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Qualification Services

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GE Healthcare Life Sciences Qualification Services offers qualification support and documentation.

Compliance Support through Life Cycle Management

Our documentation supports your GE Healthcare Life Sciences equipment throughout its life cycle. We offer: 

  • Significant reduction in time spent for equipment qualification.
  • Consistent verification support throughout product life cycles.
  • Proven history of GxP compliant equipment and satisfied customers, including the world’s leading pharmaceutical and biotech companies.
  • Global network of field support and cGMP trained service staff.
  • Predictable costs and timelines.

Risk-Based Qualification Approach 

The equipment qualification approach is in alignment with GAMP, ISPE and ASTM E2500, whereby qualification support activities and documentation focus on what is critical for end-product quality and are scaled according to customer requirements based on risk and complexity.

Our comprehensive range of documentation and support includes: 

  • Document and Qualification Approach Customizations
  • Installation and Operational Qualification (IQ/OQ)
  • Requalification (RQ)
  • Change Control Protocols (CCP)
  • Continuous Verification

For more information, contact us.