Medical software NanoBrook 21CFR Part 11

measurementimportWindows

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 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.