Beaufort, LLC’s quality assurance (QA) team has the in-depth experience and operational capabilities to implement an effective design control program for your new products. Our team works closely with your research and development group to ensure that all products are engineered, designed and developed in line with all commercial regulatory requirements. We then help transfer product knowledge and technical requirements throughout your operational functional areas for a successful product launch.
Our capabilities include:
Planning and execution of design projects
To successfully execute a design project, we review outcomes, reach consensus and ensure management review and approval. We also incorporate data and requirements from departments throughout your company—including marketing, sales, regulatory affairs, and purchasing—to identify and solve potential problems early in the process.
Design input/output verification and validation
We work with you to develop compliant protocols to validate and verify the user and functional requirements of any new design to ensure that output continues to meet input requirements. We then incorporate this information into the Design Master Records.
We use the Design Master Records and our comprehensive knowledge of your new product to efficiently transfer new designs from R&D to the manufacturing team. We also can continue working on the project to ensure that the final product meets the original design protocols.
We help perform risk analysis at key intervals of the project and mitigate any identified risks in a compliant manner.
Safety and environmental control requirements
As we work on your design, we ensure that all safety and environmental control requirements are built into the project from the beginning.
Our design control methodology incorporates decision trees and implementation steps that follow your control requirements. We also obtain and document management approval of all key technical/procedural changes.