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.