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