GE Healthcare has introduced the IN Cell Analyzer Compliance Manager, which 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 that allows deeper insights into cellular behavior, while 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.
It provides required functionality such as: role-based user authorisation levels to set access rights; published procedures for operational control, which lock run and evaluation settings together; and 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.
