It is easy! It takes a few days; our partners work with you to create your compliance profile using a comprehensive proprietary auditing questionnaire combined with your specific auditing questionnaire. Based on your input using an advanced Projection Algorithm, assessing for each specific sites the compliance related risks. We then provide the site’s team with potential compliance deficiencies prioritized by the order of importance, to avoid costly consequences of incompliance.

Here are the 3 key steps to implement FDAAWARE:

1. Create a site with FDAAWARE

  • Site attributes and site Information are surveyed
  • Site Questionnaire (Self Compliance Auditing)
  • Algorithm Setting (Parameters) & Run
  • Review Results and Make Adjustments

2. Create Projects

  • Identify Projects to address the Algorithm results
  • Project Tracking / Progress using FDAAWARE FDAAWARE Reports and Dashboard

3. Reports and Dashboard

  • Review Algorithm, Report Results and Run "What if" Analysis (i.e., Changing Algorithm Parameters and Questionnaire)
  • Monitor Progress and Recent Events using FDAAWARE Dashboard
    FDAAWARE offers along with its implementation partners a range of professional services including:
  • Support of FDAAWARE platform implementation including workshops to facilitate questionnaires and identified critical risk areas
  • Develop a cost effective road map for risk mitigation improvement
  • Consulting support in areas such as writing procedures, process validation, investigation and root cause analysis, CAPA, risk evaluation and more
  • Assessment of company compliance risks in comparison with competitors
  • Third party auditing using FDAAWARE by identifying potential risk areas and developing mitigation plan
  • Industry trends and reports

With FDAWARE you will be able to establish a continuous improvement process by addressing the top compliance risks, input back to FDAAWARE the progress and run the algorithm. FDAAWARE will provide the team the next key risk areas and this process will continue to further reduce the compliance risk and improve the overall site and company compliance level.

The illustration shows the flow from responding to the questionnaire, running the algorithm, having the compliance team set actions / initiatives to mitigate the key risk’s areas, and back to the questionnaire to report the improvement (reduce risk exposure). Once the risk is reduced, the algorithm will point out the next challenges and repeat the same process.

We work with clients to create their compliance profile using a comprehensive auditing questionnaire and structure align with the 483’s observation and CFR section. This information in conjunction with an advanced Projection Algorithm, assessing compliance risks for each specific site. We then provide the site’s team with potential compliance deficiencies prioritized by the order of importance to avoid costly consequences of incompliance.

  1. PDF / IMAGE / TXT
  2. Processing the
  3. Questionnaire, site profile
  4. Algorithm
  5. Reports / KPI
  6. Remediation Plan

License Options

In order to accommodate the diverse needs of various companies in terms of size, geography and stage, we are offering 3 different licenses for FDAAWARE:

  1. Silver: provides entry level for FDAAWARE platform to improve overall visibility, awareness and readiness for upcoming inspection
  2. Gold: aimed at mid-sized companies that need additional functionalities such as comprehensive auditing module, project tracking and advanced reporting capabilities
  3. Premium: provides ultimate access to FDAAWARE with robust algorithm, additional reports, dashboard, "What if" analysis and notification capabilities