TABLE III

Financial Business Case Considerations

Initial CostCost Comparison: Automated Colony Counter versus Traditional Method
Capital costCapital expenditure
Operational costs· Annual preventive maintenance
· Initial qualification (IQ/OQ/PQ)
· Cost per sample (e.g., costs of consumables)
· Cost of IT support
· Quality & regulatory costs (e.g., as change control or updated documents and filing activities)
  • Abbreviations: IQ, installation qualification; IT, information technology; OQ, operational qualification; PQ, performance qualification.