The regulatory tools package combines the GS-900 Installation Qualification/Operations Qualification (IQ/OQ) kit (170-7994) with Image Lab 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).
- Easy-to-follow protocols including instructions for hardware and software installation
- Simple verification of the calibration functions
- 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)
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