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Cryovial System - Coggle Diagram
Cryovial System
5 Compliance Transition Activities
System Validation
Regulatory Approval
Submit necessary documentation to relevant organizations (ie. FDA)
Exhibit GMP compliance
Training
New procedures - ie. automation alternative
SOP update
Modifications to Setup
Installation of new equipment - go through necessary qualification process
Storage modifications
Testing
Compatibility with existing procedures and workflows
Alternative: Pre-Filled & Pre-Sealed Single-Use Tube System
Integrated Barcoding
Bolsters tracking and inspection procedures
Automated
Pre-filled and pre-sealed to reduce reliance on open manipulation and error-prone pipetting
Torque-Controlled Sealing
Pre-sealed factory tubes are uniform