Primary deviations:Failure to validate changed USP standard methods,missing validation for stability indicating methods,insufficient documentation of test methods,insufficient documentation of changes,no follow-up of oos situations,failure to release products that do not meet USP requirements,incomplete batch records
主要错误：变更USP标准方法后未验证，稳定性方法没有验证，检验方法文件化程度不够，变更文件化程度不够，oos情况没有跟进，放行了不符合美国药典标准的产品，批记录不完整。
?Examples:
事例
-Your firm uses USP methods to analyze your products,but changes have been made to the USP methods and no validation has been performed.For example,for Migrazone Capsules,the USP uses three different wavelengths to analyze the three active ingredients.Your firm changed the method to use[redacted]of or all three actives and no validation of the new procedure was performed.
你们公司用美国药典方法分析产品，但你们对药典方法进行了改变且未验证。例如：Migrazone胶囊，美国药典用三种不同的波长分析三种不同的活性成分，你们改变了方法，并未验证改变后的方法。
-Failure to follow your firm's written stability testing program as required by21CFR 211.166(a)in that your firm has no validation data to demonstrate that the method used to analyze products for stability is capable of detecting degradation of the products
没有遵循你们公司已经制定的21CFR211.166要求的稳定性测试程序。你们没有验证数据能表明你们采用的分析稳定性试验样品的方法能够检测到产品的降解。
-Your firm lacks complete written methods that fully describe the procedures,equipment, parameters and specifications to be used in the analysis of individual products.
你们公司缺少完整的书面方法描述规程，设备，参数和规格用于分析单个产品
-Written instructions for analyzing products include cross outs and changes to the instructions without any documentation as to why these changes were made
用于指导产品分析的书面文件删除或表更没有文件化，也没有说明为什么会变更
-Review of chromatograms revealed that,in certain instances,out of specification results which were recorded on the chromatograms had no corresponding reference or raw data recorded in the official laboratory bound notebook.In these cases,the data was recorded in the notebook only when the sample was retested and results found to be within limits.For example...
复核色谱图发现，在有些情况下，记录在色谱图上的OOS没有相应的参照。有的OOS纪录
在实验室笔记本上。在这种情况下，只有复检并且复检结果合格，数据才会被记在记录本上。
-Your firm has released products purporting to meet USP requirements when,in certain cases, they fail to meet such requirements.For example...
-Laboratory control results are not included in batch records as required by21CFR211.188(b)(5). Analytical results are only maintained in laboratory notebooks
你们放行的声明符合美国药典要求的产品，有些时候并不符合。例如：实验室记录没有按照21CFR211.188(b)(5)要求放在批记录中，分析结果保留在实验室记录本上。
W-181
Keywords:Cleaning records,sampling plans,test procedures,building design
关键词：清洁记录，取样计划，检验程序，建筑设计
?Primary deviations:Failure to keep records for the maintenance,cleaning,and sanitizing of equipment.Failure to establish sampling plans,test procedures,or laboratory control for testing your finished product Failure to have adequate building design.
主要错误：没有保存设备的维护，清洁和消毒记录，没有建立取样计划，检验程序或检验最终产品的实验室控制机制，没有进行合适的建筑设计
?Examples:
事例：
-For example,your firm lacked an adequate assessment of the cross-contamination risks posed by the manufacture of several potent compounds(e.g.cytotoxic and hormone products,as well as other products of high pharmacologic activity)at your facility.
-Failure to have adequate building design and construction used in manufacture,processing, packing,or holding of drug products to facilitate cleaning,maintenance,and proper operations
例如，你们公司没有评估在你们工厂生产几种化合物可能引起的交叉污染风险（比如：细胞毒素，激素或其他高药物活性产品）
-There were no equipment cleaning records for several of the product contact,multi-use formulation mixing rods.The investigators observed that there was no evidence to demonstrate that the mixing rods were dedicated to specific products.
与几种产品接触的多用混合棒没有设备清洁记录。检查员发现没有证据表明该混合棒是专用的
-Investigators observed black colored particles in at least one evacuated sterile vial.The microbiologist performing sterility testing on the vials was observed removing the vial with the black colored particles and replacing the vial.No sampling plan or test procedures were available to justify replacement of the finished product evacuated vial.
检察员发现至少有一个真空瓶上有黑色颗粒，进行无菌检验的微生物检验人员移动了有黑色颗粒的真空瓶，并用另一个瓶子替代。取样计划或检验规程不能证明该真空瓶的替代是正当的
W-180
Keywords:Cleaning validation,quality control unit,failure investigation,oos,raw data, laboratory notebooks,input-output checking,retesting
关键词：清洁验证，质量控制，失败调查，oos，原始数据，实验室记录本，输入输出检查，复检
?Primary deviations:Inadequate cleaning validation,quality control units failed adequate investigation,no or inadequate failure investigation,raw data not documented in laboratory
notebooks,oos retesting without supervisory approval,electronic data files not routinely checked for accuracy,discrepancies in electronic data
主要错误：清洁验证不当，质量控制检查不够，失败调查不够或没有，原始数据没有记录在实验室记录本上，oos复检没有监督批准，电子数据文件没有例行检查准确性，电子数据有矛盾
Examples:
事例：
-Our investigators observed numerous instances where the quality control unit failed to adequately investigate and resolve laboratory deviations and out-of-specification test results involving drug products that ultimately were released for distribution into interstate commerce
我们的检查员发现大量的例子：质量控制部门没有充分地调查和解决实验室偏差和检验跨国分销的药品时出现的oos
-Our investigators uncovered out-of-specification test results in laboratory raw data that were not documented in laboratory notebooks,and found that products were released based on retesting without any justification for discarding the initial out-of-specification test results.
我们的检查员发现实验室原始数据oos结果没有记录在实验室记录本上。产品放行是基于复测结果，没有任何理由地舍弃了原来的oos结果
-The chromatographic test data reflecting the out-of-specification test results were not recorded in laboratory notebooks.Instead,a new sample preparation was injected within the same chromatographic run without supervisory approval,as required by your firm's SOP
出现oos结果的色谱检测数据没有记录在实验室记录本上。而是在没有主管批准的情况下制备了新的样品并检测，这部符合公司sop的要求
-A review of the laboratory notebook shows the sample dilution value in the laboratory notebook was overwritten,without being signed and dated.
复核实验室记录本发现样品稀释值改写时没有签名和日期
-There was a failure to check for accuracy the inputs to and outputs from the"Total Chrom Data Acquisition System,"which is used to run your firm's HPLC instruments during analysis of drug products.For example,electronic data files were not routinely checked for accuracy and,as mentioned in the above observations,our investigators found numerous discrepancies between the electronic data files and documentation in laboratory notebook.
没有检查色谱数据采集系统输入输出的准确度，这个系统是用来运行分析药品的HPLC设备的。例如：电子数据文档没有例行检查精确度，在上述缺陷中，检查人员发现电子数据与纸面文件有很多矛盾的地方
W-179
Keywords:Computer validation,training,document control,CAPA,root cause
关键词：计算机验证，培训，文件控制，CAPA，根本原因
?Primary deviations:Computer systems nor validated,training needs not identified,failure to follow document controls requirements,no or inadequate CAPA procedures,no validation or verification that implemented CAPA activities are effective
主要错误：计算机系统没有验证，培训需求没有确定，没有遵循文件控制要求，CAPA程序没有或不充分，没有验证或确认采取的CAPA措施是有效的
?Examples:
事例：
-Failure to establish and maintain procedures for implementing corrective and preventive actions.
The procedures must include verifying or validating the corrective.and preventive actions to ensure that such actions are effective and do not adversely affect the finished device,as required by...
没能建立和维护实施CAPA措施的程序，程序必须包括确认或验证CAPA措施以保证措施有效和对成品设备造成相反的影响
-Failure to investigate the cause of nonconformities relating to product,processes,and the quality system,as required by21CFR820.100a)(2).For example,the following procedures, Complaint Handling,Defect Tracking and Trending,Nonconforming Material and Repair of Equipment,do not include procedures for performing failure investigations.
没有象21CFR820.100a)(2).要求的那样调查与产品，工艺和质量系统相关的不一致的原因
-Failure to have production and process controls for automated processes,as required by21CFR 820.70(i).when computers or automated data processing systems are used as part of production or the quality system.A manufacturer is required to validate computer software for its intended use according to an established protocol.For example,databases that are maintained for data analysis and other tracking and trending functions,including complaint and services access databases,have not been validated for their intended use.
当计算机或自动数据处理系统用于生产或质量系统时没有按照21CFR820.70(i)要求对自动化过程没有过程控制，生产商需要按照指定的草案验证计算机软件符合计划使用目的。例如：没有验证用于数据分析，追踪和趋势分析功能的数据库（包括投诉和服务数据库）符合计划使用目的
-Verification or validation of CAPA is required and no documentation was attached or referenced to CAPA440C.
需要确认和验证CAPA措施，CAPA440C没有附件或参照
W-178
Keywords:Ongoing equipment qualification(PQ),procedures,PQ,training,quality control unit, records,failure investigation
关键词：进行中的设备确认，程序，性能确认，培训，质量控制，记录，失败调查?Primary deviations:No or inadequate performance qualification,no or inadequate written procedures for production and process control,no or inadequate quality control unit,failure to perform investigation,no or inadequate training,procedures not followed,failure to maintain complete equipment calibration records
主要错误：没有或性能确认不当，没有或书面生产控制程序不当，没有或质量控制不当，没有进行调查，没有培训或培训不够，不遵循规程，没有保存完整的校验记录?Examples:
事例：
-Failure to routinely calibrate,inspect,or check automatic,mechanical,or electronic equipment according to a written program designed to assure proper performance[21CFR211.68(a)].
没有根据用来保证合适的设备性能的书面程序例行校验，检查，核对自动，机械或电子设备。-Specifically,your cryogenic pumping system lacks qualification according to a written plan to assure all parts of the system,including the pump,power supply,electric components,vacuum hold and cryogenic jacket,will operate properly for their intended use every time.
特别是你们的冷冻系统缺乏根据书面计划的确认，这个确认是为了保证包括泵，电力供应，电子元件，真空阀和冷冻夹套在内的整个系统能够每次都能正确地按计划使用目的运行
-Failure to establish adequate written procedures for production and process control designed to assure drug products have the identity,strength,quality and purity they purport or are represented to possess
没有建立充分的生产和过程控制程序以保证生产的药品具有声称的统一性，强度，质量和纯度
-Failure to establish an adequate quality control unit having the responsibility and authority to approve or reject all drug products,and the authority to review production records to assure no errors have occurred or,if errors have occurred,they have been fully investigated,as required by 21CFR211.22(a).Specifically.......
没有象21CFR211.22(a)要求的那样建立一个适当的有放行和拒收药品的责任和权利以及审核批记录权利确保没有错误发生，即使有错误，也会调查权利的质量控制部门
-Quality control unit personnel failed to perform an investigation into the failure of the filling equipment to fully pressurize the cylinders during a filling operation,in violation of21CFR 211.192
质量控制部门在一次填充设备增压充填柱操作错误时没有进行调查，这违反了21CFR 211.192
-Failure to maintain complete records of the periodic calibration of laboratory instruments required by21CFR211.160(b)(4)and211.194(d)
没有按照21CFR211.160(b)(4)a和211.194(d)要求保存完整的阶段性校验记录。
W-177
Keywords:Bioequivalence,retrospective review of study data,analytical methods,no procedures,pharmacokinetic profiles,failure investigations
关键词：生物等效性，研究数据回顾性复核，分析方法，没有规程，药代动力学特征，失败调查
?Primary deviations:invalid retrospective review of study data,inadequate documentation to demonstrate accuracy of analytical methods,providing incorrect information to the FDA,missing studies in retrospective review,lacking procedures for critical steps in retrospective review,failure to investigate pharmacokinetic profiles with unexpected concentration results,no timely information of study sponsors about invalid data.
主要错误：无效的研究数据回顾性复核，论证分析方法准确度的文件不充分，提供给FDA 不正确的信息，缺少回顾性复核研究，缺少回顾性复核关键步骤的程序，没有调查出现预料外的浓度结果的药物动力学特征，没有研究人员关于无效数据的局势信息
?Examples:
事例
-Failure to demonstrate that the five year retrospective review is effective and capable of discriminating between valid and invalid data
不能证明5年的回顾性复核有效，也不能识别有效数据和无效数据
-Failure to assure that the analytical methods used for in vivo bioavailability studies could accurately measure the actual concentration of active drug ingredient,or its metabolite,achieved in the body."Long term use"is not a sufficient assurance of assay accuracy.
不能保证用于分析生物利用度研究的方法能精确测量身体内的活性药物组分或它的代谢物的实际浓度。长期采用这种方法并不足以保证含量检测的精确性
-For these reasons you have not demonstrated that the reported concentration results in Study xxx are accurate.
由于这些原因，你们没有证明在xxx研究中的浓度结果是准确的
-You provided incorrect information to FDA regarding the status of undergoing retrospective review
你们提供给FDA关于回顾性复核状态的信息不正确
-You failed to appropriately include studies in the retrospective review
在回顾性复核中你们没有包含适当的研究
-There is no assurance that reviews were conducted in accordance with original or revised procedures
没有保证复核是根据原始或修改的规程进行的
-You failed to investigate the cause of anomalous results,or re-assay the affected samples. Contrary to your response,the frequency of occurrence is not a justification for accepting anomalous study results
你们没有调查异常结果或重新重检验受影响的产品。与你们的回答相反，经常发生异常研究结果不是接受这种结果的理由。
-Although you discontinued use of the xxx method in August2005,you failed to inform study sponsors that the data generated with this method was invalid.
尽管你们在2005年8月不再使用某方法，但你们没有告知研究人员这种方法产生的数据是无效的
W-176
Keywords:Clinical studies,subjects safety,subject rights,supervision of personnel,signatures, review reports,record maintenance
关键词：临床研究，实验体安全，实验体权利，个人监督，签名，复核报告，记录保存?Primary deviations:failure to protect the rights,safety,and welfare of subjects under care, failure to personally conduct or adequately supervise the above references clinical trial,no evidence of lab report review,failure ton conduct the study in accordance with the investigational plan,failure to prepare and maintain adequate and accurate records,failure to promptly report to the sponsor any adverse effect that may reasonably be regarded as caused by,or probably cause by,the drug.
主要错误：不能保护实验体权利，安全和福利。没有亲自进行或充分监督临床试验，没有证据表明复核了实验室报告，没有按照调查计划进行研究，没有准备和保留充分、准确的纪录，没有迅速向研究发起人报告
?Examples:
事例：
-You did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations
你们没有坚持法规和FDA规则来进行临床研究
-Because this subject had a history of peptic ulcer disease and an incident of gastrointestinal bleeding she was at substantial risk for GI bleed related to treatment with aspirin.
实验体有胃溃疡病史且在用阿司匹林治疗时发生过非常危险的胃肠出血事故
-The record does reflect that you reviewed the subject screening assessments and related subject records in accordance with the protocol
记录不能反映你们复核过对实验体的评估以及根据草案的一些实验体记录
-You delegated certain study tasks to an individual not qualified to perform such tasks
你们委托没有资质的人进行某些研究任务
-You permitted an individual with no medical training to evaluate laboratory results for clinical significance.The lab reports were not co-signed by you,therefore thee is no indication that you reviewed them
你们允许未经医学培训的人评估临床实验数据。实验室报告你们没有联合署名，所以不能表明你们复核了该报告。
-The case history did not contain any other documents to validate the subject's enrollment and completion of clinical investigation
没有证明临床研究实验体招收和完成的历史文件
W-175
Keywords:Process validation,software validation,design verification,SOPs,incoming product control,complaint handling
关键词：工艺验证，软件验证，设计确认，SOPs，来料控制，投诉处理
?Primary deviations:Inadequate procedures for monitoring and control of parameters for validated processes,inadequate process control procedures,inadequate procedures for incoming product control and documentation,inadequate complaint handling procedures,no or inadequate software
主要错误：工艺验证的参数监测和控制规程不够，过程控制规程够，来料控制和文件化规程够，投诉处理规程够，没有软件或不够
?Examples:
事例
-Failure to establish,and maintain procedures for monitoring and control of parameters for validated processes to ensure that the specified requirements continue to be met
工艺验证的参数监测和控制规程没有建立或维持，这不能保证能持续满足特殊的参数要求-Where the process cannot be fully verified by subsequent inspection and test,the process shall be validated with a high degree of assurance and approved according to established procedures.通过后来的检查和检测发现工艺未经完全的确认，工艺必须按照批准的规程高确认度地验证-The validation activities and results,including the date and signature of the individual(s) approving the validation and where appropriate the major equipment validated,must be documented.For example,your firm has not validated the software used in the xxx device.The xxx device has a microprocessor programmed with specific-software to control the xxx and alternate the xxx Procedures for validating the device design to ensure that the device conforms to defined user needs and intended uses have not been provided,nor has the software validation been performed
验证的行为和结果包括批准验证的个人签名以及验证的主要设备必须文件化。例如：你们公司未能验证在某设备中使用的软件。某设备有带特殊软件的微处理器，能够控制和改变参数。不能提供保证该设备设计符合特定用户需要和预期使用目的验证规程，也没有对软件进行验证
-Failure to establish and maintain process control procedures,including documented instructions, standard operating procedures(SOPs),and methods,that define and control the manner of production
没有建立和维护过程控制规程，包括定义和控制生产方式的说明文件，标准操作规程和方法-Failure to establish and maintain procedures for finished device acceptance to ensure that each production run,lot,or batch of finished devices meets acceptance criteria
没有建立和维护保证每个批次成品设备符合接收标准的设备接收程序
-Failure to establish and maintain procedures for acceptance of incoming product,including documentation of acceptance or rejection
没有建立和维护过程来料接收规程，包括接收和拒收的记录。
-Failure to establish and maintain adequate complaint handling procedures for receiving, reviewing,and evaluating complaints by a formally designated unit
没有建立和维护适当的由指定的部门接收，复核和评估投诉的投诉处理程序
W-174
Keywords:CAPA,complaints,training,equipment calibration,process validation,received product testing
关键词：CAPA，投诉，培训，设备校验，工艺验证，
?Primary deviations:training procedures not implemented,no or inadequate procedures for equipment calibration and inspection,no procedures for process validation and monitoring,CAPA procedures not established and implemented,complaint files not maintained,specifications of all purchased or otherwise received products and services not verified
主要错误：没有实施培训程序，没有设备校验和检查程序或不充分，没有建立和实施CAPA 程序，没有保存投诉文件。没有确认所有购买或其它标准产品的规格和服务?Examples:
事例：
-Failure to establish,implement,and control procedures to ensure that equipment used in production and measuring are routinely calibrated,inspected,and checked for accuracy Specifically,no records are maintained for the inspection,checking,adjustment and calibration of scales,production furnace,and filling machine
没有建立，实施和控制保证用于生产及检测用的设备进行了例行校验，检查（特别是准确度检查）的规程，没有保存检查，核对，调整和校验天平，生产炉，填充机械的记录
-Failure to ensure complaint files are maintained and that all oral and written complaints are documented upon receipt and are processed in a uniform and timely manner
没有保证保存了所有的投诉文件，也没能保证所有口头和书面的投诉按照接到的时间记录及统一及时地进行处理
-Failure to establish,implement,and control procedures for the validation of production processes and control and monitoring of process parameters
没有建立，实施和控制生产工艺验证，生产参数控制和监控的规程
-Failure to implement and control procedures to ensure that all purchased or otherwise received product and services conform to specified requirements
没有实施和控制保证所有购买或其它标准产品的规格和服务符合特定要求的规程。
-Failure to establish,implement,and control procedures for Corrective Action and Preventive Action(CAPA)
没有建立，实施和控制CAPA规程
-Failure to ensure that training procedures identifying training needs are implemented and training activities are documented
不能保证培训程序能鉴别培训目的实现与否及培训活动被记录
W-173
Keywords:Audit of contract laboratories,certificate of analysis,responsibilities of quality unit,
reserve samples,API,repackaging,container closure systems,equivalency
关键词：合同实验室的审计，报告单，质量部门职责，留样，API，重新包装，密闭容器系统，等价
?Primary deviations:failure to conduct audits of contract laboratories,failure to validate the authenticity of suppliers COAs,reserve samples not retained,equivalency of container closure system not documented
主要错误：没有对合同实验室进行审计，未能证实供应商检验报告的真实性，未留样，没有文件证明容器密闭系统的等价性
?Examples:
事例：
-Failure to validate the authenticity of supplier's COAs of a periodic basis in lieu of full compendia testing of APIs that you package
定期按药典全检你们重新包装的API不能证实供应商检验报告的真实性
-Failure to conduct audits of contract laboratories that perform testing-of-incoming API.Your SOPs indicate that these audits are to be conducted every two years
没有对检验API的合同试验室进行审计，SOP显示审计每两年进行一次
-Failure to maintain written procedures that describe the responsibilities and procedures applicable to the quality control unit
没有书面规程描述质量控制职责。
-Failure to retain reserve samples of each batch of each API that you repackage.There were a number of instances your firm received complaints regarding product integrity.Your firm failed to conduct complete investigations into these complaints regarding the APIs that you repackage because no reserve samples were available to examine
你们重新包装的每个品种每一批的API都没有留样。你们公司接到大量的与产品同一性有关的投诉。对这些你们重新包装的API的投诉，你们没有进行全面调查，因为没有可用于检验的留样。
-You have not demonstrated that the container closure systems into which these APIs are repackaged are identical or equivalent to those in which the APIs are received
你们没有论证你们用于重新包装来料API的容器密闭系统与原先的一样或等效。
W-172
Keywords:failure investigations,contract laboratory,repair,passwords,audit trail,security, method change,signatures on test results,power failure
关键词：失败调查，合同实验室，修理，密码，审计追踪，安全性，方法变更，测试结果上的签名，电源故障
?Primary deviations:insufficient written records of failure investigations,investigations not extended to other batches,missing HPLC peak not investigated,no investigation regarding HPLC malfunctions requiring external repair,impact of power failure not investigated,laboratory records not signed by the analyst,analyst not identified,failure to use group passwords to log-on to computer systems,changes of methods by authorized persons not ensured,no review of audit trail,contract laboratory not qualified
主要错误：失败调查的书面记录不够，调查没有延伸到其他批次，HPLC缺峰没有调查，HPLC 失灵需要外部维修没有调查，电源故障的影响没有调查，分析人员没有在记录上签字，不能识别分析人员，使用团体密码登陆计算机系统不正确不能保证由经授权的人变更方法，没有
审计追踪复核，合同实验室没有确认
?Examples:
事例：
-Written records are not always made of investigations into unexplained discrepancies,nor did investigations of unexplained discrepancies extend to other batches of the same drug product or other drug products that may have been associated with the specific failure or discrepancies
书面记录不能解释调查的莫名其妙的矛盾，莫名其妙矛盾的调查没有延伸到同样药品的其他批次或与特殊失败或矛盾相关的批次
-The reference standard injection following assay and content uniformity testing of xxx,failed to show any peaks due to a leaking column.There was no documented investigation of this deviation,there was no assessment of the impact of the leaking column on the xxx analysis or any other analysis conducted with the same column,and the observation was made during the previous inspection,yet no investigation was conducted.
在检验某种药品含量和装量同一性测试中，由于柱泄漏，参照标准品图谱没有任何峰，没有评估分析柱泄漏对这次分析及用这根柱做的其他分析产生的影响，上次检查中也存在这个缺陷，仍然未作任何调查。
-There was no documented investigation regarding HPLC malfunctions requiring external repair. Both HPLC xxx and xxx required repair in June2005;however there is no documentation regarding whether the malfunctions impacted any analyses,and if so,what the corrective actions were regarding those analyses.
没有需要外部修理的HPLC故障情况的书面调查，2005年六月两台HPLC需要修理，然而没有故障是否影响了哪些检测的，以及如果影响了，采取怎样的纠正措施的书面文件
-Power failures occurred during analyses of xxx.Investigations did not document the impact on the analyses,any re-testing or resampling,or if the power outage impacted any other analyses
在分析xxx时，发生电源故障。没有调查队对分析，重新检测，重新取样或对其他分析的影响。
-Laboratory records fail to include the initials or signature of the person who performs each laboratory test[21CFR§211.194(a)(7)].Specifically,laboratory analysis records for analyses performed on HPLC xxx and xxx do not indicate which analyst performed the injections.
没有按照[21CFR§211.194(a)(7)]要求在实验室记录上签分析人员的首字母或签名，特别是进行xxx和xxx HPLC检验时，实验室记录不能显示是谁进的样。
-Failure to maintain complete records of any modification of an established method employed in testing[21CFR§211.194(b)].Specifically,the records of laboratory methods stored in the xxx computer system do not include the identity of the person initiating method changes.
没有按照[21CFR§211.194(b)]要求保存任何改变采用分析方法的记录。特别是储存在计算机系统中方法的记录不能识别是谁开始变更方法的
-Appropriate controls are not exercised over computers or related systems to assure that changes in analytical methods or other control records are instituted only by authorized personnel
没有对计算机或相关系统进行合适的控制以确保分析方法或其它控制记录的变更只能由经授权的人进行
-Laboratory managers(QC and R&D)gained access to the xxx computer system through a common password.Analysts were not required to use individual passwords;they operated the system following the login by the laboratory managers.
实验室经理（QC和R&D）可以通过公共密码进入某计算机系统。没有要求分析人员使用个人密码，分析人员在实验室经理登陆后操作系统。
-Due to the common password and lack of varying security levels,any analyst or manager has access to,and can modify any HPLC analytical method or record.Furthermore,review of audit trails is not required.
由于公共密码和缺少不同的安全等级，分析人员和精力都能访问和改变HPLC分析方法和记录，并且没有要求对审计跟踪进行复核
-Failure to follow written procedures applicable to the quality control,unit[21CFR§211.22(d)]. Specifically,the contracted laboratories responsible for performing analyses on Active Pharmaceutical Ingredients and other drug components,used in the finished drug products,such as LOD,nitrogen content;microbial limits,and specific rotation,have not been qualified by the quality unit as per your firm's written procedures.
没有按照[21CFR§211.22(d)]要求遵循应用于质量控制的书面程序。特别是，负责分析用于制剂的API和其他药物组分（干燥失重，氮含量，微生物限度，比旋的合同实验室）没有按照你们公司的书面规程被质量部门确认
W-171
Keywords:Complaints,service,repair,design,risk assessment
关键词：投诉，服务，修理，设计，风险评估
?Primary deviations:Service records not maintained,inadequate handling of complaints,not all possible risks identified and documented
主要错误：服务纪录没有保存，投诉处理不充分，不是所有可能发生的风险都被识别并记录?Examples:
事例：
-Failure to establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and documented
没有建立或维护规程以确保设备的设计要求是适当的并被记录
-Your firm failed to identify,approve,and document appropriate design inputs prior to the start of its formal design of the Frye Adjusting Instrument
你们公司没有在开始正式设计Frye调整设备之前确定，批准和记录适当的设计输入
-Failure to establish and maintain procedures for validating the device design to ensure that the device conforms to user needs and intended uses
没有建立或维护设备设计验证方面的规程以确保设备符合用户要求和预期使用目的
-Your firm failed to adequately identify and document all possible risks associated with your device and document the results of your firm's risk analysis
你们没有充分识别和记录与设备相关的可能存在的风险，也没有记录你们风险分析的结果-Failure to establish and maintain complaint handling procedures for receiving,reviewing, evaluating,and documenting complaints by a formally designated unit
没有建立和维护正式指定部门接收，回顾，评估和记录投诉的投诉处理程序
-Failure to maintain service reports for serviced devices,as required by21CFR§820.200(d).For example,your firm failed to maintain service reports for each device returned to your firm for servicing or repair(e.g.the name of the device,the date of service,the individual(s)servicing the device,the service performed,and the test and inspection data).
没有按照21CFR§820.200(d)要求保存设备的维修报告。例如：你们没有保留每个送回公司维修或修补的设备的维修报告（比如：设备名称，维修日期，维修人，进行了什么维修以及
测试和检查数据
-Your firm failed to document the results of its analysis or evaluation of emails of complaints and service reports in order to identify existing and potential causes of nonconforming product.You stated that you mentally evaluated complaints and servicing or repairs of returned devices but that you had not documented any evaluations.
你们公司没有记录投诉邮件的分析或评估结果和维修报告以便于确定不合格产品出现的已有或潜在原因。你们声称你们内心评估过投诉和送回设备的维修或修补，但你们没有任何评估的文件
W-170
Keywords:process control,change control,training,product identification
关键词：过程控制，变更，培训，产品鉴别
?Primary deviations:no adequate production and process controls,inadequate change control, no performance verification after the change,missing records of communication,training not documented
主要错误：没有足够的生产和过程控制，不适当的变更，变更后没有进行执行评估，缺少通讯纪录，培训没有文件化
?Examples:
事例：
-Failure to establish and maintain adequate production and process controls that include documented instructions,standard operating procedures(SOP),and methods that define and control the manner of production
没有建立和维护包括文件化的说明，标准操作规程和定义及控制生产方式的方法在内的足够的生产和过程控制。
-Failure to establish and maintain procedures for changes to a specification,method,process,or procedure,including verification or validation of such changes
对于规格，方法，工艺或规程的变更以及这些变更的确认或验证，没有建立和维护程序。-Failure to promptly remove obsolete documents from all points of use
没有及时从所有使用点拿走旧文件。
-Your firm changed the xxx Cooler-Heater device's internal timer setting in two instances. The reason for the changes,the review and approval for the changes,and the effective date of the changes were not documented
你们公司改变了冷却加热器内部里两个地方的时间设定。变更的理由，审核和批准以及变更实施日期都没有记录。
-Your firm failed to conduct,document,and maintain the results of the verification testing of each change o determine whether or not each change affect operations and performance specifications
你们公司没有管理，记录和维护每个变更的确认测试结果以确定变更是否影响操作和性能规格。
-Your firm failed to maintain records of communication with the specification developer to document who initiated and authorized the changes,the signature of the approving individual(s), the approval date,and an effective date of each approved change
你们公司没能保留与规格开发者的通讯记录以记录谁发起和批准了变更，批准人的签名，批准日期和批准变更的生效期。