The main drivers behind GAMP 5

  1. Scaleable approach to GxP Compliance
  2. Effective Supplier Relationships
  3. Use of Existing Documentation and Knowledge
  4. Configurable Systems and Development Models
  5. Improving GxP Compliance efficiency
  6. Critical Quality Attributes (CQA)
  7. Continuous Improvement within QMS
  8. Quality by Design
  9. Effective Governance to Achieve and Maintain GxP Compliance