FDA Quality Consulting – Systems and Training

FDA Quality Consulting – Systems and Training

“We’re just not where we should be with our systems, or our product & process knowledge to ensure product quality for the future.”

“We have reorganized and acquired companies without updating our systems — and now no one is sure what system to follow.”

“Our external suppliers are making changes without telling us.”

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

Quality System & Compliance Turnarounds / Restructuring

  • Quality System Redevelopment
  • Review / rewrite Quality Manual
  • Review / rewrite Policies & SOPs
  • Review / rewrite batch records, DMRs, etc.
  • Review / redevelop CAPA, Training, Change Control, Validation, Management Review, etc. systems
  • Metrics Development
  • Governance Models
  • Executive Issue Tracking & Accountability

Training / Coaching

  • Custom GxP Training Programs
  • Compliance Coaching
  • Inspection Preparation Training
  • Supplier Management Training
  • Quality Staff Assessment / Development Programs

Quality & Compliance Computer-Based Systems

  • Document management
  • Knowledge management
  • ERP Integration / Planning
  • IT/IS Strategic Plans
  • Regulatory submissions / SPL / XML

External Supply Chain Compliance

  • Vendor selection criteria development & vendor qualification
  • Quality agreement development
  • Supplier management training
  • Third party product / service monitoring / auditing
  • Assessment metrics
  • IS / IT solutions for supplier monitoring

Part 11 & Computer Systems Validation

  • Part 11 advice / interpretations / compliance implementations
  • Part 11 IS Quality Systems
  • CSV Program Structure

Turnkey Quality Systems

  • Quality systems development
  • Develop & implement Quality Manual
  • Develop & implement Policies & SOPs
  • Develop & implement batch records, DMRs, etc.
  • Develop & implement CAPA, Training, Change Control, Validation, Management Review, etc. systems
  • Develop & implement governance programs, metrics, etc.
  • Computer systems assessment / recommendations
  • Quality “Software as a Service”
  • Outsourced compliance staff