Pharmaceutical Manufacturing Facility Validation

Chemical Manufacturing (NAICS 325)

The Challenge

When a major pharmaceutical firm required a massive influx of personnel to assist in the remediation of FDA quality issues, they turned to Frakes Engineering for support.

The Solution

Our firm provided 8,000 manhours of engineering services onsite, helping the customer address their regulatory compliance concerns.  Our Valdiation team worked along with the customers staff conducting GxP gap analysis, writing Validation documents and performing source code reviews on over fifty different systems.

This is just one of many solutions that Frakes Engineering has provided over the years.  If you have questions about this or other services that we provide, please feel free to contact us.

Additional Resources