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QUALITY ASSURANCE

Quality Program Management services and consulting

  • Source surveillance, inspection, and third-party representation.

  • Quality Plans / Inspection and Test Plans development, author, and reviews.

  • History Docket review and acceptance.

  • Corrective and Preventative Actions (CAPA) / Root Cause Analysis (RCA) / significant event analysis and consulting.

QUALITY CONTROL PRACTICES

Consulting and oversight services for the application of Quality Control activities.

  • Test methodology selection, application, and procedure development.

  • Training, qualification, and certification of QC personnel.

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