Services

Industry validated best practices for GxP systems

Quarterly compliance trending reports, active links to regulations & warning letters for rolling 24 month report period.

FDA Compliance Activity Data Monitoring and Reporting (483Pulse)

Baseline Assessment

GxP Systems Assessments Using a Formal Methodology And Best Practices To Identify Areas Of Strengths And Opportunities. Assessments are conducted using data from cross functional partners of the Quality Organization obtained during focused meetings and shared with a small management (core) team for collaboration and objective scoring of best practice criteria.

Intelligence Reports for Pharmaceuticals, Medical Device, Biologics and Dietary Supplements. Each report contains current FDA regulator activity data as noted in FDA Form 483 observations. The data is presented in visualizations providing an easy-to-understand format communicating critical trends. Active links to all warning letters as well as links to all relevant regulations dramatically reduces time needed to search FDA sites.

Report narration of the written report greatly enhances the user experience.

Standard and custom dashboard visualizations for pharmaceutical, medical device, biologics and dietary supplement citation level detail. All visualizations use ComplyFDA’s proprietary database of all regulatory activity. Custom visualizations may be created upon request for in depth analysis of governing regulation subparts and constituent regulations.
This is a focused assessment of the quality management system for life sciences organizations. Baseline assessments are designed to provide an efficient and objective view of quality system risks to determine strategies for improving FDA and ISO investigation outcomes. Baseline assessments incorporate best practices and provide both an objective score as well as actionable improvement recommendations.

Industry validated best practices for GxP systems

GxP Systems Assessments Using a Formal Methodology And Best Practices To Identify Areas Of Strengths And Opportunities. Assessments are conducted using data from cross functional partners of the Quality Organization obtained during focused meetings and shared with a small management (core) team for collaboration and objective scoring of best practice criteria.

GxP systems assessments using DMAIC (six sigma) and best practices to identify areas of strengths and opportunities.

GxP Assessments

Quarterly compliance trending reports, active links to regulations & warning letters for rolling 24 month report period.

Intelligence Reports for Pharmaceuticals, Medical Device, Biologics and Dietary Supplements. Each report contains current FDA regulator activity data as noted in FDA Form 483 observations. The data is presented in visualizations providing an easy-to-understand format communicating critical trends. Active links to all warning letters as well as links to all relevant regulations dramatically reduces time needed to search FDA sites.

Report narration of the written report greatly enhances the user experience.

Intelligence Reports for Pharmaceuticals, Medical Device, Biologics, Dietary Supplements

Regulatory Activity Data Monitoring and Reporting

Standard and custom dashboard visualizations for pharmaceutical, medical device, biologics and dietary supplement citation level detail. All visualizations use ComplyFDA’s proprietary database of all regulatory activity. Custom visualizations may be created upon request for in depth analysis of governing regulation subparts and constituent regulations.

Standard and custom dashboard visualizations for pharmaceutical, medical device, biologics and dietary supplement citation level detail

Baseline Assessment

This is a focused assessment of the quality management system for life sciences organizations. Baseline assessments are designed to provide an efficient and objective view of quality system risks to determine strategies for improving FDA and ISO investigation outcomes. Baseline assessments incorporate best practices and provide both an objective score as well as actionable improvement recommendations.