Compliance Remediation

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Case Study

Compliance Remediation – CMP & Quality System Re-Build

For a medical device implant manufacturer, QualityHub provided a full quality system rebuild and remediation. The front-end of this project included baseline audits of their manufacturing sites in US and Europe. Based on gaps identified by FDA and the QualityHub audits, we created a Compliance Master Plan (CMP) that guided the project.

The CMP included interim controls, future state (a rebuilt quality system), and remediation activities. In parallel to the CMP work, we created FDA-483 proof books and coached the company on handling the next FDA inspection.

QualityHub brought in a Project Leader, Project Managers, Executive Coach, ex-FDA Mock Investigators, Team Subject Matter Experts (SMEs), and numerous Associate-level consultants to assist with the day-to-day work at the company, as well as the remediation work. The company passed their next FDA inspection.