GE Healthcare’s IN Cell Analyzer Compliance Manager is designed to aid GxP compliance of the IN Cell Analyzer 2000 system. IN Cell Analyzer 2000 is a high content cellular analysis (HCA) system, a powerful technique for high throughput microscopic analysis of cells which allows deeper insights into cellular behavior whilst improving productivity.
IN Cell Analyzer Compliance Manager is a software module for the IN Cell Analyzer 2000 that brings both operating and analysis software to a 21 CFR Part 11 compliant standard. Developed to facilitate compliance with regulatory expectations worldwide, IN Cell Analyzer Compliance Manager is the first 21 CFR Part 11 compliant software from GE Healthcare for high-content analysis, and delivers required functionality such as:
- Role based user authorization levels to set access rights
- Published procedures for operational control that lock run and evaluation settings together
- Audit trails to record modifications and maintain histories on procedures
- Data integrity and Certificate of Audit
GxP instrument validation services are also available using a risk-based validation approach, to demonstrate compliance and fitness for intended use throughout the equipment’s working life. GxP Validation Services are carried out exclusively by GE Healthcare’s trained service personnel and enable a system to be validated before use and periodically re-evaluated throughout the working life of the instrument.