FDA Validation Support

We know how important FDA validation is and how it contributes significantly to assuring quality

FDA Validation Support

As a diversified engineering firm, KB Controls and Automation is one of the leading robotic assembly
and test systems integrator specializing in innovative industrial automation design. KB has been
building relationships and projects that last. Serving a list of clients with experience and expertise in
multiple industries.

Stage 1 – Process Design:
The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.
Stage 2 – Process Qualification:
During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.
Stage 3 – Continued Process Verification:
Ongoing assurance is gained during routine production that the process remains in a state of control.

A successful validation program depends upon information and knowledge from product and process development. This knowledge and understanding is the basis for establishing an approach to control of the manufacturing process that results in products with the desired quality attributes. KB Automation and Controls can help you:

  • Understand the sources of variation
  • Detect the presence and degree of variation
  • Understand the impact of variation on the process and ultimately on product attributes
  • Control the variation in a manner commensurate with the risk it represents to the process and product
  • Check faults, functionality and I/O