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Articles (32)

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1-10 of 32 results for 21 CFR

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Select article: 21 CFR Part 11: The Role of Predicate Regulations and Associated Internal Policies

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First published 2003-4

21 CFR Part 11: The Role of Predicate Regulations and Associated Internal Policies

Tammala D. Woodrum

Therapeutic Innovation & Regulatory Science

Select article: Society of Toxicologic Pathology Position on Histopathology Data Collection and Audit Trail: Compliance with 21 CFR Parts 58 and 11

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First published 2004-01

Society of Toxicologic Pathology Position on Histopathology Data Collection and Audit Trail: Compliance with 21 CFR Parts 58 and 11

Darrell Tuomari, Glenn Elliott, Barbara Kulwich [...]

Toxicologic Pathology

Select article: 21 CFR Part 11: How Does it Affect Laboratory Automation Software Developers?

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First published 2002-6

21 CFR Part 11: How Does it Affect Laboratory Automation Software Developers?

Robert M. Brown

Journal of Laboratory Automation

Select article: Society of Toxicologic Pathology Position Paper on Pathology Image Data: Compliance with 21 CFR Parts 58 and 11

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Research article

First published 2007-4

Society of Toxicologic Pathology Position Paper on Pathology Image Data: Compliance with 21 CFR Parts 58 and 11

Darrell L. Tuomari, Ramon K. Kemp, Rani Sellers [...]

Toxicologic Pathology

Select article: Image Compression in Morphometry Studies Requiring 21 CFR Part 11 Compliance: Procedure Is Key with TIFFs and Various JPEG Compression Strengths

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Research article

First published 2004-2

Image Compression in Morphometry Studies Requiring 21 CFR Part 11 Compliance: Procedure Is Key with TIFFs and Various JPEG Compression Strengths

Mark W. Tengowski

Toxicologic Pathology

Select article: Electronic Record Challenges for Clinical Systems

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First published 2001-7

Electronic Record Challenges for Clinical Systems

Lisa Olson

Therapeutic Innovation & Regulatory Science

Select article: Overview and Architecture of the Java Integration Framework,Hybrid Scheduler,and Web-Enabled LIMS

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First published 2004-12

Overview and Architecture of the Java Integration Framework,Hybrid Scheduler,and Web-Enabled LIMS

Paul Rodziewicz, Blane Bell

Journal of Laboratory Automation

Select article: Migrating,Archiving,and Reconstructing Electronic Records in a Regulatory Environment

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First published 2001-1

Migrating,Archiving,and Reconstructing Electronic Records in a Regulatory Environment

Tammala D. Woodrum

Therapeutic Innovation & Regulatory Science

Select article: Good Laboratory Practice (GLP) Regulations: Interpretation Techniques and Review of Selected Compliance Issues

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First published 2006-1

Good Laboratory Practice (GLP) Regulations: Interpretation Techniques and Review of Selected Compliance Issues

Christine S. Lee, John Y. Lee

Therapeutic Innovation & Regulatory Science

Select article: Interim Analysis: What Regulatory Affairs Professionals Need to Know

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First published 2010-11

Interim Analysis: What Regulatory Affairs Professionals Need to Know

David Coutant

Therapeutic Innovation & Regulatory Science

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