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Good People Working on Good Projects with Good Process

Case Study 2: Test Method Validation

Situation Client was a midst transferring manufacture sites from an out of state facility to Minnesota. During the transition period the clients customers asked for verification and validation activities to ensure the transfer resulted in quality products.
Frestedt Approach
  • Reviewed and updated manufacturing procedures during manufacturing transitions
  • Reviewed the clients internal validation procedures to develop validation test methods which would assess the performance of the final product
  • Reviewed associated production test methods
  • Completed requested procedures and delivered documents ahead of schedule
Results Frestedt Inc. delivered several test method validation protocols to the client using their development process to ensure continuation of their practices within their QMS. All documentation review and provided to the client was created in compliance with all parts of the clients internal QMS.

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