We will assist you with CSV compatibility while keeping the guidelines of each sector in mind.
At Pharma Planning Co., Ltd., we provide support for CSV compliance based on GAMP5, taking into account various guidelines. We also assist with CSV compliance for systems that our customers are implementing. Additionally, we offer CSV compliance support for suppliers entering the GxP industry, so please feel free to inquire. 【Features】 ■ Support for CSV compliance considering various guidelines ■ CSV compliance support for suppliers entering the GxP industry *For more details, please refer to our catalog or feel free to contact us.
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【Our Proposed Solutions】 ■ We will assist you in complying with CSV based on GAMP5, considering global guidelines such as the Ministry of Health, Labour and Welfare's guidelines for the proper management of computerized systems, FDA Part 11, and PIC/S guidelines. ■ We will support the establishment of a CSV compliance framework not only for the target system but also for your quality management system. ■ We will propose practical CSV solutions that can be realistically built and operated, ranging from spreadsheets to DCS. *For more details, please refer to our catalog or feel free to contact us.
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【Purpose】 ■ When it is necessary to comply with the Ministry of Health, Labour and Welfare guidelines, as well as global CSV requirements. ■ When introducing new technologies from new suppliers, and CSV compliance is needed. ■ When unsure about what to do with a spreadsheet's CSV, etc. *For more details, please refer to the catalog or feel free to contact us.
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Pharma Planning Co., Ltd. is a comprehensive production-type company that responds to customer needs through GMP-compliant consulting, including CSV, as well as the planning, development, and clinical trials (GCP) of generic pharmaceuticals utilizing a global network, and the sale of raw materials. We also provide optimal solutions for customers considering entering the pharmaceutical and medical device markets. Furthermore, leveraging our network with pharmaceutical companies overseas, including in the United States, China, Taiwan, and Vietnam, we can offer global support in pharmaceutical-related businesses, so please feel free to consult with us.
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