GMP and 21 CFR Part 11-Ready Software
Data Storage and Control Across Your GMP Production Pipeline with NucleoCounter® Software
21 CFR Part 11 defines the US Food and Drug Administration’s (FDA) acceptance criteria for use of electronic records and electronic signatures as equal to paper records with handwritten signatures. Our NucleoCounter® instruments are 21 CFR Part 11-ready; in other words, you can fully integrate single or multiple instruments into your existing IT networks. You can also configure the locations where data is saved and save it remotely.
You can operate the NC-View™ and NucleoView™ software (for the NucleoCounter® NC-202™ and NC-3000™ respectively), in restricted mode to ensure you remain compliant with 21 CFR Part 11 regulations. This means that on a computer system that is 21 CFR Part 11 compatible, it is possible to maintain the level of compliance during use.
Control Software Access and User Privileges
Use Windows Active Directory-defined user groups to control users’ access and rights within the NC-View™ and NucleoView™ software. There are three user groups: Admin, Supervisor, and User. Admins have the highest level of privileges and can switch on or off the 21 CFR Part 11-mode in the software. In comparison, Supervisors and Users have more restricted privileges. When 21 CFR Part 11-mode is activated, all users are unable to modify data during acquisition and also after the data is stored.
All user activity within the NC-View™ and NucleoView™ software programs is recorded in the event log, which can only be accessed by users in the Admin group. Event log files are encrypted and protected to prevent modification, which the software authenticates.
Results are saved in encrypted data files and can quickly and easily be exported from the software in PDF or CSV formats. You can customize where you choose to save your data and results.
- Secure Mode User Guide – 21 CFR Part 11 on NucleoCounter® NC-200™ with NucleoView™
- Secure Mode User Guide – 21 CFR Part 11 on NucleoCounter® NC-202™ with NC-View™
- White Paper – NucleoView™ Software and Code of Federal Regulation 21 Part 11