Amersham™ ImageQuant™ 800 GxP
Designed for 21 CFR Part 11 compliance
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Key benefits of ImageQuant™ 800 GxP
- Log on to the imager with Windows® authentication to ensure a single continuous period of access that is secure and controlled.
- Assign users to user groups for controlled system access.
- Electronic records and event logs: Retrieve time-stamped audit trails and image files with relevant capture information that is embedded and protected.
- Check image authenticity automatically with ImageQuant™ TL (IQTL) GxP analysis software before analysis.
- Data traceability: Enter your electronic lab notebook reference number to ensure electronic data traceability back to experimental steps before imaging.
- Full documentation and validation support: Sign up for Cytiva’s regulatory support to access full development documentation, change control notifications, and external assessment reports.
GxP offering for regulated environments
ImageQuant™ 800 GxP is specifically designed to meet the requirements of regulated lab environments like FDA 21 CFR part 11 and EU GMP Annex 11 - where data traceability, accountability, and integrity are critical.
The ImageQuant™ 800 GxP offering includes a suite of regulatory support documentation including a third party 21 CFR part 11 certification and services that enable you to meet industry requirements with confidence.
Traceability in Western blot imaging: Considerations for GxP
Traceability, accountability, and data integrity are fundamental to regulated (GxP) environments, helping ensure safe, high-quality products. In gel and blot imaging, compliance goes beyond image capture it requires traceability across the entire electrophoresis workflow, from sample handling to final data management.
Additional resources
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Discover ImageQuant™ 800 GxP
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Discover ImageQuant™ TL software
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Discover ImageQuant™ 800 systems
