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 reliable and accura [...]
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 after it has proven [...]
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) position paper, mo [...]
FDA Expands Medical Device Cybersecurity Draft Guidance to Stress Importance of Quality System
As innovation in medical technology increases, potential cybersecurity threats also grow. The U.S. Food and Drug Administration (FDA) expects medical device manufacturers to fully incorporate cybersec [...]
EUDAMED Update: What You Need to Know Now
The European Union (EU) Medical Device Regulation (MDR) officially went into effect in May 2021, while the In-Vitro Device Regulation (IVDR) took effect in May 2022. The new legislation established th [...]
EU Medical Device Regulation Still Presents Challenges and Opportunities
EU Medical Device Regulation (MDR) has been in effect for almost a year. As anticipated, the regulation has proven to be as challenging as the industry expected it would be. Now, companies also have t [...]
Understanding FDA Alignment of ISO 13485 with Quality System Regulation
The FDA’s official proposal to align its Quality System Regulation (QSR) with ISO 13485:2016 was long in coming, but worth the wait. Regulatory authorities consider it necessary to improve medical dev [...]
Trend Watch: 2022 and Beyond Will see Maturation of Internal Control Programs
Technology, Politics, Climate, and the Coronavirus will Drive Maturation of Internal Control Programs Technology, politics, climate, and the Coronavirus pandemic are four conditions that will influenc [...]
Energy & Utilities Resources
Resources ENERGY & UTILITIES AssurX Resource Center for Energy & Utilities We’ve assembled Energy and Utilities resources including brochures, data sheets, guides, videos, testimon [...]
Energy & Utilities
NERC Compliance Software ASSURX ECOS ENABLES NERC COMPLIANCE, IDENTIFIES RISK, AND TRACKS ACTIVITIES ACROSS YOUR ORGANIZATION AssurX Delivers Compliance Solutions for Constantly Changing [...]
