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:
2a) Passwords and user ID must expire after x days (typically 90 days). 2b) Automatic logout after minutes of inactivity.
5a) Access and manipulation of various software functions are controlled through user role definitions. 5b) Control access to specific areas and options in software.
Tracks actions performed by users and changes to the SAE module settings. The SAE module automatically audits some actions silently.
- 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.
Determines if users are required to fulfill signature requirements before performing specific functions.
- 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.
A record may be signed on demand using the “Sign Record” feature
An end-user may request a signature using the “Request Signatures” feature
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
For Research Use Only. Not for use in diagnostic procedures.