验证生命周期和质量回顾
- 1、下载文档前请自行甄别文档内容的完整性，平台不提供额外的编辑、内容补充、找答案等附加服务。
- 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
- 3、如文档侵犯您的权益，请联系客服反馈,我们会尽快为您处理(人工客服工作时间：9:00-18:30)。
G lobal I ndustrial O perations
系统是否直接接触产品？
G lobal I ndustrial O perations
G lobal I ndustrial O perations
G lobal I ndustrial O perations G lobal I ndustrial O perations
4)来源于该组件的信息被记录在批记录中或其它GMP相关文件中
G lobal I ndustrial O perations
7)此组件用来建立和保持系统的关键状态
G lobal I ndustrial O perations
设计确认Design Qualification (DQ)
文件证明，设计标准涵盖所有的用户要求标准
Documented evidence to prove that the consideration of Design Specification fully covers User Requirements Specification
设计确认包括Design Qualification Activities:
准备DQ 核对单检查Produce a DQ check-list to check:•设计标准是按照用户要求纲要进行的DS against URB •评估供应商过程是按照设计标准进行的Supplier’s competency against DS
•准备IQ+OQ 方案IQ+OQ protocol preparation
32
Process/Stage
Function/Opera tion Identification of failure
Evaluation risk
Control
Measure
Validation of control measure
Residual Risk
Severity
Likelihood
Consequence
U
R S D S I Q
O Q
P Q
43
P r o c e s s U R S I O Q P Q 确认和研究风险可能性EM 建立可检测性
清洁
计划
降低可
能性
第6阶段－性能确认
Stage 6-Process Qualification
性能确认
Process Qualification
最终用户
End User Handover 验证批准
Validation Approval 第7阶段
To Stage 7
项目管理Project Management
Overview –Qualification Record
‘Baseline documents’& baseline
procedures
Number of documents depends
on system
Only update upon re‐
qualifcation
All original documents stored
under QA (Validation) function
–forms is a means of reference
only
Proposed changes are by CCF, or local SOPs
Provides a logic map on cause and effect; Every change requires an assessment of required
updates
Essential to support periodic review practices; central part of strategy on ‘Validation Life Cycle’
Each device that uses software / firmware is within scope
Scope can change over Validation Lifecycle
proof History
Issue is on ‘opening’instrument for maintenance
Each device that uses software / firmware is within scope Scope can change over Validation Lifecycle
Intended schedule of work
Unscheduled work i.e. breakdowns, repairs, Outcome of tamper‐evident label and
Specification
Base‐lining of requirements, either by system manuals and / or formal functional specification document Controls and records the progress on increasing
Traceability
Link to functional specification
Controls and records the progress on increasing capability