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Total Support for Regulatory Compliance

Support for Document Creation D B C S

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

Introduction System System Operational Retirement
Plans Introduction Management

Validation plans Validation reports Periodic inspections Renewal plans

Sample Architectural
Documentation
Definition of Performance
user requests Qualification (PQ)
[System Developmental Documents]
Validation Plans
Supplier evaluations Definition of User Requests
Supplier Assessment Plans and Reports
Functional Specifications
Configuration Establishment Specifications
DQ Plans and Reports
Functional Operational IQ/OQ/PQ Plans and Reports
specifications Qualification (OQ)
Validation Reports, etc.

[System Operational Management
Configuration Installation
establishment Qualification (IQ) Documents]
specifications Operational Management Standards
Documentation Management Procedures
Configuration Management and
Change Management Procedures
System Management Procedures
Configuration establishment Security Management Procedures
Backup and Recovery Procedures
Archiving Procedures
Troubleshooting Procedures
Design Education and Training Implementation
Qualification (DQ) Procedures, etc.

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