Quantifying FDA Compliance Risk and Remediation Complexity to Structure and Improve Quality Planning and Remediation Outcomes
In another breakthrough innovation, Compliance Architects® has developed the first off-the-shelf, highly-structured methodology and corresponding web-based application to help regulated life-science companies assess risk and develop corresponding strategic and tactical remediation plans in a pragmatic, resource-considered approach.
What is the CRPN Quality Roadmap®?
The CRPN Quality Roadmap® is a highly-structured service offering comprised of a defined methodology, proprietary risk and complexity algorithms, and cloud-based software tool that together facilitates intelligent, semi-quantitative, risk-based planning for regulated, life-science manufacturers.
The capability of the CRPN Quality Roadmap® enables companies to rapidly assess, aggregate and formally prioritize their portfolio of risks, issues, objectives, etc. for both risk and complexity considerations. Using this approach, and with a comprehensive understanding of relative risk rankings, companies can consider and determine most appropriate resource utilizations, given risk rankings and the complexity of remediation activities.
TRUSTED BY THE WORLD'S BEST COMPANIES
"When I joined Bayer…. we were working on all these things and making progress, but we weren’t really fixing anything immediately. And it’s because I might be working on five things, I’m not focusing on that one which I might be able to get completed earlier which is actually a higher priority."
“Compliance Architects helped us to prioritize our quality and compliance initiatives in a risk based manner, which enabled us to focus on what matters most. Many thanks to Jack, Colleen and Ken for their dedication and great work!”
Quantifying FDA Compliance Risk
and Remediation Complexity
The CRPN Quality Roadmap® service offering has been embraced and utilized by some of the world’s most respected companies, helping to drive effective quality planning activities, and facilitating both strategic planning and tactical remediation efforts.
Quality Improvement Program Development
Capital Projects Planning and Portfolio Analysis
Audit Response Plan Prioritization
Quality Operations Strategic Planning
Compliance Risk Reduction Program Planning
Process Improvement Planning
Executive Stakeholder Financial Planning Alignment Discussions
CAPA Risk, Remediation and Resource Planning
Complex Enforcement Remediation Planning
Quality Activities Portfolio Analysis and Resource Assignments
Timeframe: Two to Six Months
Overview of Methodology / Approach
CRPN Quality Roadmap® Benefits
• Alignment of stakeholders on risk considerations, using a formal,structured methodology for quantifying FDA compliance enforcement risk
• Algorithms transform qualitative risk information and assumptions into quantitative data for compliance risk reporting and comparability purposes
• The method and tool introduces a novel complexity factor into planning to facilitate resource considerations and organizational capability
• The easy-to-use software tool that allows regulated life-science manufacturers to develop data-driven quality and remediation plan documents for capital and expense budgeting and project resource prioritization planning
Speak with the FDA Risk Management Experts
Give us a call - 888.734.9778
Get started TODAY on your risk management transformation journey! We'll send you a comprehensive powerpoint deck that'll help you to understand, with much more granularity, how everything works.