Attune NxT 21 CFR Part 11 Software | Thermo Fisher Scientific

What is 21 CFR Part 11 Compliance?

The FDA released the Electronic Records and Signatures Rule, known as 21 CFR Part 11 in August 1997.* This rule defines the requirements for use of electronic documents in place of paper documents. The law specifies the system elements, controls, and procedures that are necessary to ensure the reliability of electronically stored records.

This software license for the Attune NxT acoustic focusing cytometer supports compliance with 21 CFR Part 11 FDA guidelines for Security, Auditing, and Electronic Signatures using a SAE console. The Attune 21 CFR software is available for use only on Windows 10 computers. The software features for each part of the 21 CFR guidelines are:

Security

1) Access is restricted to authorized personnel via user ID and password.

21 CFR Part 11 Administration SAE Console to Edit User Account

2a) Passwords and user ID must expire after x days (typically 90 days). 2b) Automatic logout after minutes of inactivity.

21 CFR Part 11 Administration SAE Console where user can set up Name Settings, Password Policy, Account lockout Policy, and Other settings.

3) ID and password must be re-entered to sign or modify record.

21 CFR Part 11 Attune NxT Software provides the ability to sign e-signature reports via the pending signatures dialog where the user enters a specific signature meaning and their user credentials.

4) Must have a method to record and automatically report ‘forgery’ attempts (event notification).

When logging into the 21 CFR Part 11 Administration SAE Console, the user will be notified of specific events as configured in this console such as, enabling/disabling security, user not entering correct password, user session time-out.

5a) Access and manipulation of various software functions are controlled through user role definitions. 5b) Control access to specific areas and options in software.

21 CFR Part 11 Administration SAE Console provides capability to create and modify user roles where permissions can be set for each function within the Attune NxT Software.

* https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application#i (accessed February 27, 2020)

Auditing

Tracks actions performed by users and changes to the SAE module settings. The SAE module automatically audits some actions silently.

You can:

Select to audit specific user actions and specify the audit mode.
Generate reports for audited user actions and SAE module changes.
Generate reports for software or instrument actions and runs.

21 CFR Part 11 Administration SAE Console has a screen where all user actions are logged.

Electronic signature

Determines if users are required to fulfill signature requirements before performing specific functions.

You can:

Configure e-signature so that a user can start a run only if the associated data are signed.
Configure each e-Signature event to require multiple signatures and to require users with specific roles to sign.

21 CFR Part 11 Administration SAE Console has a screen where e-signature settings can be administered to define e-signature meanings and set actions that require signatures.

A record may be signed on demand using the “Sign Record” feature

1) Sign record → pending PDF record preview created.

In the Attune NxT Part 11 application, users can sign experiments by clicking on the sign record button in the SAE ribbon tab which will generate a e-signature report as needed. While generating the report, a progress dialog is displayed.

2) Sign report using appropriate credentials.

When the e-signature report is created, a pdf is generated and is watermarked based on its current status.

3) Experiment signed and user notified modifications will obsolete signature.

When an experiment has a current e-signature status, the experiment workspace will display a message bar indicating that the experiment is currently signed; if modifications are made, it will obsolete the signature.

An end-user may request a signature using the “Request Signatures” feature

1) Request signature → pending PDF record preview created.

Users can request signatures by clicking the request signatures button in the SAE ribbon tab of the Attune NxT 21 CFR Part 11 software; upon requesting signatures the e-signature report is generated and a progress dialog is displayed during report generation.

Upon completion of e-signature report, the report is displayed as a pdf in the request signatures dialog; the user must confirm the SAE request by clicking the request signatures button located on the bottom right of the dialog.

2) Approver notified of e-signature request at login or may view pending signatures.

The e-signatures dialog is displayed when a user logs into the Attune NxT 21 CFR Part 11 Software where the user role is required to fulfill a pending signature request.

3) Approver may sign report and designate reason for signature.

The signed records dialog allows a user to sign an e-signature report for a specific meaning using their credentials to fulfill a pending signature request.

Along with the 21 CFR part 11 software license, our service and support organization offers several services to help you validate you instrument, software, and computer. The following programs are available: IQ/OQ and computer software validation services. Find out more at thermofisher.com/csv