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 

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 

Quality & Compliance Computer-Based Systems

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

Part 11 & Computer Systems Validation

• Part 11 advice / interpretations / compliance implemementations
• 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