Custom Assembly Automation/Process Equipment

Commissioning and Validation for Life Science Projects

As leaders in automation development, DT Engineering and Sterling Engineering provides comprehensive equipment validation and process automation services assembly systems. Our custom solutions can be tailored to innovative industries, such as life sciences automation, medical manufacturing, and pharmaceutical production.

This internal validation expertise ensures full compliance with FDA regulations, offering a complete GAMP®5-based qualification package, which includes:

  • Design Qualification (DQ)

  • Software Qualification (SQ)

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

 

Expert Equipment Validation for Medical Device Manufacturing

 
 
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With deep knowledge in medical device manufacturing, DT Engineering, in partnership with Sterling Engineering, ensures your automated systems meet regulatory expectations. Our validation team has specialized expertise in assembly processes of medical devices. Our equipment validation services provide the documentation successfully required to meet FDA Equipment regulations of medical devices and pharmaceutical automation systems.

 

Seamless Validation to Meet FDA Requirements

When partnering with DT Engineering and Sterling Engineering you’ll reduce your time and resource investment, while capitalizing on our knowledge and expertise in Life Science equipment. We can provide commissioning assistance of equipment for SAT/FAT and assembly process equipment validation. Our documentation package includes: DQ, SQ, IQ, and OQ. We have deep experience in executing assembly validation processes to help meet FDA requirements. We specialize in the validation of assembly equipment used in:

  • Medical device automation

  • Pharma automation systems

  • Industrial biotechnology applications

We can provide commissioning assistance of equipment for SAT/FAT and assembly process equipment validation. Our equipment and process automation validation documentation package includes: DQ, SQ, IQ, and OQ. We have deep experience in executing assembly validation processes to help meet FDA requirements.

 

Comprehensive Qualification Documentation Delivered

Whether you're launching a new system or upgrading an existing one, DT Engineering and Sterling Engineering ensure compliance with FDA and GMP regulations through validated processes and thorough documentation. Trust us to support your journey through every stage of the equipment validation lifecycle in life sciences automation, pharmaceutical production, medical manufacturing, and industrial biotechnology. Contact our knowledgeable team to learn more.