What Are the Risks of Using AI in Regulated Quality Systems?
Artificial intelligence is rapidly entering quality and regulatory functions across the life sciences industry. From document analysis and gap assessments to trend detection and compliance monitoring, AI offers meaningful efficiency gains. However, in regulated...
How Does AI Change the Role of QA and RA Professionals?
The short answer: AI does not replace QA or RA expertise. It reshapes it. When implemented correctly, AI reduces administrative burden, increases visibility, and elevates QA and RA professionals into more strategic, decision driven roles. The Traditional QA and RA...
Navigating the 2026 QMSR: What Medical Device Manufacturers Must Do Before February 2, 2026
The U.S. Food and Drug Administration (FDA) is implementing one of the most consequential quality system changes for medical device manufacturers in decades. Effective February 2, 2026, the FDA’s new Quality Management System Regulation (QMSR) replaces the long...
How Does AI Integrate With Existing QMS or eQMS Platforms?
As life science organizations face increasing regulatory complexity, many are turning to artificial intelligence to strengthen quality and regulatory compliance. Yet one question consistently rises to the top: How does AI integrate with existing QMS or eQMS platforms...
How to Integrate AI Into Quality and Regulatory Compliance
Artificial intelligence is reshaping nearly every function in life sciences — from drug discovery to manufacturing optimization. Yet one of the most impactful, and often overlooked, applications of AI is in quality and regulatory compliance. For MedTech and life...
How do you prepare for an unannounced audit from a Notified Body or the FDA?
Few phrases make quality teams more anxious than “unannounced audit.” Whether it’s a Notified Body conducting a surprise visit under the EU MDR/IVDR or an FDA investigator arriving unannounced for an inspection, these audits test your organization’s true level of...