计算机化系统及CSV,DI培训课件
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8
确认与验证的区别
PIC/S系列定义
PIC/S Guidance to GMP for Medical Products Annexes 2015-10-01 Process Validation The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes. Cleaning Validation The gathering of evidence through chemical analysis after each batch/campaign to show that the residues of the previous product or cleaning agents have been reduced below the scientifically set maximum allowable carryover level.
中国 GMP计算机化系统附录-2015-12-01 计算机化系统由一系列硬件和软件组成，以满足特定的功能。
16
计算机系统和计算机化系统的区别
计算机化系统
实验室自动化
工艺自动化
控制仪器 纯信息系统 控制设备 数据汇总
IT基础架构
IT系统 业务流相关
19
计算机系统和计算机化系统的区别
20
审计追踪和系统日志的区别
计算机化系统及CSV,DI培训
1
内容
01/ GMP相关重点概念解析 02/ CSV基础架构确认 03/ GAMP 5基于风险的计算机化系统验证 04/ 系统验证状态保持及运维管理
4
1
5
1 确认与验证的区别
2 计算机系统和计算机化系统的区别
3 审计追踪和系统日志的区别
4
计算机化系统验证和质量体系、质量风险管理的关联
arithmetic operations, or logic operations(数学运算和逻辑控制), without human intervention(自动，无 人工干预) during a run.
2) A functional programmable(可编程的功能单元) unit that consists of one or more associated processing units and peripheral equipment(处理单元和外部设备), that is controlled by internally stored programs, and that can perform substantial computations, including numerous arithmetic operations, or logic operations, without human intervention(同IEEE).
10
确认与验证的区别
确认和验证在计算机化系统方面的区别
EU Annex 11 Computerized System 2011-06-30 The application should be validated; IT infrastructure should be qualified. 应用需要被验证，基础架构需要被确认 第六条 计算机化系统验证包括应用程序的验证和基础架构的确认，其范围与程度应当基于科学的风险评估。 风险评估应当充分考虑计算机化系统的使用范围和用途。应当在计算机化系统生命周期中保持其验 证状态
14
计算机系统和计算机化系统的区别
计算机系统 Computer System
FDA Glossary of Computer System Software Development Terminology (8/95) (ANSI) A functional unit(功能单元), consisting of one or more computers(一台或多台电脑|服务器) and associated peripheral input and output devices(外部设备), and associated software(软件), that uses common storage(存储空间) for all or part of a program and also for all or part of the data(数据) necessary for the execution of the program(程序); executes user-written or user-designated programs; performs user-designated data manipulation, including arithmetic operations and logic operations(数学计算和逻辑 控制); and that can execute programs that modify themselves during their execution. A computer system may be a stand-alone unit (独立单元)or may consist of several interconnected units(交互单元). See: computer, computerized system. 功能单元 | 一台或多台电脑 | 外部设备 | 软件 | 存储空间 | 数据 | 程序 | 数学计算和逻辑控制 | 独立交互
PIC/S GUIDANCE 2007-09-25
GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED “GXP” ENVIRONMENTS
EU GMP Annex 11 -2011-06-30 A computerised system is a set of software and hardware components which together fulfill certain functionalities.
11
USP 1058中确认与验证区别的描述
12
验证 确认
13
计算机系统和计算机化系统的区别
计算机
• FDA Glossary of Computer System Software Development Terminology (8/95) 1) (IEEE) A functional unit(功能单元) that can perform substantial computations, including numerous
6
确认与验证的区别
MNPA 2010版品生产质量管理规范---定义
确认
证明厂房、设施、设备能正确运行并可达到预期结果的一系列活动。
验证
证明任何操作规程（或方法）、生产工艺或系统能够达到预期结果的一系列活动。
确认和验证的本质区别在于对象不同 验证针对的是流程，确认针对的是单个系统 人员的资质通常用确认（Qualifications） 对象---目标---方法和手段，采用三段论的方法去分析
9
确认与验证的区别PIC/来自系列定义PIC/S Guidance to GMP for Medical Products Annexes 2015-10-01 Concurrent Validation Validation carried out in exceptional circumstances, justified on the basis of significant patient benefit, where the validation protocol is executed concurrently with commercialization of the validation batches. Prospective Validation Validation carried out before routine production of products intended for sale.
确认 厂房确认
公用系统确认 工艺设备确认 分析设备确认
验证 工艺验证
清洁验证 方法验证 计算机化系统验证
7
确认与验证的区别
验证-核实-确认
FDA Guidance for Industry Quality System Approach to Pharmaceutical cGMP Regulations 2006-09 Validation---验证 Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled. Verification---核实 Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.
审计追踪 Audit Trail
MHRA ‘GXP’ Data Integrity Guidance and Definitions 2018-03 The audit trail is a form of metadata containing information associated with actions that relate to the creation, modification or deletion of GXP records. An audit trail provides for secure recording of life-cycle details such as creation, additions, deletions or alterations of information in a record, either paper or electronic, without obscuring or overwriting the original record. An audit trail facilitates the reconstruction of the history of such events relating to the record regardless of its medium, including the “who, what, when and why” of the action. 是一种元数据 | 对GxP记录的活动| 保持原记录可见 | 重现活动
15
计算机系统和计算机化系统的区别
计算机化系统 Computerized System
FDA Glossary of Computer System Software Development Terminology (8/95) Includes hardware, software, peripheral devices, personnel,and documentation; 硬件 | 软件 | 外部设备 | 人员 | 文件
21
审计追踪和系统日志的区别
审计追踪 Audit Trail---WHO的定义
22
审计追踪和系统日志的区别
FDA Glossary
FDA Glossary of Computer System Software Development Terminology (8/95) 1) (ISO) Data in the form of a logical path linking a sequence of events, used to trace the transactions that
确认与验证的区别
PIC/S系列定义
PIC/S Guidance to GMP for Medical Products Annexes 2015-10-01 Process Validation The documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes. Cleaning Validation The gathering of evidence through chemical analysis after each batch/campaign to show that the residues of the previous product or cleaning agents have been reduced below the scientifically set maximum allowable carryover level.
中国 GMP计算机化系统附录-2015-12-01 计算机化系统由一系列硬件和软件组成，以满足特定的功能。
16
计算机系统和计算机化系统的区别
计算机化系统
实验室自动化
工艺自动化
控制仪器 纯信息系统 控制设备 数据汇总
IT基础架构
IT系统 业务流相关
19
计算机系统和计算机化系统的区别
20
审计追踪和系统日志的区别
计算机化系统及CSV,DI培训
1
内容
01/ GMP相关重点概念解析 02/ CSV基础架构确认 03/ GAMP 5基于风险的计算机化系统验证 04/ 系统验证状态保持及运维管理
4
1
5
1 确认与验证的区别
2 计算机系统和计算机化系统的区别
3 审计追踪和系统日志的区别
4
计算机化系统验证和质量体系、质量风险管理的关联
arithmetic operations, or logic operations(数学运算和逻辑控制), without human intervention(自动，无 人工干预) during a run.
2) A functional programmable(可编程的功能单元) unit that consists of one or more associated processing units and peripheral equipment(处理单元和外部设备), that is controlled by internally stored programs, and that can perform substantial computations, including numerous arithmetic operations, or logic operations, without human intervention(同IEEE).
10
确认与验证的区别
确认和验证在计算机化系统方面的区别
EU Annex 11 Computerized System 2011-06-30 The application should be validated; IT infrastructure should be qualified. 应用需要被验证，基础架构需要被确认 第六条 计算机化系统验证包括应用程序的验证和基础架构的确认，其范围与程度应当基于科学的风险评估。 风险评估应当充分考虑计算机化系统的使用范围和用途。应当在计算机化系统生命周期中保持其验 证状态
14
计算机系统和计算机化系统的区别
计算机系统 Computer System
FDA Glossary of Computer System Software Development Terminology (8/95) (ANSI) A functional unit(功能单元), consisting of one or more computers(一台或多台电脑|服务器) and associated peripheral input and output devices(外部设备), and associated software(软件), that uses common storage(存储空间) for all or part of a program and also for all or part of the data(数据) necessary for the execution of the program(程序); executes user-written or user-designated programs; performs user-designated data manipulation, including arithmetic operations and logic operations(数学计算和逻辑 控制); and that can execute programs that modify themselves during their execution. A computer system may be a stand-alone unit (独立单元)or may consist of several interconnected units(交互单元). See: computer, computerized system. 功能单元 | 一台或多台电脑 | 外部设备 | 软件 | 存储空间 | 数据 | 程序 | 数学计算和逻辑控制 | 独立交互
PIC/S GUIDANCE 2007-09-25
GOOD PRACTICES FOR COMPUTERISED SYSTEMS IN REGULATED “GXP” ENVIRONMENTS
EU GMP Annex 11 -2011-06-30 A computerised system is a set of software and hardware components which together fulfill certain functionalities.
11
USP 1058中确认与验证区别的描述
12
验证 确认
13
计算机系统和计算机化系统的区别
计算机
• FDA Glossary of Computer System Software Development Terminology (8/95) 1) (IEEE) A functional unit(功能单元) that can perform substantial computations, including numerous
6
确认与验证的区别
MNPA 2010版品生产质量管理规范---定义
确认
证明厂房、设施、设备能正确运行并可达到预期结果的一系列活动。
验证
证明任何操作规程（或方法）、生产工艺或系统能够达到预期结果的一系列活动。
确认和验证的本质区别在于对象不同 验证针对的是流程，确认针对的是单个系统 人员的资质通常用确认（Qualifications） 对象---目标---方法和手段，采用三段论的方法去分析
9
确认与验证的区别PIC/来自系列定义PIC/S Guidance to GMP for Medical Products Annexes 2015-10-01 Concurrent Validation Validation carried out in exceptional circumstances, justified on the basis of significant patient benefit, where the validation protocol is executed concurrently with commercialization of the validation batches. Prospective Validation Validation carried out before routine production of products intended for sale.
确认 厂房确认
公用系统确认 工艺设备确认 分析设备确认
验证 工艺验证
清洁验证 方法验证 计算机化系统验证
7
确认与验证的区别
验证-核实-确认
FDA Guidance for Industry Quality System Approach to Pharmaceutical cGMP Regulations 2006-09 Validation---验证 Confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled. Verification---核实 Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.
审计追踪 Audit Trail
MHRA ‘GXP’ Data Integrity Guidance and Definitions 2018-03 The audit trail is a form of metadata containing information associated with actions that relate to the creation, modification or deletion of GXP records. An audit trail provides for secure recording of life-cycle details such as creation, additions, deletions or alterations of information in a record, either paper or electronic, without obscuring or overwriting the original record. An audit trail facilitates the reconstruction of the history of such events relating to the record regardless of its medium, including the “who, what, when and why” of the action. 是一种元数据 | 对GxP记录的活动| 保持原记录可见 | 重现活动
15
计算机系统和计算机化系统的区别
计算机化系统 Computerized System
FDA Glossary of Computer System Software Development Terminology (8/95) Includes hardware, software, peripheral devices, personnel,and documentation; 硬件 | 软件 | 外部设备 | 人员 | 文件
21
审计追踪和系统日志的区别
审计追踪 Audit Trail---WHO的定义
22
审计追踪和系统日志的区别
FDA Glossary
FDA Glossary of Computer System Software Development Terminology (8/95) 1) (ISO) Data in the form of a logical path linking a sequence of events, used to trace the transactions that