Support for Validation
Support service for configuring a quality assurance system

Summary

The environment surrounding the pharmaceutical industry is changing each day on a global scale. In two areas, namely production processes and information systems, TOYO has experience in the support services for validating and configuring quality assurance systems that always conform to the latest regulations and guidelines.
These services constitute comprehensive support for validation that covers the entire lifecycle of your medical and pharmaceutical facilities and computer systems.

Our Business

TOYO is able to deal with the specialized industries, and offers the comprehensive support services related to validation involved with the entire lifecycle of systems, from product development to system configuration, operation and disposal.

Support service for facility validation

This comprehensive activity starts with facility planning and conceptualization and progresses along with the facility design and construction. TOYO offers a broad range of services for industries required to comply with GMP, such as the manufacturers of pharmaceutical products, quasi-drugs, diagnostic products and medical equipment.

Support service for computer validation

In accordance with the basic concept of computer validation that considers the entire system lifecycle from development to running, operation and disposal, TOYO offers consultation services for a wide range of areas, including production management, production management systems and PLC, facilities, human resources and SOP at worksites.

Support service for GXP

TOYO offers

Consultation services

  • Support for reconfiguration of companywide quality assurance manuals
  • Support for quality assurance system configuration
  • Support for reconfiguration of integrated factory-wide validation system
  • Support for computer validation
  • Audit of suppliers
  • Studies for dealing with electronic records and signatures in other countries

Summary of plans for seminar implementation and quality assurance system configuration

  • Summary of plans for quality assurance system configuration
  • Summary of inspection simulation for GMP
  • Summary of risk assessment
  • Summary of validation master plan
  • Summary of IQ/OQ/PQ implementation plans
  • Summary of supplier audit
  • Summary of computer validation tasks pursuant to GAMP5
  • Summary of validation summary report

Support for facility validation

  • GMP inspection simulation
  • Studies on GMP compatibility
  • Implementation of impact assessment and risk management
  • Preparation of VMP/VSR
  • Support for preparing DQ/IQ/OQ/PQ/PV implementation plans
  • Support for DQ/IQ/OQ/PQ/PV implementation

Support for Computer validation

  • Implementation of impact assessment and risk management
  • Preparation of VMP/VSR
  • Implementation of supplier audit
  • QPP preparation
  • Support for preparing DQ/IQ/OQ/PQ/PV implementation plans
  • Support for implementing DQ/IQ/OQ/PQ/PV
DQDesign QualificationOQOperational Qualification
GAMPGood Automated Manufacturing PracticePQPerformance Qualification
GCPGood Clinical PracticeQPPQuolity Project Plan
GDPGood Distribution PracticeSOPStandard Operation Procedure
GLPGood Laboratory PracticeVMPValidation Master Plan
GMPGood Manufacturing PracticeVSRValidation Summary Report
IQInstallation Qualification  
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