FDA警告信中的IT问题---第1部分：医疗器械（翻译：Julia）

巴西木

原文网址http://www.gmp-compliance.org/enews_04452_Current-FDA--39-s-Warning-Letters-on-IT-Topics---Part-1-Medical-Devices.html

GMP News
27/08/2014

Current FDA's Warning Letters on IT Topics - Part 1: Medical Devices

FDA警告信中的IT问题---第1部分：医疗器械

In a first stage of escalation - when serious GMP deviations are identified during inspections, or in case of insufficient corrective measures - the FDA issues a Warning Letter to the company concerned. Within 15 working days, the company in question has to redress the deviations with concrete action plans. If the Agency evaluates these action plans as insufficient, further escalation levels may follow.

在第一阶段----GMP检查过程中，如果发现严重的GMP偏差，或者纠正措施不充分---FDA会向相关的公司签发警告信。在15个工作日内，公司必须采取具体的纠正措施计划纠正问题。如果FDA经过评估认为纠正计划不充分，则其措施可能会升级。

Some Warning Letters from 2014 also list GMP deficiencies with regard to IT topics. Not a single Warning Letter has been exclusively issued just because of IT issues though. But taken together, all the GMP deviations in a company were so serious that the Agency issued a Warning Letter which also included deviations related to IT.

在2014年的一些警告信中，也列出了与IT相关的GMP缺陷，尽管并没有哪封警告信只单独针对IT问题发出，但汇总来看，公司里所有的GMP偏差太过严重，因此FDA签发的警告信中也包括了与IT相关的偏差。

All in all, 7 Warning Letters from 2014 contain topics with regard to IT. Four Warning Letters have been issued to manufacturers of medical devices, 2 Warning Letters to manufacturers of medicinal products and 1 Warning Letter to an API manufacturer.

总而言之，2014年有7封警告信包括了与IT相关的问题，其中4封签发给医疗器械的生产商，2封签发给医疗产品，1封发给原料药生产商。

IT-related Warning Letter regarding medical devices

医疗器械中与IT有关的警告信

IT-related Warning Letters to manufacturers of medical devices always refer to 21 CFR 820.70 (i) "Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70 (i)".

发给医疗器械生产商的与IT相关的警告信都是引用了21 CFR 820.70 (i)“当计算机或自动化数据处理系统用作生产或质量体系的一部分时，未能按CFR 820.70 (i)的要求，根据已拟定的方案来验证计算机软件适用于其既定用途”。

The Warning Letter issued for the company Cotton High Tech generally noticed that the company wasn't able any more to show that the (not further specified) system had been validated for the intended use. The Warning Letter for Instrumendreferred to a Software Operating System used to log, evaluate, and investigate complaints, incoming, in process, and finished non-conformances. It has be found that the validation didn't exclude the fact that records could be deleted by employees. The company's response was insufficient: the response did not include a validation report for the Sofware Operation System for restricting the deletion of complaints to the Heads of Quality. In addition, the Agency had been missing training records on revised procedures. The Warning Letter for the company HeartWare showed failures to maintain the own requirements for validation. A new test was implemented in July before the modified software was validated in September.

对COTTON HIGH TECH公司的警告信中泛泛提到公司不再能证明（没有进一步说明）其系统没有被被验证适用于其既定用途；对INSTRUMEND公司的警告信则指向了用于日常登记、评估和调查客诉、进料、中控和成品不符合情况的软件操作系统。FDA发现对该系统的验证未排除记录可以被员工删除的可能性。公司的回复不充分：回复没有包括软件操作系统中限制质量负责人删除客诉记录的验证报告。另外，没有提交对修订后程序的培训记录。对HEARTWARE公司的警告信显示其未能维护其验证要求。在对修改后的软件进行验证前（9月）即已实施了新的测试（7月）。

The company Steris Isomedix sterilises medical devices. It failed to take specific measures to ensure that computer errors do not generate the loss of dosimetric data. Over two years 2,900 records were missing and their (planned) loss couldn't be clearly identified. Although the company's response to the Warning Letter announced corrective actions to be taken, no documentation was included with the responses to verify these actions.

对STERIES ISOMEDI无菌器械公司的警告信中指出，其未能采取特定的措施来保证计算机错误不会产生剂量数据缺失。超过2年2900条记录缺失，且这些缺失都没有被清楚界定。尽管公司对警告信的回复宣称将采取纠正措施，但在回复中并没有提交任何文件记录来佐证这些措施。

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谢谢分享，对于计算级化系统的验证，还是一知半解。呵呵

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