AssurX Blog
Straight talk for regulated industries.
Tougher Quality Management Enforcement By FDA In 2017
Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape. Quality Management Efforts Will Be Impacted In 2017 I [...]
Quality and Compliance Management System Provider AssurX Promotes John Kielty to Vice President of Sales
MORGAN HILL, CA (January 17, 2017) – AssurX, Inc., a leading enterprise quality management and regulatory compliance platform provider, announced the promotion of John Kielty to Vice P [...]
Risk Management + Quality Metrics Reporting: Revised FDA Guidance
Risk management remains a strong focus of the FDA. A revised FDA guidance offers new details and hones the scope previewing the agency's pilot test of a risk-based system to track phar [...]
CIP Training Management Programs Impacted by NERC Requirements
Conducting a cybersecurity training management program gap analysis is critical for regulated utilities to ensure NERC compliance in 2017 and beyond. Cyber Security Qualifications Bols [...]
Part I: Enterprise Quality Management System Selection Best Practices
Editor's Note: In this two-part series, you'll learn common pitfalls to avoid and the most effective ways to select an Enterprise Quality Management system. Selecting an enterprise qua [...]
Document Management Problems Threaten Pharmaceutical Manufacturers
Document management problems could soon impact the momentum in the number and speed of drug approvals for the pharmaceutical industry. FDA’s Office of Generic Drugs (OGD) record Fiscal [...]