The NanoBrook 21CFR Part-11 Compliance Software

The NanoBrook 21CFR Part-11 Compliance Software allows authorized and trained users to make light scattering measurements (DLS, ELS, PALS) using a Brookhaven NanoBrook system.

NanoBrook 21CFR Part 11 Compliance Software

The NanoBrook 21CFR Part 11 Compliance software is for use with the family of NanoBrook light scattering instrumentation.  This software has the ability to assign users with specific roles that are password protected to ensure that the measurements performed are tracked to a specific user. Other requirements to be compliant to 21CFR Part 11 include the ability to log activities by user and maintain the integrity of data by preventing any manipulation of it.

 

 

Features at a glance

  • User Specific, Password Protected, Roles
  • Activity Log by User and Time Period
  • Remote Database Access
  • Ability to Import Data from Existing NanoBrook Software

Overview

In 1997 the Food and Drug Administration (FDA) issued the final part 11 regulations as part of Title 21 for Food and Drugs in the Code of Federal Regulations.  21CFR Part 11 or sometimes-called 21CFR11 documents the requirements for the handling of electronic records and signatures that are to be maintained or submit information to the FDA.

Some of the key features to be compliant with 21CFR Part 11 include the ability to create specific users with unique passwords, the ability to have an audit trail for any activities that are performed, and the prevention of any changes to measurement data.  The NanoBrook 21CFR Part 11 Compliance Software satisfies the requirements outlined by the FDA.

Addition features include the ability to assign Operator and Supervisor roles based on permissions for creating and/or modifying Standard Operating Procedures (SOPs).  Any changes to a SOP can be tracked in the activity log.

Current customers of Brookhaven with NanoBrook instrumentation or those that have data from a previous generation of DLS/PALS software have the ability to import their data.

 

Password Protected Log In

An important part for 21CFR Part 11 compliance is the ability to track measurement data to a specific user. To satisfy this requirement the user account is password protected requiring alphanumeric and special characters.

 

 

 

 

 

 

User Account Profiles

Account profiles are created based on the role of the user. Privileges vary by profile and options include Administrator, Supervisor, and Operator roles. The user account is password protected using standard alphanumeric with special character requirement. The password can be set to expire at any date in the future or disables. A period of time of user inactivity can be set to automatically log the user out to prevent the accidental measurements by a different user.

 

 

 

 

 

Activity Log Review by User

The activity log allows for the tracking of activities of all users. Activities include when a user logs-in, types of measurements performed, and when SOP’s are created or modified. The time period to review is selectable along with the option to review a single user or all users.

 

 

 

 

 

 

Remote Database Connection

The software application allows for the ability of a user to access the database from a remote workstation within the organization by entering in the network path and credentials to the server with the database files. The ability to test the connection allows for a quick diagnostics.

 

Specifications

Supported Instruments:

  • NanoBrook Omni
  • NanoBrook 173Plus
  • NanoBrook 173
  • NanoBrook 90Plus PALS
  • NanoBrook 90Plus Zeta
  • NanoBrook 90Plus
  • NanoBrook ZetaPALS
  • NanoBrook ZetaPlus
  • Dynamic Light Scattering (DLS) for Particle Size Determination
  • Electrophoretic Light Scattering (ELS) for Zeta Potential
  • Phase Analysis Light Scattering (PALS) for High Sensitivity Mobility Measurements

 

Recommended Requirements:

Windows 10 Pro, Windows 11 Pro, and Windows 10 Enterprise.*

*May require additional setup/configuration.

 

A policy of continual improvement may lead to specification changes.

Applications

The 21CFR-11 NanoBrook Instrument Control Software software allows authorized and trained users to make light scattering measurements (DLS, ELS, PALS) using a Brookhaven NanoBrook system, an instrument platform with a variety of supported hardware configurations, in a way that is compliant with the restrictions set forth by 21CFR Part 11.

Contact Us

To request more information or to purchase the NanoBrook 21CFR Part 11 Compliance Software, please fill out the form below. A sales engineer will contact you with more information.

Not sure where to start?

Our dedicated team of experts is standing by to help you find the right instruments for your testing needs.

Contact us today to see how we can help.