Risk-Based Computer System Validation
  • Utilizing the FDA guidelines for risk-based validation, the HighPoint team delivers all validation documents and perform all validation activities required, speeding the time to system deployment when compared with traditional validation approaches.
  • For those clients looking to incorporate the risk-based validation approach into their current methodology, the HighPoint team can quickly assess the current methodology, determine changes, and deploy the new methodology including necessary training.
  • Technology and business process knowledge of projects germane to all phases of the drug/device lifecycle from development to commercialization.