Remediation

Our PathWise consultants will work with your team to help remediate FDA 483 warning letters and other world regulatory actions using a five step, risk-based remediation process.

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PathWise

Consulting

5 Step Process

STEP ONE: Gap Assessment

STEP TWO: Planning

STEP THREE: Development

STEP FOUR: Implementation

STEP FIVE: Verification

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STEP ONE: Gap Assessment

PathWise will evaluate the compliance, effectiveness, and efficiency

of a systems current state, and prepare recommendations

for a future state.

STEP

1

GAP

ASSESSMENT

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STEP TWO: Planning

that outlines actions needed

PathWise creates a comprehensive project plan

to achieve future state objectives.

STEP

PLANNING

2

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STEP THREE: Development

PathWise helps develop process maps, SOPs, forms, training,

qualifications, or other applicable activities for approval,

prior to release and "go live".

STEP

3

DEVELOP

MENT

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STEP FOUR: Implementation

to implement the future state.

PathWise provides hands on expertise

STEP

IMPLEMENTATION

4

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STEP FIVE: Verification

Through a third party, we verify the system is

compliant, effective,

and efficient.

STEP

5

VERIFICA

TION

Compliant.

Effective.

Efficient.


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