FSMA Finalizes Animal Food Guidance on Hazard Analysis and Preventive Controls
Alignment with the Food Safety Modernization Act (FSMA) is necessary for manufac [...]
15
12, 2022
9
02, 2022
7 Benefits of Quality Risk Management in the EQMS
Regulators and standards organizations are increasingly requiring manufacturers [...]
20
01, 2022
Making the Business Case for an Electronic Quality Management System
Part 2 of a three-part EQMS blog series If you’re responsible for establishing o [...]
4
01, 2022
Quality Risk Management: A Proven 4-Step Process
There’s no question that quality risk management is becoming an indispensable to [...]
1
06, 2020
How Risk-Based Testing is Revolutionizing Computer System Validation
We live in a world where speed is vital to success. Patients and consumers expe [...]
21
02, 2020
Human Error is a Precipitator for Root Cause Analysis, Not Blame
Have you ever been part of a process that had a failure or two? Perhaps you’ve b [...]
3
10, 2017
Take Action for ISO 13485:2016 Certification Preparedness
ISO 13485 has undergone its first major overhaul of manufacturing system require [...]
30
01, 2017
Risk Management Best Practices for Cybersecurity Compliance
A new FDA guidance concerning risk management helps medical device manufacturers [...]
16
01, 2017
Risk Management + Quality Metrics Reporting: Revised FDA Guidance
Risk management remains a strong focus of the FDA. A revised FDA guidance offers [...]
31
12, 2016
Part I: Enterprise Quality Management System Selection Best Practices
Editor's Note: In this two-part series, you'll learn common pitfalls to avoid an [...]
