ProteOn XPR36, User Manual

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ProteOn XPR36 System
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7
Security Edition
ProteOn Manager™ software, Security Edition is an optional package that
works in conjunction with the built-in security features of the Windows XP
Professional operating system to provide a secure environment for the
maintenance, verification, and tracking of all electronic records generated by
the application. These records include experiments, processed data, analyzed
data, report points, and ProteOn Manager software logs. The tools provided in
the software include:
• Access controls and authority checks through the use of user
identification codes and passwords
• Electronic record security through the use of an experiment
database
• Time- and date-stamped audit trails
• Electronic signature of records (user authentication)
When properly configured and administered, these tools assist with
compliance of Title 21, Part 11 of the FDA Code of Federal Regulations (CFR).
Background on U.S. FDA Part 11
Regulations (21 CFR Part 11)
Effective August 20, 1997, the U.S. FDA released Part 11 “Electronic Records;
Electronic Signatures” of Title 21 of CFR. This rule states that the conditions
under which the FDA considers electronic signatures and electronic records to
be trustworthy, reliable, and equivalent to traditional handwritten signatures.
ProteOn Manager software, Security Edition is designed to enable
organizations and institutions using the ProteOn™ XPR36 system to comply
with the rules laid out under 21 CFR Part 11. It enables system administrators
to ensure that ProteOn Manager software 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)).
The security controls built into ProteOn Manager software, Security Edition
must be properly configured and administered by the system administrator(s)
in your organization. See Appendix F for instructions. Otherwise, the system
will not be secure and will not be in compliance with 21 CFR Part 11.
Note: Bio-Rad makes no claim that ProteOn Manager software,
Security Edition is CFR-compliant in and of itself, nor does it
guarantee compliance for the user. Your organization must