Validation, Audit, and Technical Management


PSC Biotech® provided validation services for Reflex UDI project for the client.

  • Area: Texas
  • Project Type: Quality Assurance 

About this Project


This project aimed to provide validation and Engineering support for the Reflex UDI Machine Qualification project.


PSC shall complete the following tasks as part of the validation and engineering support for the client, the key deliverables of this project included:

  1. Risk Assessment
  2. Functional Requirement Specification (FRS/FDS)
  3. Installation and Operational Qualification (IOQ)
  4. Development of Execution/ exceptions/ Reports
  5. Configuration Specification
  6. Trace Matrix (TM)
  7. Development of SOPs and relevant forms or documents.

PSC also supported the client with project management in the execution of this project.

Project Success

This project was completed successfully as per client specifications and in the expected time for completion.


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