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1、： FDA Warning Letters, Form 483 Observations and Establishment Inspection Reports PreviewFDA 警告文字，来自 483 观测资料和预先检查报告。Important: Warning letters and other FDA inspection documentation should be interpreted in the context of full content. Just looking at extracts may be misleading. And sometimes they
2、include good advice from the FDA not mentioned in the extracts. 重要性：警告文字和其他的重要性：警告文字和其他的 FDA 检查文件必须说明，根据上下文包括全部内容。检查文件必须说明，根据上下文包括全部内容。 仅是看摘录可能被误解。并且有时要包括从仅是看摘录可能被误解。并且有时要包括从 FDA 那里征求好的建议，而不是只那里征求好的建议，而不是只 提到摘录。提到摘录。FDA 483 Inspectional Observations, EIRs did not include a process capability challen
3、ge, did not ensure that the test equipment used was capable of functioning as necessary to capture results at both the high and low ends of the test specifications, and did not include challenges with known failures to ensure the equipment detected fault conditions事例：事例：-没有迹象表明你的公司进行定期检查或审计这些记录，来确保数
4、据的有效性。-缺乏建立和保持程序，这需要改正和预防措施的工具，这包括维修的分析程序，工作操作，让步，返修品，或其他的质量数据资源，以此来鉴别现在和潜在的不合格产品存在的原因，或其他质量问题，正如. D21 CFR 820.100(a)(1)-例如，确认工作站测试设备作为最后测试系统的一部分；不包括性能测试，不能保证过去的测试设备有能力发挥作用，来获得所有高 水平和低水平测试规格的结果，不包括熟知的错误，来确 保设备察觉错误情况。Warnin g Letter 警告信警告信W-146Keywords: risk analysis, design validation, change contro
5、l, software testing, acceptance criteria, quality control, installation qualification, inspection, supplier assessment 关键词：风险评估，设计确认，变更控制，软件测试，接受标准， 质量控制，安装控制，检查，厂商评估Primary deviations: no procedures for validating the device design, no formal risk analysis for software changes, no procedures for fi
6、nished device acceptance, inadequate installation, inadequate inspection, no procedures for supplier assessment. 主要错误：主要错误：没有装置设计的确认手续，对于软件变更没有正 式的风险评估，没有完成的可接受装置的程序，没有充分的 检查，供应商没有评估手续。Examples: - Failure to establish and maintain adequate procedures for validating the device design to ensure that t
7、he device conforms to user needs and intended uses and include risk analysis, as required by 21 CFR 820.30(g) (FDA 483, Item 151. 事例：事例：- For example, a formal risk analysis of the original system design and software changes to correct software bugs that caused incorrect functionality or performance
8、 problems, and to enhance the product, has not been documented. Although your software release notes briefly describe the nature of unresolved software bugs in a particular software version, they do not explain the impact of these software bugs on user needs and intended uses. For example, in the wo
9、rkflow release notes, dated 6/24/04, software version 2.Otr17 described that “the scores for the left eye and right eye was reversed, and the macular edema value used previously was confusing.“例如：一个对原始系统设计的正式的风险分析没有证明文件， 改变软件以修补那些会引起错误功能和行为的软件漏洞的行 为也没有文件证明，以及改变软件以增强生产的行为也没有 文件证明。虽然你的软件 - Status of d
10、esign changes was not documented to explain why certain Ddesign changes were not implemented to correct Software bugs- The “Workflow Release Notes by xxx has no status information or discussion of the test releases of software versions v2.xx36 through v2.xx40- Failure to establish and maintain proce
11、dures for finished device acceptance to ensure that each production run, lot, or batch of finished devices is not released for distribution until all the requirements are completed as required by 21 CFR 820.80(d) FDA 483 item 3. For example, your firm has not documented the signature(s) of approval
12、needed to release xxx for distribution- Failure to establish and maintain procedures for adequate installation and inspection, as required by 21 CFR 820.170(a) and document the installation activities and inspection results, as required by 21 CFR 820.170(b) FDA 483 Item 5. For example, your firms de
13、vice installation procedure was in the draft form at the time of our inspection, and your firm has not maintained records of installation activities and inspection results of the retinal image acquisition subsystem of the 3DT system at the clinical sites.- Failure to establish and maintain procedure
14、s to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50 FDA 483, Items 10, 11, 12, and 13). For example, your firm has not (a) evaluated the suppliers for their ability to meet your firms requirements; (b) defined the
15、quality requirements that each supplier must meet; (c) defined the frequency of supplier evaluations; and (d) documented supplier evaluations. Warning LetterW-145Keywords: part11, electronic records, electronic medical record (EMR) system, computer validation, audit trail, accurate and complete copi
16、es, invalid and altered records Primary deviations: missing documentation for validation and other part 11 requirements Examples: Our review of the inspection results also noted that you use an electronic medical record (EMR) system to maintain medical and other clinical data for your patients, including study subjects . You told Mr. xxx that data obtained during study visits are entered directly into the EMR, and no paper records are used. A follow-up letter from you t
