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 validation support throughout product life cycles
• Global network of field support
• Predictable costs and timelines

Risk-Based Qualification Approach 

The equipment qualification approach is in alignment with GAMP, ISPE and ASTM E2500, whereby validation 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)
• Change Control Protocols (CCP)
• Continuous Verification
• Decommissioning

For more information, contact us.