GS-900™ Calibrate Densitometer Regulatory Tools Package (170-7993) by Bio-Rad
Status:
Reviewer
Member since: 2015
Organization: aurobindo pharma
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- Ease of use
- After sales service
- Value for money
Application Area: for vitech 2
"Good for the product and usage of vitech 2 system for new establishment. "
Review date: 11 Feb 2015 | GS-900™ Calibrate Densitometer Regulatory Tools Package (170-7993)
The regulatory tools package combines the GS-900 Installation Qualification/Operations Qualification (IQ/OQ) kit (170-7994) with ImageLab Software, Security Edition 1 license (170-9691).
Use the regulatory tools package to validate the internal calibration for Bio-Rad's GS-900 calibrated densitometry system in cGMP environments. When properly configured and administered, these tools ensure compliance with the rules for secure handling of electronic records as outlined in Title 21, Part 11 of the Code of Federal Regulations (CFR).
Includes one set of protocols for validating the calibration of GS-900 calibrated densitometer (#170-7991), ImageLab™ Security Edition with 21 CFR Part 11 Module.
GS-900™ Calibrate Densitometer Regulatory Tools Package (170-7993) features include:
- Easy-to-follow protocols including instructions for hardware and software installation
- Simple verification of the calibration function
- Access controls and authority checks via user identification codes and passwords
- Electronic record security via protected directories
- Time- and date-stamped audit trails
- Electronic signature of electronic records (user authentication)
