CSV Computerized System Validation
Release time:
2024-10-25
1. Computer system verification (CSV verification) is an important part of quality assurance in the pharmaceutical and related industries, and it is the part that must be verified in the 2010 GMP appendix. Durst's validation team has a deep background in the pharmaceutical industry, validation consulting, and a deep understanding of domestic and international GMP regulations and rich practical experience. Can provide you with computer verification services for compliance with GMP requirements such as FDA, EU, TGA, NMPA, etc.
1. Computer system verification (CSV verification)It is an important part of quality assurance in the pharmaceutical and related industries, and it is the part that must be verified in the 2010 GMP appendix. Durst's validation team has a deep background in the pharmaceutical industry, validation consulting, and a deep understanding of domestic and international GMP regulations and rich practical experience. Can provide you with computer verification services for compliance with GMP requirements such as FDA, EU, TGA, NMPA, etc.
2. Verification scope:
Durst Computer Systems Verification TeamHe has provided verification services for many foreign-funded, state-owned enterprises and other pharmaceutical companies and software developers in China. He is very familiar with computer system verification and has GAMP 5 verification capability. The verification scope includes but is not limited:
(1) System software:
ERP enterprise management system, WMS warehouse management system, WCS warehouse control system (Lizhu Group, Shenzhen Zhonghe Hedway, Shanxi Zhendong Pharmaceutical, Shanghai Danrui Pharmaceutical, Shenzhen Jiuxin Pharmaceutical, Zhuhai Fitelan, etc.)
QMS Quality Management System (Trackwise \Shanghai Hongyi)
LIMS Laboratory Management System (Oz Pharmaceutical Project)
DMS File Management System (Shanghai Hongyi)
(2) Production equipment and public system
BMS, EMS system (Respril Project, Centone Pharmaceuticals, Rizumab, etc.)
PMS environmental monitoring system (Xiantong Pharmaceutical, Lizuzumab, etc.)
HMI/PLC man-machine operation interface/programmable logic controller (stock solution equipment, purification equipment, preparation equipment, such as bottle washing machine, tunnel oven, filling machine, tablet press, coating machine, etc.) (Shengnuo Biology, Xiantong Pharmaceutical, Lizuzumab, etc.)
PCS production control system (Shengnuo Bio, Xiantong Pharmaceutical, Lizuzumab, etc.)
DCS distributed control system (Shengnuo Bio, Xiantong Pharmaceutical, Lizuzumab, etc.)
SCADA DCS, etc. (Shengnuo Bio, Xiantong Pharmaceutical, Lizuzumab, etc.)
(3)QC instruments and equipment:
ELN CDS (Shimadzu/Agilent/Waters Online Edition Software), stand-alone instruments (UV, IR, PCR instruments, fluorescence instruments, cell counters, etc.) (North China Pharmaceutical, Shanxi Nuocheng Pharmaceutical, North Hunan Wellman, Shenzhen Zhonghe Haide Wei, Guangdong and Macao Pharmaceutical, Jiangsu Keben Pharmaceutical, Guangdong Xinghao Pharmaceutical, etc.)
3. Verification process:
3.1V Validation Model
3.2 Validation Control Point
4. Validation process and delivery
5 Specific cases
ERP-WMS System Verification
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Durst advantage: DurstHave a professional team according to the function and actual use of the customer's computerized system, make a list of computerized systems, and classify them, carry out verification services according to the current standards, and help the customer's project meet the FDA/EMA/PICS/WHO verification requirements. |
Durst Success Story (partial):
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North China Pharmaceutical: CSV verification of laboratory instruments and equipment, involving data integrity and computerized system verification training. |
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Zhejiang Jingwei Pharmaceutical Co., Ltd. (FDA cGMP project): Laboratory data integrity and CSV training and on-site guidance to help companies successfully pass FDA cGMP certification inspections. |
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Xiangbei Wellman Pharmaceutical Co., Ltd. (NMPA and European and American GMP standards): Validation of the laboratory online version of the chromatographic system and the stand-alone version of the instrument. |
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Shenzhen CNNC Hyde Bio (EU and PIC/S standards): 1. Overall solution of laboratory data backup and verification service; 2. Computerized system verification of laboratory instruments and equipment. |
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Shanxi Nuocheng Pharmaceutical Co., Ltd. (PIC/S standard): Overall PIC/S project, CSV project involving key production equipment; and CSV project for laboratory instruments; Data Integrity Guidance. |
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Anshi Pharmaceutical (Zhongshan) Co., Ltd. (FDA cGMP and PIC/S project) Data integrity guidance and production data integrity training, CSV system construction, personnel training, etc. |
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Jiangsu KeBen Pharmaceutical Co., Ltd. Computerized System Verification Project (CSV) Involving QC laboratory HPLC, GC, LC, FTIR, UV, etc. Production System Validation |
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Zhuhai Lizhu Group (FDA cGMP and NMPA): involving Lizhu microspheres, Lizhu monoclonal antibody and Lizhu pharmaceutical factory. 1. Lenovo cloud CSV project, laboratory CSV training, data integrity guidance review, CSV system construction, etc. 2. WMS System Verification Project |
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Beijing Lianxin Pharmaceutical (NMPA Standard) Drug Traceability System Verification Project, GAMP Category 5 Customized Software Test software code, verify code report analysis, and verify overall execution. |
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Shanghai Dan Rui Biomedical Technology (NMPA and FDA cGMP) Infor ERP & production control system, involving the design review of the system, the overall verification of the system on-line, PQ verification after delivery, etc. |
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Kangfang Biomedical Co., Ltd. (FDA cGMP and NMPA) CSV items of production equipment |
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Zhangjiagang Huanyu Pharmaceutical Equipment Co., Ltd. (FDA cGMP and NMPA) Overall validation guidance for key production equipment and CSV validation overall project services. |
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Guangdong Xinghao Pharmaceutical (FDA cGMP) CSV verification of key equipment and instruments involved in the laboratory, CSV verification training, etc., and zero defect inspection in CSV. |
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Shanghai Hongyi Software Technology Co., Ltd. (DMS Project) Software development guidance and software CSV verification guidance. |
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Guangzhou Zhuoge Information Technology Co., Ltd. (software development) ...... |
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Contact Information
Durst (Shenzhen) Consulting Service Co., Ltd.
Contact Phone:86-18826007039
E-mail:consulting@delsalt.com
Address: C19, Building 1, Yongheyuan, Zhuangbian Community, xixiang street, Bao 'an District, Shenzhen City, Guangdong Province
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