The MuScan software has been designed to fully meet CFR compliancy. The software is completely digital, meaning no paper-based documentation is required. Dependent on customer demands, it allows a cyclic or linear double eye data confirmation approach. All data can be stored on the customers' server or the MuScan PC. Full password management and complete logging of all actions is included. The CFR21 part 11 compliant MuScan software relies on image analysis of the scans obtained from the MuScan device. Diagnostic algorithms incorporated in the MuScan software ensure accurate detection and quantification of the organisms of interest.
Audit trails and training
The MuScan CFR software provides tools for audit trails and searches within logged data. All data needs to be assessed by at least two individuals. Each modification made to the data is logged, avoiding errors in interpretation of the data. The software meets all CFR requirements and upon request IQ/OQ documentation can be purchased for rapid installation and operational testing of the MuScan device including the software. To allow an easy start, a dedicated training for use of the CFR software provides all features of the software when used as operator, Reviewer and Administrator. Please contact us for more information.
Besides CFR compliancy, the MuScan software can also be installed as so-called R&D package. This allows users in a research and development environment to use all advantages of the MuScan software, without the need for CFR-required limitations like double eye data confirmation. Testing and modifying image analysis protocols is allowed using the R&D MuScan software, providing custom protocol development for detection of your targets of interest.