Once a quality system is in place, manufacturers must conduct routine audits to ensure their system is compliant and effective.
Services We Offer
- Perform mock FDA inspections to assess QSR compliance
- Perform supplier audits; reducing your internal cost by outsourcing this requirement
- Perform internal audits; reducing your internal cost by outsourcing this requirement
Our Integrated Approach
Once a quality system is in place, manufacturers must conduct routine audits to ensure their system is compliant and effective. Without regular monitoring, there may be a reduction in product quality or a lack of process improvement, resulting in either a possible loss of third-party certification or FDA enforcement actions. MCRA’s experts can assess your compliance and prepare you for FDA inspections and notified body audits to keep you in compliance.
