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.

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Use Cases
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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.


Bayer Pharmaceuticals

California, USA

"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."

CSL Behring

Marburg, Germany

“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

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