FDA Compliance Risk Management | Introducing the CRPN Quality Roadmap®

Quantifying FDA Compliance Risk and Remediation Complexity to Structure and Improve Quality Planning and Remediation Outcomes

“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!”                                                                                         – CSL Behring, Marburg Germany

Download our free introductory deck here:
Presentation – Introduction to the CRPN Quality Roadmap®

Also see our case study here:  CRPN Quality Roadmap® Case Study

and a video presentation with Bayer’s VP of Quality, Tina Self here:
Bayer-Compliance Architects® Joint Presentation

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.    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.

What is the CRPN Quality Roadmap®?

CRPN Quality Roadmap PlanningThe 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.

Risk & Planning Use Cases

The CRPN Quality Roadmap® is particularly suited for the following use case scenarios:

  • Quality Improvement Program Development
  • Capital Projects Planning and Portfolio Analysis
  • Audit Response Plan Prioritization
  • Quality Operations Strategic Planning
  • Compliance Risk Reduction Program Planning
  • Quality Activities Portfolio Analysis and Resource Assignments
  • CAPA Risk, Remediation and Resource Planning
  • Complex Enforcement Remediation Planning
  • Executive Stakeholder Financial Planning Alignment Discussions
  • Process Improvement Planning

CRPN Quality RoadmapImproving Executive Stakeholder Alignment

Most significantly, use of the CRPN Quality Roadmap® by Executive Quality Management can create greatly improved executive stakeholder alignment on risk, resource focus, and cost considerations for strategic initiatives and remediation activities.

The CRPN Quality Roadmap® was developed by and is offered exclusively through Compliance Architects®.   For additional information, please contact Jack Garvey at john.garvey@compliancearchitects.com