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:



Electronic signature

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

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

1) Request signature → pending PDF record preview created.

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