液相计算机系统验证报告.docVIP

D-2000 Elite HPLC System Manager Qualification Report Validation NO：QC-VAL-151-01 Suzhou Homesun Wanqing Pharmaceutical Co., Ltd Oct, 2010  Report Confirmation Responsibility Department Name Signature Date Written by QC 李智达 Reviewed by QC 朱旭平 Audited by QC 王瑾 QA 王刚武 Approved by QA 彭志霞 TABLE OF CONTENTS STATEMENT 1 SCOPE 1 REFREENCE DOCUMENTS 1 GLOSSARY 1 RESPONSIBILITIES 2 INSTALLATION QUALIFICATION (IQ) 3 OPERATION QUALIFICATION (OQ) 7 8. PERFORMANCE QUALIFICATION (PQ) 19 9. ATTACHMENT 29 Statement The objective of this protocol is to define the main requirements and