How Hybrid Audits Can Help MDR Compliance in the European Union
The shortage of notified bodies (NB) in the European Union is a key challenge fo [...]
29
11, 2022
15
11, 2022
8 Essential CAPA KPIs to Measure
Corrective and preventive action (CAPA) is a core function in any quality manag [...]
2
11, 2022
Finding the Root Cause: Where Manufacturers Go Wrong
Finding the root cause of a manufacturing quality issue prevents unsafe or poor [...]
12
10, 2022
5 Strategies to Improve Quality Incident Management and Root Cause Analysis
Imagine you’re doing a pre-shipment inspection on multiple pallets containing pr [...]
5
10, 2022
AssurX to Attend ASQ Quality 4.0 Conference and Host CAPA Roundtables
RENO, NEVADA, UNITED STATES, October 4, 2022 -- AssurX, a leader in quality mana [...]
29
09, 2022
5 Building Blocks You Need for a Quality 4.0 Foundation
Market changes and disruptions such as the global pandemic are driving companies [...]
22
09, 2022
Understanding ALCOA+ Principles and Data Integrity for Pharma
Data integrity is a cornerstone of U.S. Food and Drug Administration (FDA) curre [...]
15
09, 2022
Pharmaceutical Warning Letters Reveal CGMP Failures
Current good manufacturing practices (CGMPs) are the cornerstone of drug safety. [...]
1
09, 2022
Why an EQMS is Essential for FDA Remote Regulatory Assessments
The global pandemic brought an unexpected change – FDA remote regulatory assessm [...]
25
08, 2022
EU MDR & IVDR Regulation: Where Does the Guidance Stand?
Companies marketing devices in the European Union are facing a perfect storm of [...]
