QualityManagementSystemManual Doc.No.G5500Rev.11Status:APPROVEDEffective:09/07/2017Page7of32 TheQMSdocumentationincludes: a.adocumentedqualitypolicyandobjectives; b.qualitymanual; c.documentedproceduresrequiredbyISO13485:2016and21CFRPart820,asapplicable; ...
andinsteadincorporatebyreferencethe2016editionoftheInternationalOrganizationforStandardization(ISO) 13485,Medicaldevices-Qualitymanagementsystemsforregulatorypurposes,inpart820.Asstatedinthatproposed rule,therequirementsinISO13485are,whentakenintotality,substantiallysimilartotherequirementsofthecurrent ...
6.1.1 Controlled Terminologies 受控术语Controlled terminology standards are an important component of study data standardization and are a critical component of achieving semantically interoperable data exchange (See Appendix A). Generally, controlled terminology standards specify the key concepts that are rep...
需要金币:*** 金币(10金币=人民币1元) 美国FDA 指导原则 C反应蛋白(CRP)、高敏C反应蛋白(HsCRP)和心脏C反应分析的评审标准(PDF格式) 英文原版.pdf 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 Guidance for Industry and FDA Staff Review Criteria for Assessment of C-Reactive Protein ...
This manual was written to reduce compendia method ambiguity and increase standardization between ORS laboratories. By providing clearer instructions to ORS labs, greater transparency can be provided to both industry and the public. 本手册旨在减少药典方法的歧义并提高ORS 实验室之间的标准化。通过向ORS ...
We defined “surgical robot” according to the International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) definitions in ISO 8373, IEC 80601-2-77, and IEC 60601-4-1 as medical electrical equipment with a degree of autonomy that incorporates a computer-...
Your firm failed to have appropriate procedures for the integration of chromatographic peaks and for the review of chromatographic data.贵公司未能制定适当的色谱峰积分和色谱数据审查程序。 Our inspection team identified examples of your analysts entering manual integration events that yielded passing results...
General considerations include a standardization of evaluations to ensure reliability; a plan for community acceptance and inclusivity; engagement of key stakeholders to identify clinically meaningful outcomes and to assess the acceptability and feasibility of the study design; planning to keep families engag...
Laboratory records do not include complete records of any testing and standardization of laboratory reference standards. 实验室记录未包含实验室对照品的任何检验和标定的完整记录。 Specifically, reference standard lots have not been tested and shown to meet initial release criteria in applicable versions of...
The blood bank's SOP manual should list and describe recipient reactions it considers to be adverse, as well as the procedures to be followed for handling and investigating these reactions. Recipient reactions usually not considered serious include low fever and chills of short duration, hives, or...