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Risk Management and Risk-Based
Validation are coming of age,
as the
following quotes indicate.
General frustration: Too much
validation!
| |
“How can we
get off the train of 1,000-page
protocols without violating all
the policies we’ve put in place
over the years?” |
ISPE: Risk-based Qualification for
the 21st Century
| |
“The FDA and
international community have
shifted to a risk-based approach
to compliance.” |
FDA: Risk-based Inspection
initiative
| |
“If a
company shows they can manage
risk better, that will reduce
the chances of their being
inspected.” |
European Medicines Agency: Quality
Risk Management
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“Effective
quality risk management can
provide regulators with greater
assurance of a company’s ability
to deal with potential risks.” |
But
implementing Risk
Assessment is not easy
Risk Assessment
initiatives are repeatedly “deferred”
|
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Methods
appear to be overly-detailed and
time consuming |
|
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For
multiple systems, the challenge
seems overwhelming |
|
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Assessment
projects are tough to define:
where to start? |
|
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More-familiar initiatives
receive a higher priority
|
Risk Assessment initiatives are
incomplete or aborted
|
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Overly-detailed
methods overwhelm users |
|
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Methods are
inconsistent |
|
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No management
view of assessments |
|
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No central
records, so re-assessments start
from scratch |
Lack of a Risk Assessment context
causes unnecessary costs
|
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Remediation
strategies demand unfocused,
unnecessary detail |
|
- |
Validation
employs a “boil the ocean”
approach |
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