Page 21 - Shimadzu’s Solutions for Impurities Analysis

Support from Shimadzu

Validation Support

˙ Validation Support from Shimadzu for Analytical
Instrumentation

In response to validation for analytical instrumentation and computerized systems required by GxPs, Shimadzu organizes
documentation, such as IQ/OQs, certificates of verification and inspection reports, based on ISO9001 verification.
Furthermore, our qualified service engineers support customers' validation requirements. Genotoxic Impurities FDA Regulations on

Design Qualification (DQ) Support Total Support with Consultation and
Maintenance Contract
AIQ requires design qualification (DQ) in the selection process
of analytical instruments. As factors of the DQ, Make this a By making the best use of our comprehensive expertise in
lower case qualification of suppliers and conformity of the a variety of analytical instruments, Shimadzu provides
instrument’s specifications to the user’s requirements are of total support for total validation management by
necessity. Close collaboration between the user and supplier is offering consultation and maintenance contracts.
important for smooth DQ. Shimadzu's comprehensive support will help to improve
Shimadzu intensively supports customer’s DQ for supplier laboratory’s environment and data reliability.
evaluation and actively engages with the customer to ensure
the instrument's specifications meet the user's requirements. Residual Solvents FDA Regulations on

Installation Qualification (IQ) Support
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Installation qualification (IQ) requires the analytical
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recorded documents but also IQ work by our trained and
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maintenance (PM) and preventive validation are also
available. IQ documents Support from Shimadzu
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