AssurX Blog
Straight talk for regulated industries.
AssurX to Attend ASQ Quality 4.0 Conference and Host CAPA Roundtables
RENO, NEVADA, UNITED STATES, October 4, 2022 -- AssurX, a leader in quality management and regulatory compliance systems, will be attending this year’s ASQ Quality 4.0 Conference being [...]
5 Building Blocks You Need for a Quality 4.0 Foundation
Market changes and disruptions such as the global pandemic are driving companies to adopt Industry 4.0 in their manufacturing operations. Many companies are investing in smart manufact [...]
Understanding ALCOA+ Principles and Data Integrity for Pharma
Data integrity is a cornerstone of U.S. Food and Drug Administration (FDA) current good manufacturing practices (cGMP) regulations. Pharmaceutical manufacturers must ensure data is rel [...]
Pharmaceutical Warning Letters Reveal CGMP Failures
Current good manufacturing practices (CGMPs) are the cornerstone of drug safety. However, it’s an area where many pharma manufacturers still struggle. In fact, 30 percent of FDA pharma [...]
Why an EQMS is Essential for FDA Remote Regulatory Assessments
The global pandemic brought an unexpected change – FDA remote regulatory assessments (RRA). The FDA wants to expand RRA across all product areas to supplement in-person inspections aft [...]
EU MDR & IVDR Regulation: Where Does the Guidance Stand?
Companies marketing devices in the European Union are facing a perfect storm of EU MDR & IVDR regulation challenges. According to a 2022 Medical Device Coordination Group (MDCG) po [...]
