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2. PURPOSE 目的
1.2. The purpose of this procedure is to harmonise the structure and
principles of computer systems validation within Actavis.
此程序目的是规范阿特维斯的计算机系统验证
3. SCOPE 范围
1.3. This procedure pertains to all computer systems which are
considered to be GXP critical and for which validation has been deemed
necessary.
此程序适用于所有涉及 GXP 要求的确定需要验证的计算机系统
4. RESPONSIBILITY 职责
1.4. It is the responsibility of the relevant department manager to
ensure that GXP critical computer systems are validated.
各相关部门经理负责确保涉及 GXP 要求的计算机系统经过验证。
1.5. It is the responsibility of the Quality Affairs manager, in cooperation
with relevant department managers of each site to delegate responsibility for
computer systems validation and to ensure that adequate resources are
available to perform the necessary validations.
质量事务经理负责协调各区域的相关部门经理分配计算机系统验证职责,以确保适当的资
源实施必要的验证。
1.6. The individuals in charge of computer systems validation at each
site are responsible for the relevant Validation Project Plan(s) and the overall
progress of validation activities.
各区域负责计算机系统验证的个人负责相关的验证项目计划及整个验证过程。
5. DEFINITIONS 定义
1.7. Computer System: A system of one or more computers and
associated software.
计算机系统:由一个或多个计算机及关联软件组成的系统。
1.8. Computer System Validation: Documented evidence that a
computer system conforms consistently to user requirements and is under
control and qualified for its intended use. The completed validation
deliverables with references to or including the applicable supporting
documents constitute the validation package.
计算机系统验证:证明一个计算机系统符合设计要求、受控并且始终如一地满足用户需求
的形成文件的行为。
6. PROCEDURES 规程
General 概要
1.14. Each site shall have an inventory list over computer systems in use,
with their GAMP (Good Automated Manufacturing Practice) classification, GXP
criticality, the extent of validation required and the validation status.
每一个场所均应有在用计算机系统的详细清单及其 GAMP(良好自动制造行为规范)分类,
GXP 风险程度,需要验证的程度及验证情况。
1.15. Actavis shall review and approve validation protocols that are
purchased from a vendor, prior to the validation.
在验证前,阿待维斯应复核及批准从供应商购买的验证草案。
1.16. When validation activities are conducted by a vendor, the validation
work shall be witnessed by Actavis personnel. When the validation is completed
the validation report shall be approved by Actavis.
当验证活动由供应商管理时,验证工作应由阿待维斯人员证明。当验证结束时,验证报告
应由阿待维斯批准。
to public health and safety, risk to the business, expected lifetime and history
of use. The validation work is the same as listed above but the extent of the
effort is based on the evaluation.
由于使用的风险将会用于评估遗留系统的验证使用。必须评估的主要因素有:公众健康安
全的风险、商业风险、预期寿命、使用历史。验证工作与上述一样,但进行的程度是基于
评估。
Retirement 退役
1.33. Retirement of validated computer systems shall be documented. A
backup of the system software and a copy of system documentation shall be
retained and stored with the Retirement Protocol for a defined period of time.
已验证的计算机系统的退役需要有文件归档。系统软件的备份和系统文件副本应与退役方
案一起保存至确定的时间。
1.34. If the system data is not transferred onto a new computer system, it
shall be backed up and retained for minimum of 11 years (any data which
product registration is based on may need to be kept for a longer period of
time). If the system hardware is specially designed for the system it shall be
retained with the data.
如果系统数据没有转移到新的计算机系统,应有备份并保存至少 11 年(产品注册的基础
数据需要保存更长时间)。如果系统硬件是为系统特别设计的,它应与数据一起保存。