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|Articles|June 1, 2005

Pharmaceutical Technology

  • Pharmaceutical Technology-06-01-2005
  • Volume 205 Supplement
  • Issue 3

The Part 11 Controversy: A Root Cause Analysis and Science-Based Solutions

The confusion surrounding the application of 21 CFR Part 11 can be solved by focusing on the common rationale that both protects the public health and drives the fundamental basis of the industry's business: good science.
External Link - article-167194.pdf

Articles in this issue

over 21 years ago

Electronic Records Management Practices and Part 11

over 21 years ago

Applying Part 11 to the Implementation of Quality Management Software

over 21 years ago

Glossary of terms

over 21 years ago

The Part 11 Controversy A Root Cause Analysis and Science-Based Solutions Gordon B. Richman

over 21 years ago

Applying Part 11 to the Implementation of Quality Management Software Chet Shemanski and Gregg F. Clyne

over 21 years ago

Electronic Records Management Practices and Part 11Tamar M. June

over 21 years ago

21 CFR 11 Overview of the Final Document and its New Scope Ludwig Huber

over 21 years ago

Ensuring the Integrity of Electronic Laboratory Notebook Records Antony N. Davies and Ann McDonough

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