 |
Recommends validation actions
based on risk
|
|
-
Avoids unnecessary validation of
low-risk systems and processes
|
|
Reduces business and regulatory
risk
|
|
- |
Encourages a disciplined
approach to assessment and
remediation
|
|
- |
Focuses attention on a small
number of processes/systems --
those with the highest risk or
need for remediation or
gap-analysis
|
|
Provides a company-wide view of
all risk assessments
|
|
- |
Supports evaluation and
prioritization of risk across
all computer systems and
manufacturing equipment
|
|
- |
Provides senior management with
summaries and drill-down details
|
|
- |
Improves confidence that further
assessments are focused where
necessary
|
|
Reduces likelihood of FDA
“risk-based inspections”
|
|
- |
Provides the FDA with visible, documented evidence of
a formal, disciplined approach
|
|
Uses a
resource-efficient,
step-wise process
|
| |
- |
The brief, first pass can be
done quickly for each family
of systems
|
|
- |
Subsequent passes are
performed only where
indicated
|
|
|
