1. Introduction介绍

2. Scope范围

3. Glossary语

4. Relationship between validation andqualification验证和确认的关系

5. Validation验证

5.1. Approaches to validation验证方法

5.2. Scope of validation验证范围

6. Qualification确认

7. Calibration and verification校正和确认

8. Validation master plan验证主计划

9. Qualification and validationprotocols确认和验证方案

10. Qualification and validation reports确认和验证报告

11. Qualification stages确认阶段

12. Change control变更控制

13. Personnel人员