Dot Compliance

JANUARY 7, 2025

Electronic Quality Management Systems (eQMS) help meet these demands by streamlining processes, helping to meet compliance, and supporting continuous improvement across the enterprise. Training Management Training plan creation: Develop and manage training plans that align with organizational needs and regulatory requirements.

Medical Device Industry 59

Medical Device Industry Regulatory Compliance Compliance FDA 59

Dot Compliance

MARCH 17, 2022

All while keeping in mind that compliance to regulations and global standards are non-negotiable, especially in the highly regulated life science and biotech industries. Here are key points to consider when selecting a QMS solution to support your company’s compliance and growth.

Regulatory Compliance 52

Regulatory Compliance Compliance Records Management FDA 52

Dot Compliance

DECEMBER 7, 2022

What is Quality Management System (QMS)? How Do Quality Management Systems Help Businesses Increase Profitability? Quality Management System Examples 4. Dot Compliance eQMS Essential Elements 5. Ensuring Compliance with ISO 9001, EU MDR, FDA & More 6. Quality Management System Development 7.

FDA 52

FDA Compliance Records Management 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

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 40

FDA Compliance Public Health Governance 40

SQA

JUNE 3, 2024

Additional findings included concerns with respect to document control, records management, and lack of compliance with Standard Operating Procedures (SOPs). FDA has prepared a draft document entitled Food and Drug Administrations Draft Report and Plan on Best Practices for Guidance. PDA Technical Report No.

FDA 40

FDA COVID-19 Licensing Nurses 40