Bio-Rad Image Lab™ Software - Manual (Page 179)

User Guide | 179
13 Using the Security Edition
21 CFR Part 11
Image Lab™ Security Edition is a module within the Bio-Rad Image Lab software
that assists users in meeting the Food and Drug Administration’s regulations on
good lab practices in the pharmaceutical and biotechnology industries. The Security
Edition enables system administrators to ensure that Image Lab operates in
compliance with Title 21 of the Code of Federal Regulations (CFR) Part 11 within a
closed system. A closed system is defined as “an environment in which system
access is controlled by the persons who are responsible for the content of electronic
records that are on the system” (Section 11.3 (b) (4).
Note:
 Image Lab Security Edition is not supported by the Mac.
 The security controls built into Image Lab Security Edition must be properly
configured and administered by the system administrator(s) in your
organization in order to be secure and in compliance with 21 CFR Part 11.
 Bio-Rad makes no claim that Image Lab Security Edition software is
CFR-compliant in and of itself, nor does the company guarantee
compliance for the user. Your organization must establish policies and
standard operating procedures that work in conjunction with the tools
provided by Bio-Rad to ensure compliance with 21 CFR Part 11.