HIPAA Journal

NOVEMBER 4, 2022

The white paper suggests several areas where policies could be changed to improve cybersecurity in the healthcare industry. Cybersecurity can no longer be viewed as a secondary concern; it must become incorporated into every organization’s – from equipment manufacturers to health care providers – core business models.”.

HIPAA 126

HIPAA Governance FDA Medicaid 126

Dot Compliance

OCTOBER 11, 2024

It helps ensure product quality, patient safety, regulatory compliance and more. Regulatory Compliance Adherence to regulatory requirements, such as those outlined by the FDA’s 21 CFR Part 820, is mandatory for pharmaceutical manufacturers. CAPA as a Strategic Tool A good CAPA system is not just a “nice-to-have.”

Pharmaceutical Industry 52

Pharmaceutical Industry Regulatory Compliance Compliance FDA 52

Dot Compliance

OCTOBER 11, 2024

It helps ensure product quality, patient safety, regulatory compliance and more. Regulatory Compliance Adherence to regulatory requirements, such as those outlined by the FDA’s 21 CFR Part 820, is mandatory for pharmaceutical manufacturers. CAPA as a Strategic Tool A good CAPA system is not just a “nice-to-have.”

Pharmaceutical Industry 52

Pharmaceutical Industry Regulatory Compliance Compliance FDA 52

Dot Compliance

FEBRUARY 23, 2024

The Evolution of Quality Processes Years ago, quality management professionals relied on using manual, paper-based systems for managing their quality processes. Their tasks included documenting quality processes, obtaining signatures from authorized individuals, and storing documents for regulatory compliance.

FDA 52

FDA Regulatory Compliance Compliance 52

SQA

OCTOBER 18, 2024

Level 2: When a simplified analysis of the EFRA inspection report is performed to evaluate compliance with the GMP requirements and may be adopted unilaterally by ANVISA. The classification criteria include: Serious deficiencies: Typically linked to non-compliance with critical items. Major deficiencies: Associated with major items.

FDA 52

FDA Compliance Public Health World Health 52

Dot Compliance

MARCH 7, 2023

Such a tool can help you achieve compliance, improve quality and avoid risk. FDA 21 CFR part 11 requires a manufacturer to perform “Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.”

Compliance 40

Compliance FDA 40