How to manage DHF
DHF Principles In this article, I would like to explain how to manage DHF. This is because most medical device […]
Why do human errors occur?
Why do human errors occur? Human error always occurs with a certain probability. Then, why do human errors occur? The
From “Validation” to “Verification
From “Validation” to “Verification”: The Evolution of Computer System Assurance in Pharmaceutical Manufacturing Historical Context: GAMP 4 and the Compliance
What is GxP data?
What is GxP data? The term GxP may be unfamiliar to some readers.GAMP 5, published in 2008, is titled “A
Which Companies Are Subject to FDA Inspections: Understanding the Risk-Based Site Selection Model
Introduction One of the questions frequently posed to regulatory affairs professionals is: “What types of companies are subject to routine
Understanding “User” in Computer System Validation: Regulatory Perspectives and Modern Approaches
Introduction: The Ambiguity of “User” in CSV Context In the implementation of Computer System Validation (CSV), the term “user” appears
Are You Confusing Part 11 with Data Integrity? Understanding the Critical Distinction
Introduction: A Persistent Industry Misconception In recent years, pharmaceutical companies have invested substantial resources in data integrity compliance initiatives. However,
Competence Table and Training Needs: A Comprehensive Guide to Personnel Management in Regulated Industries
Introduction Competence management represents a critical foundation of quality management systems in regulated industries, particularly in pharmaceutical and medical device
What is Maintaining Validation Status?
Understanding Validation in Computerized Systems In computerized system validation (CSV) and the modern Computer Software Assurance (CSA) approach, the most
Understanding Risk in Quality Management: A Conceptual Framework for Pharmaceutical and Medical Device Industries
Introduction: The Evolution of Risk Definition in Quality Standards The concept of risk has undergone significant evolution in quality management
