液相计算机系统验证方案.doc

D-2000 Elite HPLC System Manager Qualification Protocol Validation No.：QC-VAL-151-01 Suzhou Homesun Wanqing Pharmaceutical Co., Ltd Oct, 2010  Protocol 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) 9 9. ATTACHMENT 11 Statement The objective of this protocol is to define the main requirements and processes for qualification of D-2000 Elite HPLC System Manager used in the laboratory analysis. D-2000 Elite HPLC System Manager is a chromatography data system supported by Hitachi used to control the Techcomp LC2000 HPLC instrument which also supported from Hitachi, the software can execute analyzer’s input automatically including establishing analytical method, executing method program, collecting sample response, acquiring data, reprocessing data and initiating electronic records. Techcomp LC2000 HPLC located in laboratories (including QC laboratory and in-process control laboratory), have been completed IQ, OQ, PQ test and approved for use. In order to prove that D-2000 Elite HPLC System Manager is appropriate for GMP requirements on laboratory computerized system, QC department will execute the qualification. Scope This protocol applies to D-2000 Elite HPLC System Manager used to control Techcomp LC2000 HPLC. This protocol does not apply to LC2000 HPLC Qualification, it only contains applicable software qualification. The instrument qualifications are performed according to QC-VAL-105-01. Chromatography Data System Qualification and HPLC Qualification constitute good operation and maintenance in HPLC application. Reference Documents GAMP Good Practice Guide: Validation of Laboratory Computerized Systems, 2005. PDA technical report 31, ‘Validation and Qualification