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.
Articles in this issue
Electronic Records Management Practices and Part 11
Applying Part 11 to the Implementation of Quality Management Software
Glossary of terms
The Part 11 Controversy A Root Cause Analysis and Science-Based Solutions Gordon B. Richman
The Part 11 Controversy: A Root Cause Analysis and Science-Based Solutions
Applying Part 11 to the Implementation of Quality Management Software Chet Shemanski and Gregg F. Clyne
Electronic Records Management Practices and Part 11Tamar M. June
21 CFR 11 Overview of the Final Document and its New Scope Ludwig Huber
Ensuring the Integrity of Electronic Laboratory Notebook Records Antony N. Davies and Ann McDonough
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