Shimadzu Total Solution for PIC/S and FDA Compliance

Network System to Regulatory Compliance

Provide Required Documents

  • Shimadzu can provide documents for validation plans, required specifications, functional specifications, supplier check list, etc. for regulatory compliance.
  • Shimadzu helps customers effectively create required documents.


Installation and IQOQ Inspection
  • IQOQ is performed by field engineers certified by Shimadzu Corporation to ensure secure inspection.
  • A standardized inspection protocol allows engineers to effectively perform an IQOQ in a short time.
  • This service reduces space for storage of documents and improves visibility of inspection results.
  • Currently this service supports HPLC, UV and TOC. Other instruments will be supported sequentially.

 

Provides Summary Report of IQ/OQ Inspection Results
Customers are provided with a summary report of installation information recorded for IQ, such as the serial and model numbers of instruments included in the IQ process, as well as setting values, control criteria, and pass/fail results for each OQ inspection parameter. This summary report helps ensure that customers can confirm inspection results and the regulatory authority can audit efficiently.

Example of IQ/OQ Inspection Results
Summary Report Output

Total support as described is available in certain countries. Please contact your local Shimadzu representative for clarification and details.

Support for Document Creation

To ensure regulatory compliance, system and operational management procedures must be documented, and the equipment must be operated in accordance with these procedures, necessitating operational conditions besides the functions that the equipment being used possesses. In addition to the many procedures generally administered by the equipment manufacturer, Shimadzu also provides services to support the creation of documents for regulatory compliance. We provide detailed, total support across the entire system lifecycle, from discussions prior to system introduction to periodic inspections after introduction, and even system replacement. In addition, we respond promptly to trends across the globe, such as new requirements from regulatory agencies, thereby maintaining a flawless support organization always capable of responding to customer requirements.
 

This is an optional service. Total support as described is only available in certain countries.
Please contact your local Shimadzu representative for clarification and details.

For Research Use Only. Not for use in diagnostic procedures.

This page may contain references to products that are not available in your country. Please contact us to check the availability of these products in your country.

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