QA Requirements - Test Requirements v. Test Plan v. Test Protocol Gap Analysis

The BSUBAS BAS Subject Matter Expert (SME) takes provides review and analysis;

• The Test Method Requirements analysis reviews the test methods required by the client quality system documents and by the industry best practices.
• The Test Method Requirements are compared to the Test Plan and Test Protocols in a “back and forth” manner to ensure all requirements are captured.
• Any deleted or added requirements, plans or protocols require documented justification.
• Deviations are identified for corrective actions.