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Tapes
Library
21
CFR Part 11: Data Security/Audit Trails in Part-11
Compliant Systems |
|
| Speaker: |
Donald
Palmer, Director, Information Technology, Octagon Research
Solutions |
| Date
of Briefing: |
June
6, 2002 |
| Approximate
length: |
One
hour |
|
Description: |
Participants
will get expert guidance on developing and implementing
sound data security and audit trial procedures for systems
that are subject to 21 CFR Part 11 requirements. |
| Price: |
$195
Tape |
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Tapes
Library
21
CFR Part 11: Beyond Network Validation: Qualifying
adn Network Infrastructures |
|
|
Speaker: |
Thomas
Quinn, CISSP, President and Founder, The Hollis
Group |
|
Date
of Briefing: |
June
4, 2002 |
|
Approximate
length: |
One
hour |
|
Description: |
This
two-part briefing explains why today's IQ/OQ/PQ
comissioning events are inadequate to qualify dynamic,
peer-served computer and network infrastructures.
Then it outlines a methodology, called Concurrent
CNI Configuration Qualification (C3Q), that enables
companies to qualify the CNI as a system and then
include it as a "qualified component"
in a validation process for an application system,
such as a laboratory information management system. |
|
Price: |
$195
Tape |
|
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to the
Order Form |
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October 16, 2006
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