The FDAAWARE Platform includes several modules:

The high priority module provides the user with the most up-to-date summary of recent 483s, Observations, Warning Letters, EIR, Inspections and more. From that module you can access each one of these records in one click.
The dashboard provides an overview of the top risks by quality systems, area, by CFR Section; it shows industry trends and illustrate via a Pareto the site specific TOP 10 risk areas.
My daily view allows a quick access to various searches of 483w, recall, inspections and more. The user can search by company, investigator, regions and can select Warning letter, EIR and more. From that module, users can down load the 483s in their original form or with the added information as quality system, area, CFR Section connected to the observation.
This proprietary module provides the user with a pre-defined questionnaire all connected to the CFR sections and can show the number of occurrences of each CFR section associated with the question; the user can create its own question and upload from excel once comply with the same FDAAWARE structure. This module also includes 3rd party questionnaire and a full notification capabilities regarding 3rd party vendors receiving 483s, inspections, recall and more.
The Project tracking is used to follow up on actions resulted from the questionnaire, algorithm run or general actions that need to be tracked and for the user convenience, we have provided the platform to do it within FDAAWARE instead of elsewhere. The user can select the trigger for the action and follow up on the progress.
This is the most critical component in risk projection; it includes a configurable algorithm that helps our users to select their preference i.e., give more weigh for 483s sited in India, provide additional emphasis to more recent 483s and more. Once the questionnaire is filled, the user can run the algorithm and see the top risk compliance areas; the user can change the parameters and run again and see the impact.
FDAAWARE offers dozens of reports off-the-shelf capturing critical information associated with 483s, recall, keywords, investigator information and statistic, trends and a lot more. read more