Bio-Rad Bio-Plex Software® Upgrades and Conversions - Manual (Page 138)

Bio-Plex Manager Software 6.1 User Guide | Bio-Plex Manager™ Security Edition
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Background on 21 CFR Part 11
Effective August 20, 1997, the United States Food and Drug Administration
(FDA) released Part 11 “Electronic Records; Electronic Signatures” of Title 21
of CFR. This rule states the conditions under which the FDA considers
electronic signatures and electronic records to be trustworthy, reliable, and
equivalent to traditional handwritten signatures.
Bio-Plex Manager Security Edition is designed to enable organizations and
institutions using the Bio-Plex suspension array system (or Luminex system)
to comply with the rules laid out under 21 CFR Part 11. It enables system
administrators to ensure that Bio-Plex Manager operates in compliance with
21 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).
NOTES:
• The security controls built into Bio-Plex Manager Security Edition
must be properly configured and administered by the system
administrator(s) in your organization. Otherwise, the system will not
be secure and will not be in compliance with 21 CFR Part 11
• Bio-Rad makes no claim that Bio-Plex Manager Security Edition is
CFR-compliant in and of itself, nor does it 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
Standard Mode vs. Secure Mode
Bio-Plex Manager Security Edition can run in Standard Mode, in which all the
security and audit trail features are disabled so that software functions like the
standard version of Bio-Plex Manager, or it can run in Secure Mode, with the
security functions enabled. This chapter assumes you are running the
software in Secure Mode, unless otherwise noted.
When you are in Standard Mode, the status bar displays an “unlocked”
symbol. When you are in Secure Mode, the status bar display a “locked”
symbol.
BioPlex_6.book Page 126 Friday, September 23, 2011 11:55 AM