Many current risk-assessment approaches are very detailed. 

As a result, few companies perform risk assessments
across all their systems, equipment and processes.

By contrast, the Risk-Based Validation Manager uses
a top-down, triage approach which makes
across-the-board assessments feasible.

Validation actions can then be selected
according to the relative risk of each system or process.
 

Stepwise refinement
 

Identifies highest-risk systems & processes by using a small number of questions to “filter out” lower-risk systems. Uses more questions in additional passes to successively narrow the focus.

Consistent questions
 

Asks users to answer risk-assessment questions, some of which are specific to the type of process or system and to existing or planned status. (These questions can be modified by administrators.)

Calculates risk
 

Calculates risk for each process or system, using the above answers along with built-in weighting factors and algorithms (that can also be modified).

Recommends risk-based validation actions
 

Selects validation actions (from customizable library) based on the assessed risk of the process or system.

Reports from database 
 

Stores the questions, answers, factors, and risk assessments for all processes and systems in a single database.  Creates reports on single or multiple processes and systems.

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