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.
5 Step Process
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 TWO: Planning
that outlines actions needed
PathWise creates a comprehensive project plan
to achieve future state objectives.
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 FOUR: Implementation
to implement the future state.
PathWise provides hands on expertise
STEP FIVE: Verification
Through a third party, we verify the system is