21 CFR part 11 ready
NucleoView™ Software for NucleoCounter® instruments
In short, the 21 CFR Part 11 defines the FDA acceptance criteria for use of electronic records and electronic signatures as equal to paper records with handwritten signatures.
The NucleoView™ software for NucleoCounter® can be set into a restricted mode, so the user via the software itself cannot violate the 21 CFR Part 11 regulations. This means that on a computer system that is 21 CFR Part 11 compatible, it is possible to keep the compliancy even after installation and use of the NucleoView™.
Data storage and control in the NucleoView™ software
Multiple NucleoCounter® systems can be fully integrated with existing IT networks. Data save locations are configurable and can be saved remotely on networks.
Control over software access and users’ privileges
Use Windows Active Directory defined user groups to control user access and rights within the software. Users can be designated to three different user groups – Admin, Supervisor and User. Admin users have the most rights within the NucleoView™ applications and can switch on or off 21 CFR Part 11 mode in the software. Users belonging to the Supervisor and User groups have restricted rights. When 21 CFR Part 11 mode is activated, data cannot be modified by any user.
All user activity within the NucleoView™ software is recorded in the event log which can only be accessed by users belonging to the Admin group. Event log files are encrypted and protected by a checksum to prevent modification, which the NucleoView™ software authenticates. Exporting event log files can easily be done in PDF or csv formats.