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