Services

Engineering

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  • Facilities Design
  • Aseptic Clean Room Design
  • Process Flow Design (Personnel, Equipment, Material, and Waste)
  • Facility Capacity Modeling
  • Lean Six Sigma Manufacturing Process Improvement
  • Micro & Analytical Lab Design

Project Management

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  • Project Feasibility
  • Scope of Work Development
  • Conceptual Development
  • Project Delivery/Planning
  • Project Design
  • Project Implementation
  • Project/Financial Closeout

Validation & Qualification

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  • Validation Master Plan Development
  • Facility Qualification 
  • Equipment Qualification / Validation
  • User Requirements Specification (URS)
  • Factory Acceptance Testing (FAT) Protocol Generation
  • Site Acceptance Testing (SAT) Protocol Generation
  • Initial & Operational Qualification (IQOQ) Protocol Generation
  • Performance Qualification (PQ)Protocol Generation
  • Process Validation
  • Computer Systems Validation (CSV)

Maintenance & Calibration

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  • Development of Computerized Maintenance Management System (CMMS)
  • Development of Preventive Maintenance Program
  • Development of Reliability Centered Maintenance (RCM) Program
  • Development of Total Predictive Maintenance (TPM) Program
  • Development of Calibration Program
  • Development of Computerized Calibration Management System (CCMS)
  • Procedure Development

Regulatory & Compliance

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  • Quality Systems Development & Audits (Documentation Control, Training, Change Control, & Deviation Management)
  • FDA Readiness Audit
  • FDA Pre-Approval Inspection (PAI)
  • Facility Inspections
  • Investigations
    • Corrective Actions
    • Preventive Actions
    • Root Cause Analysis
  • Remediation and Action Plan Development