Page 15 - Pharmaceutical-Shimadzu Total Solution PICS & FDA Compliance

Shimadzu Electronic Qualification Service

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.

Easy for Customers to Check Qualification in Advance
Example of IQ/OQ Inspection Results Summary Report Output
Example of IQ/OQ Inspection Results Summary Report Output
Example of IQ/OQ Inspection Results Summary Report Output
Example of IQ/OQ Inspection Results Summary Report Output
Shimadzu's electronic qualification documentation service provides an setting values, and control criteria, all of which are presented in a summary
equipment qualification plan (EQP) that allows confirming the overall content of table, making it easy to check the details of items inspected.
Total support as described is available in certain countries. Please contact your local Shimadzu representative for clarification and details.
qualification work before starting each installation, inspection, repair, or other All qualification documents can be saved as PDF files. In addition to manually
qualification process performed by field engineers. This EQP consists of signing printed documents, signatures can be added electronically using Adobe
TM
equipment information that corresponds to the system used to perform the Acrobat functionality.
qualification, including an overview of inspection parameters and procedures,

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