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

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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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Drug Solutions Podcast: Growth and Advancements in Fill/Finish

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In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

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Cynthia A. Challener

Artificial intelligence and machine learning can help identify complex patterns.

May 28th 2024

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

July 21st 2025

FDA Appoints New CDER Director, George Tidmarsh

Susan Haigney

George Francis Tidmarsh, MD, PhD, founding co-director of Stanford’s Master of Translational Research and Applied Medicine program, has been appointed as the new director of the Center for Drug Evaluation and Research.

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EMA Moves to Secure Supply of Critical Drugs Used During Pregnancy

Susan Haigney

The agency’s Executive Steering Group on Shortages and Safety of Medicinal Products has issued recommendations to address vulnerabilities in the supply chain of anti-D immunoglobulins.