气相再确认方案.doc

PRE-EXECUTION APPROVAL
执行前批准
DEPARTMENT
部门
PRINT NAME/TITLE
姓名/职务
SIGNATURE
签名
DATE
日期
SYSTEM OWNER
系统所属部门
QA
质量保证部
PLETION
OQ完成
This OQ has pleted essfully and is ready for final approval.
本OQ已成功完成,有待批准。
Signature:
签名
Date:
日期
FINAL REVIEW OF DATA AND APPROVAL
数据最终审核及批准
DEPARTMENT
部门
PRINT NAME/TITLE
姓名/职务
SIGNATURE
签名
DATE
日期
SYSTEM OWNER
系统所属部门
QA
质量保证部
APPROVAL DATE:
批准日期
COMMENTS
备注
Purpose: To identify all the individuals who sign or initial any data sheets in this protocol.
目的: 识别所有签字和草签本方案任何数据表的人员。
SIGNATURE/INITIALS LOG
签名/草签确认
PRINT NAME
姓名
PAMY
职务/公司
SIGNATURE
签名
INITIALS
草签
TRAINED ON PROTOCOL (Y/N)
是否接受方案的培训
(是/否)
DATE
日期
GENERAL REQUIREMENTS
要求
1) Execution Rules & Practices 执行原则
Each test will be performed according to the established testing procedure. If any additional information needs to be documented, ments section will be used. The acceptance criteria are considered to be met when the collected data demonstrated that the equipment condition and/or operation are consistent with the requirements and acceptance criteria described in this protocol. The person who executes this protocol will sign their name or initials and date in PLETED BY box. The data obtained will be reviewed by a second person to certify that the test was pletely and this person will sign their name or initials and date in the REVIEWED BY box. Good Documentation Practices (KSP SOP QA-011) will be followed during execution of the protocol.
依照方案中的测试程序执行每一个测试。在备注栏记录附加信息。若所收集的数据证明设备的状态或运行符合方案中规定的要求及验收标准即可判定符合验收标准。方案执行者在填表人一栏中签名及日期。要求第二个人审核数据以确实执行过程及结果,并在审核人一栏中签名及日期。方案执行中需遵照良好的文件记录规范(KSP SOP QA-011)。
2) Exceptional Condition 异常情况
When expected results do not meet acceptance criteria or deviation to an approved protocol, an exceptional condition (EC) is triggered. Any EC will lead to a check mark in “No” box for answering the question of “Acceptance Criteria met?” Record the sequential EC# (01, 02 etc.) on the bottom o