Vironova Analyzer Software (VAS)

FDA 21 CFR Part 11 compliant software for TEM based image analysis

From image to proof with the benefit and ability to extract information from images, remove subjectivity, provide accuracy and traceability.

Automation enabled by machine learning

The only GMP compatible TEM analysis software helping your organization to be FDA 21 CFR Part 11 compliant

Saves significant time while reducing human error

Automation enabled by machine learning

Helps your organization 21 comply with CFR Part 11

VAS explained

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.

Complying 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

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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.

The trained classifier is proven for the ability to discriminate between filled and empty particles. To do this discrimination it uses a predefined combination of features including shape, size and intensity profile. 

The classifier can be applied to all particles in an mage or to individual particles separatel in a similar way as the manual classification tool.

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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. Using VAS instead of doing the imaging, detection, classification and reporting manually can save your organization 12 hours per sampled analyzed. 

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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.

An image caputured with Vironova Analyzer Software - one can also see that pattern is identified
A cryoEM graph

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