FDA’s focus on vendor, supplier, and contract manufacturer compliance is tightening. Increased regulatory scrutiny has placed a greater emphasis on the importance of auditing the quality systems, practices, processes, products, and documentation of all third party providers.
The supply chain is only as strong as its weakest point. To protect yourself and your stakeholders from the consequences of recalls, seizures, injunctions, and other enforcement actions, it is critically important to identify and remediate all compliance issues present in your outsourced operations through comprehensive audits and corrective actions conducted by experienced quality professionals.
Our certified, experienced auditors plan, schedule, and execute vendor/supplier quality management audits to identify areas of conformance and nonconformance with applicable global regulations. Following assessment, our experts provide a detailed report including all observations, deficiencies, and a risk-based corrective action plan for improvement.
With an enhancement plan in place, our quality professionals will work closely with you to provide recommendations, resolve compliance issues, track corrective actions, and communicate the status of resolutions with company management. This comprehensive approach to vendor/supplier quality management strengthens your vendor/supplier relationships while ensuring your products are of the highest quality through a quality system that is compliant and efficient.
Our vendor/supplier auditing services include: