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last updated:Aug 07, 2023

エヌケイエス 本社
エヌケイエス 本社
  • Official site

Solve everyone's daily validation concerns online!

We hold "online consultation sessions" to propose solutions from the perspective of those responsible for practical work in the field. Our company has responded to customer needs in various manufacturing sites for pharmaceuticals, medical devices, and regenerative medicine. From the standpoint of those engaged in practical work in the field, we will explore solutions tailored to your situation regarding the challenges of validation (qualification and calibration) required for manufacturing equipment and more. 【Some inquiries from customers】 ■ I have questions about the content of the NKS Webinar lectures. ■ I would like to know more about our validation process. ■ What should I be careful about when calibrating equipment during validation? ■ I would like to consult about the documentation for the IOQ of manufacturing equipment (in accordance with ICH Q7). *For more details, please refer to the PDF materials or feel free to contact us.

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オンライン相談会.PNG

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オンライン相談会.PNG
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  • Related Link - https://www.nks-wa-hakaru.jp/

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【Inquiries from Other Customers (Excerpt)】 ■ I attended the NKS Webinar and realized the importance of validation/calibration; I would like to consult for more detailed and specific information. ■ I would like to discuss how to proceed with the CSV (Computerized System Validation) for disinfection equipment. ■ Are there any standards for identifying residues in cleaning validation? ■ I am considering the IOQ for used equipment, but there are no documents such as manuals or functional specifications, so I would like to consult about this. ■ I would like to discuss the transportation validation of biopharmaceutical active ingredients. *For more details, please refer to the PDF document or feel free to contact us.

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【Concerns (Excerpt)】 ■ I don't know what to implement for the validation required by the standards. ■ I want to know what to include in the validation plan for qualification evaluation and calibration. ■ I don't understand how to perform validation. *For more details, please refer to the PDF document or feel free to contact us.

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エヌケイエス

エヌケイエス 本社

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We provide calibration services for measuring instruments and measuring devices. We also offer validation services for equipment and testing devices aimed at the pharmaceutical and food industries. Over the past 25 years of operation, we have built a solid track record. Number of customers served: over 8,000 facilities. Types of calibratable measuring instruments and measuring devices: over 700 types, equipment and testing devices: over 30 types. Our validation services are provided as a one-stop service, from the preparation of the validation plan to completion.

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