Quality Systems Gap Analysis and Remediation

SITUATION

A market leading medical device company with a robust pipeline of Class II and III surgical devices recognized challenges in quality and delivery in their clinical organization and requested an organization-wide gap analysis.

SOLUTIONS

  • Halloran conducted interviews with all clinical functions and reviewed organizational and quality documentation to identify gaps.
  • Halloran developed a Gap Analysis Plan aligning corporate objectives surrounding quality and delivery with assessment strategy designed to provide comprehensive functional assessments, analysis of key procedures and assessment of gaps against global regulations and industry best practices.
  • Halloran delivered a detailed gap analysis report summarizing issues, risks, and potential avenues for remediation.
  • Halloran developed and implemented a remediation plan which included process development and documentation, organizational optimization, and improved training.
  • Halloran initiated a quality plan and governance process designed to identify and address future non-conformances and implement appropriate corrective actions.

VALUE

The Company received a detailed assessment of the organizational issues in a risk-tiered manner along with recommendations for a risk mitigation plan. The company subsequently engaged Halloran for remediation activities and quality document revisions. Remediation activities ultimately led to an enhanced culture of quality throughout the organization and a greatly improved compliance posture throughout the clinical organization.