What is a Quality Management Review and Why Do You Need Them?
This is the first installment of a two-part series focusing on the importance of [...]
28
04, 2022
20
04, 2022
Understanding FDA Alignment of ISO 13485 with Quality System Regulation
The FDA’s official proposal to align its Quality System Regulation (QSR) with IS [...]
7
04, 2022
FDA Warning Letters Highlight Food Safety Compliance Issues
The U.S. Food and Drug Administration (FDA) has issued dozens of warning letters [...]
31
03, 2022
miraDry Implements AssurX Quality Management and Regulatory Compliance Software
MORGAN HILL, CA, UNITED STATES, March 31, 2022 – AssurX, Inc. (AssurX), a leader [...]
31
03, 2022
How an EQMS can Reduce CAPA and Complaint Observation Trends
As we move through 2022, we look forward to new opportunities, new challenges, a [...]
24
03, 2022
5 Tips for Turning GMP Audits from an Adversarial to a Cooperative Process
This article is part two of a two-part series focused on GMP quality audit manag [...]
17
03, 2022
Remote Quality Audits for Regulated Companies Come of Age
This article is part one of a two-part series focused on GMP quality audit mana [...]
3
03, 2022
How to Conduct Remote Supplier Quality Audits in a QMS
Since the Covid pandemic, regulators and notified bodies have been doing more re [...]
24
02, 2022
Trend Watch: 2022 and Beyond Will see Maturation of Internal Control Programs
Technology, Politics, Climate, and the Coronavirus will Drive Maturation of Int [...]
9
02, 2022
7 Benefits of Quality Risk Management in the EQMS
Regulators and standards organizations are increasingly requiring manufacturers [...]
