Compliance & Quality Assurance

INVIXO Compliance & Quality Assurance 

INVIXO deliver a portfolio of services that are in compliance with regulatory requirements including EU GMP, FDA, EMA, ISO, ICH, GAMP and ISPE within Compliance and Quality Assurance:

Compliance

Quality Assurance

Program & Project Management 

  • End-to-end Compliance Projects 

Process & Equipment Qualification 

  • VMP, PV, PPQ, OQ, DQ, IQ, URS 

Process Training Qualification 

  • Material, Training & Documentation

Computer Systems Validation

  • Machine & IT qualification
  • GAMP 5 & 21 CFR Part 11

Engineering

  • Serialization & Automation
  • Production & Packaging
  • HVAC, Track & Trace 

Performance Development

  • Lean implementation
  • Lean methodology training
  • Organizational Effectiveness

Quality Assurance & Quality Control 

  • SOP writing, Batch documentation 
  • Production support, Non-conformities 
  • In-process/Material Sampling & Analysis

Audit & Inspection

  • QMS subsystem audit/risk mitigation
  • GMP audit execution & reporting 
  • GMP Supplier & Internal audit 

Please contact Kenneth Svindt Rosenhagen at +45 40 20 30 78 if you need counseling, consultancy or a proposition for your project.