Electronic Signatures And FDA's 21 CFR Part 11
White Papers The FDA Final Rule provides "criteria for acceptance by FDA .of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper.
[August 14, 2003, 16:19]
Electronic Signatures & FDA: Electronic Signatures And FDA's 21 CFR Part 11
White Papers CIC provides companies with a biometric handwritten electronic signature. Signatures have at least three attributes, form, movement, and variation, and since moving a pen on paper produces the signatures, movement perhaps is the most important part...
[August 2, 2007, 0:22]
Good Electronic Records Management (GERM) Using IBM Rational ClearCase And IBM Rational ClearQuest
White Papers This white paper provides insight into the current capabilities and possible strategies for the operation, use, and extension of the ClearCase and ClearQuest products to address Electronic Signatures, Electronic Records compliance, using 21 CFR...
[December 11, 2003, 2:06]
SAS Drug Development: A Solution For Addressing 21 CFR Part 11 Compliance
White Papers CFR Part 11 requires that the drug sponsor perform validation of systems that support the maintenance and submission of electronic records. The paper also includes a step-by-step explanation of how SAS Drug Development was specifically designed to...
[December 1, 2005, 22:00]
Complying With U.S. FDA Title 21 CFR Part 11 Electronic Records Electronic Signatures Final Rule
White Papers FDA 21 CFR Part 11 Electronic Records Electronic Signatures; Final Rule. This paper provides background information about the regulation, discusses how SAP R/3 complies with this rule, and provides examples of electronic records and signatures...
[December 6, 2004, 2:00]
Healthcare And Pharmaceutical Label Printing
White Papers This white paper introduces some of the FDA regulation 21 CFR (Code of Federal Regulation) Part 11 and discusses how Label Gallery enables you to meet these requirements. In March 1997, the Food & Drug Administration (FDA) issued the final Part 11...
[February 6, 2005, 2:00]
SAS Drug Development - A Solution For Addressing 21 CFR Part 11 Compliance
White Papers The paper also includes a step-by-step explanation of how SAS Drug Development was specifically designed to comply with each subsection of 21 CFR Part 11. This white paper discusses how SAS Drug Development assures the reliability of electronic...
[May 25, 2004, 3:15]
Meeting US FDA 21 CFR Part 11 Requirements
White Papers Food and Drug Administration (FDA) introduced 21 CFR Part 11 (Part 11) regulations to promote wide usage of electronic technology in the life sciences industry in a way that is compatible with FDA's responsibility to protect public health.
[July 13, 2007, 14:11]
Bringing UNIX Networks Into FDA Regulation 21 CFR Part II Compliance With Symark PowerPassword And Symark PowerBroker
White Papers This document demonstrates how Symark PowerPassword and PowerBroker work in tandem to protect the integrity of data across heterogeneous UNIX systems to help bring your system into compliance with FDA Regulation 21 CFR Part II requirements.
[November 30, 2003, 22:47]
DocCompliance And 21 CFR Part 11
White Papers 21 CFR Part 11 governs the management of electronic signatures and electronic records within closed and open systems environments. The ruling placed a burden on pharmaceutical and medical device organizations that use electronic systems for the...
[August 14, 2003, 16:19]
21 CFR Part 11 Requirements For Domino And Notes
White Papers 21 CFR Part 11 is a Food & Drug Administration (FDA) regulation, enacted in 1997, which covers electronic records/electronic signatures when used for FDA regulated activities. The purpose of this paper is to provide technical guidance to users who...
[March 2, 2004, 11:20]
