FDA 21 CFR Part 11 compliant software for TEM based image analysis
Vironova Analyzer Software (VAS) is a tool for computer-assisted analysis of transmission electron microscopy (TEM) images in a GMP compliant environment.
VAS is suitable in regulated environments within the Life science industry where establishment of procedures and controls that ensure integrity, confidentiality, authenticity and reliability in their electronic records according FDA 21 CFR part 11 regulations are required.
VAS helps your organization comply with 21 CFR Part 11
• Access to the system is controlled and different user roles are supported
• Continuously import of acquired images
• Data cannot be changed or deleted
• Audit trail is maintained of all operations carried out by the users
• Electronic signatures can be applied
• Digitally signed analysis reports can be generated
Automation enabled by machine learning
VAS comes with machine learning capabilities making it possible to set up methods to automatically
classify nanoparticles. The machine learning method used is called support vector machines (SVM) and is a supervised learning method. This means that the classifier must be trained on a set of manually classified particles before it can be applied to new, unclassified particles. To do this discrimination it uses a predefined combination of features including shape, size and intensity profile.
Time saved with VAS
Significant time can be saved with VAS. In this example it is shown the time required for the analysis of liposome lamellarity in 20 images of a sample with average quality.
Validated AAV percentage full capsid analysis
Virus particle packaging analysis with cryoTEM in combination with VAS is a patented method and the first validated method in the world for AAV percentage-full-capsid analysis. This method is recommended for batch release testing and QC of AAV-based gene therapy products.