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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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Go to the Order Form

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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