Invitrogen
™
iBright
™
SAE Software
Solution for 21 CFR Part 11
Support
Security Audit e-Signature (SAE) for the iBright
™
Imager
IMPORTANT!
21 CFR part 11 is a regulation that describes the criteria for
acceptance by the U.S. Food and Drug Administration (FDA) for electronic records
and electronic signatures. Part 11 is composed of procedural and technical
requirements. Procedural requirements are the standard operating procedures
instituted by the end user, and technical requirements are the functional
characteristics of the compliance management software used.
This section is intended to provide instructions for using Security, Audit, and E-
Signature (SAE) on board iBright
™
Imaging Systems. Security, Audit, e-Signature
(SAE) software provides the tools necessary for supporting 21 CFR Part 11 technical
compliance including:
• Creating and maintaining user accounts
• Managing and enforcing password policies of all accounts
• Assigning, managing and enforcing access rights to all accounts
• Documenting and maintaining audit and e-Signature histories
• Permitting e-Signature approval for data verification
To implement the iBright
™
SAE Software Solution for 21 CFR Part 11 support on
iBright
™
Imaging Systems, you need the following components installed, activated,
and communicating:
•
SAE Administrator Console
— With the iBright
™
Imager Analysis Application
Profile, used to configure the SAE settings for iBright
™
Imaging Systems
•
iBright
™
SAE License
— Used to activate the SAE settings for the iBright
™
instrument and desktop analysis software
•
iBright
™
Instrument – SAE Mode
— Firmware connected with the SAE
Administrator Console
•
iBright
™
Analysis Software – Secure
— Desktop analysis software connected
with the SAE Administrator Console
Note:
For details on accessing iBright
™
SAE Software Solution downloads and
resources, see the "Related documentation and references" section.
34
iBright
™
CL750 Imaging System User Guide
