GOALS

FDAAWARE platform benefits cover a wide range of compliance and operation areas to meet various goals and needs.

  • PROVIDES “REAL” TIME ACCESS TO COMPANY-SPECIFIC COMPLIANCE RISK INFORMATION
    • provides customers with instant view of their specific compliance risks based on their profile and current exposure.
  • EMPOWERS COMPANY BY PROVIDING INSIGHT INTO POTENTIAL FDA INSPECTION AGENDA
    • provides customers with potential FDA inspection details by pairing historical FDA inspection data with company-specific risk areas, while fully integrated with 21 CFR document.
  • ENABLES EFFECTIVE RESOURCE ALLOCATION
    • enables customers to invest resource time to address compliance deficiencies as opposed to searching for them.
  • SUPPORTS MANAGEMENT DECISION MAKING PROCESS
    • provides information, which enables Management to make the right decisions at the right time regarding quality improvements.
  • IMPROVES COMPANY'S FDA INSPECTION READINESS AND HARMONIZATION
    • improves customer's ability to successfully pass FDA inspections by steering company's preparation efforts to key focus areas.
  • REDUCES RISK EXPOSURE
    • reduces monetary and operations impact on the business resulting from quality issues.
  • FACILITATES EFFECTIVE PROJECT IDENTIFICATION AND PRIORITIZATION
    • enables customers to efficiently prioritize and manage quality improvement projects, while providing visibility throughout the organization.
  • REDUCES OPERATING COSTS