Blog2022-01-15T20:42:38+00:00

AssurX Blog

Straight talk for regulated industries.

2301, 2017

Tougher Quality Management Enforcement By FDA In 2017

January 23rd, 2017|Archives, Medical Device Industry, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

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 [...]

1601, 2017

Risk Management + Quality Metrics Reporting: Revised FDA Guidance

January 16th, 2017|Archives, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management, Risk Management|

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 [...]

901, 2017

CIP Training Management Programs Impacted by NERC Requirements

January 9th, 2017|Archives, Energy & Utilities Industry, NERC Compliance, Regulatory Compliance Management|

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 [...]

1912, 2016

Document Management Problems Threaten Pharmaceutical Manufacturers

December 19th, 2016|Archives, FDA Regulated Industries, Pharmaceutical Industry, Quality Management, Regulatory Compliance Management|

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 [...]

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