GxP Consulting

GxP Consulting for industry compliance

idsTrust GxP Consulting

You can expect work automation and productivity improvement through GxP consulting

idsTrust provides consulting on GxP systems required in the fields of pharmaceuticals ·bio·food·cosmetics , including research, clinical trials, licensing, and production.
We benchmark based on the needs of our customers, introduce the most suitable elements and verify their effectiveness.

In addition to the GMP facilities currently in operation, we provide consulting on all IT services required for Digital Healthcare,
such as clinical center project management and development department license management.

Process

We operate a systematic process to implement a successful GxP system

We plan the system implementation to achieve the customer's desired goals.
We provide service to keep the system up to date even after implementation.

  • Planning · Review
    Goal setting and planning
    Establish purpose and action plan
    URS
    Agreed by relevant departments (HO, production, QA, QC)
    Company selection
    Review whether it meets the purpose and strategy
    Training / Implementation readiness
    Adequate training on the system
  • Implementation
    Kick - off
    Milestone review and confirmation (with CSV)Configuration check
    Implementation·Integration
    Preparing system infrastructureSystem linkage (ERP, SSO, MES/POP, QMS)
    Data migration
    Building initial data
    Test / Validation
    DQ, IQ, OQ, PQ response (with CSV)
    Education (encouraging use)
    Training of managers, experts and user groups
    Go-live support
  • Maintenance · Operation
    Go-live stabilization
    Initial issue handlingError/failure patch
    MA
    Defect repair, emergency support
    Upgrade
    Function upgradeSystem interlocking development

Expected effects

Through GxP Consulting, we solve problems in the process and create various expected effects.

Through idsTrust's GxP consulting, each process is automated, and the entire process history management and electronic document management become easy.
Through this, expected effects such as quality management, global competitiveness, productivity improvement, and corporate value increase can be obtained.

기대효과 창출 표