SYSTEMATIX Validation for Automation

At SYSTEMATIX, we understand the importance of quality documentation when commissioning an automated assembly and test system, and have methods that focus on the areas that are most critical to quality.

quality documentation

Installation Qualification (IQ)

SYSTEMATIX offers a comprehensive Installation Qualification (IQ) documentation package for the automation which meet both Health Canada and FDA requirements.  The validation protocol outlines test cases which verify the critical elements in the Design Specification (SDS) are met.  We are able to customize and adapt documentation to support your requirements. 

Operational Qualification (OQ)

SYSTEMATIX also offers a comprehensive Operational Qualification (OQ) documentation package for the automation which meet both Health Canada and FDA requirements.  The validation protocol outlines test cases which verify the critical elements within the FRS include software validation.  We are able to customize and adapt documentation to support your requirements. 

Contact us to request samples of our documentation.


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