BUSINESS DRIVERS

Key Features & Benefits:

  • Proactive Compliance: Facilitates compliance awareness and encourages a preventative approach, helping companies avoid costly penalties and reduce compliance risk
  • Extensive Database: Includes all FDA 483 inspection reports that were published by the FDA the past 15 years, enabling comprehensive historical insights.
  • Conversational Search: Users can query the database naturally, asking questions and receiving precise, context-aware answers.
  • Integrated Modules: Bundled with Smart-QC & Smart-QA, providing a full ecosystem for quality and compliance management.
  • Ask any questions related to your area of interest (e.g., FDA 483 trends, specific regulations, observation categories).
  • The system will:
    • Return the top 10 most relevant answers based on your query.
    • Provide immediate access to the most relevant FDA 483 observations.
  • Users can:
    • Export all related FDA 483s
    • Download a complete Excel export of all associated observations
  • Select “Get More Details” to:
    • View all underlying observations
    • Drill down from highlights to full inspection details

Companies are searching for a focused and efficient approach to address their compliance challenges, reduce their exposure and mitigate compliance related risks while facing:

  1. LIMITED Resources
  2. LIMITED Time
  3. LIMITED Budget

FDAAWARE has developed the ONLY cloud based risk management platform fully integrated with FDA FOIA gathering compliance intelligence to reduce likelihood/severity of 483. We have inspections information conducted for the past 10 years; the most comprehensive 483s / Recall / Warning Letters / EIR database in the industry. (Over 40,000 inspection records, more than 18,000 483s Records, 16,000 Recalls and more than 2,000 FDA Inspectors statistic). FDAAWARE is using a unique algorithm, combined with your inputs to identify potential risk areas; we will help you significantly reduce your compliance risk, and better prepare your team for an upcoming inspection.

FDAAWARE ENABLES COMPANIES TO MINIMIZE COMPLIANCE RISKS AND MANAGE IT END TO END.

  • FDAAWARE enables its users to, project their compliance risks by leveraging current and historical 483s, recalls and warning letters.
  • The usage of a company profile is used in conjunction with an advanced Projection Algorithm to assess specific sites and overall company compliance related risks, providing the site’s team with potential compliance deficiencies sorted in the order of importance. This helps reducing the overall cost and speed in identify and resolve compliance related risks
  • Trending reports are pushed to the compliance team, centralizing their focus on up-to-date FDA trends observed in their country, specific industry, region etc., creating a continuous improvement process. This is a key in reducing the overall company cost and resources and increase the added value to the company DO MORE WITH YOUR TEAM
  • Fully integrated risk management platform with FDA CFRs for Drugs, Biologics and Devices to effectively manage the compliance risk with limited resources.
  • Built-in Project Management module to optimize compliance mitigation efforts and full transparency.