In response to FDA-483, the Global Medical Device company engaged with RCM to undertake the assessments and gap analysis…
OBJECTIVE
In response to FDA-483, the Global Medical Device company engaged with RCM to undertake the assessments and gap analysis of quality systems and develop a remediation plan and response to the FDA findings.
Initial Goal:
- Assess, document and communicate the current compliance state of all manufacturing lines.
- Identify the compliance gaps and necessary remediation action.
- Execute the validation/remediation effort for 200+ systems.
SOLUTION
RCM provided four highly effective delivery teams consisting of a team lead, validation engineers, quality engineers, technical writers, and regulatory experts for four distinct product lines which manufacture over 25 different final product configurations. The teams were subject to a demanding timeline and challenging environment and were responsible for:
- Executing and documenting the regulatory assessment of the systems and the facility in scope and identifying the gaps and remediation activities.
- Defining and implementing the compliance solutions to meet Form 483 demands. The implemented solutions included the full re-validation of all product lines, as well as full facilities validation gap analysis.
BENEFITS
- RCM delivery was the defining force behind the Client gaining control of its regulatory and quality landscape and re-establishing positive relationship with FDA.
- RCM provided the Client with accurate project scope, resourcing and timetable, allowing the effective project execution.
- RCM specialists met the aggressive project compliance, quality, and delivery goals.
- The unique approach of deploying resources with unique expertise in the Client product lines allowed for a highly productive partnership between RCM consultants and Client personnel.
Key Project Elements
Validation & Remediation Action
Regulatory Assessment
Compliance Solutions
Gap Analysis
Regulatory & Quality Control