GE Healthcare Life Sciences Validation Services offers IQ/OQ validation support and documentation. To date, we have supplied documentation for over 5000 biopharmaceutical and pharmaceutical projects.
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
For more information, contact us.