peyt

GMP & 21 CFR part 11-Ready software

Data storage & control across your GMP production pipeline with NucleoCounter® software

0 comments

– 2 minutes

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.

Illustration data management between scientists with different NucleoCounter® NC-202™ instruments and in different locations.

Control software access and user privileges

Table showing the NC-View™ and NucleoView™ software access and user privileges between user groups.

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.

Audit trail

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.

Further resources

  1. Secure Mode User Guide – 21 CFR Part 11 on NucleoCounter® NC-200™ with NucleoView™
  2. Secure Mode User Guide – 21 CFR Part 11 on NucleoCounter® NC-202™ with NC-View™
  3. White Paper – NucleoView™ Software and Code of Federal Regulation 21 Part 11
  4. White Paper – NC-202 – 21 CFR Part11 White Paper

DISCLAIMER

We welcome and encourage blog users to leave comments. ChemoMetec reserves the right to moderate all comments and delete any that could be determined as i) irrelevant; ii) containing spam; iii) containing profanity; iv) deemed offensive or; v) contain questionable content. We reserve the right to withhold any comment from being published. ChemoMetec is not responsible for the content in comments, which represent solely the views of the commenter.

0 Comments

Leave a comment

Your email address will not be published. Required fields are marked *

 *