Quality Assurance and Engineering

“Our budgets have been cut and we can’t seem to get our CAPAs closed.”

“All of our investigations say Operator Error — somethings wrong with that.”

“Our processes have way too much scrap and failure — we need to be much more efficient and reduce our fixed costs!”

Compliance Architects® provides the following expert advisory and consulting services:

CRPN Quality Roadmap®

The CRPN Quality Roadmap® is a consulting service offering comprised of a defined, structured 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.

 

Product Quality Consulting

  • Quality by Design (QbD) systems & approaches
  • HACCP Quality Plans
  • Operational Excellence
  • Process Criticality Analysis
  • FMEAs, CAPA Investigations, Investigation Training

Quality Culture Assessment

Compliance Architects® provides industry’s first formal, scientific assessment methodology that assesses an organization’s quality and compliance training, awareness, knowledge, intent, culture, and capability.

Operational Efficiency / Compliance Effectiveness

  • Operational Excellence programs
  • “Compliance Aware” Process Excellence
  • “Lean Compliance”
  • Business process modeling & re-engineering
  • Risk management plans
  • Metrics and Governance Systems Development

Project / Program Management

  • Compliance remediation project management
  • Operational improvement projects
  • Investigations project management
  • Commercialization & regulatory submissions