Six Sigma Logo System Integration, Computer Validation
and EPA Regulatory Service Provider
 

Who is Six Sigma Technology, Inc.?
Six Sigma Technology Inc. is a manufacturing software automation integration and validation company that follows the GAMP (Good Automated Manufacturing Practices). Our vision is to provide quality service in the areas of automation integration and GAMP in compliance to 21 CFR (Code of Federal Regulation) part 11 to pharmaceutical and food industries.

We develop graphical user interfaces (GUIs) that put the process/system control at the fingertips of the operator. From status monitoring and device control to historical trending and recipe management, we implement the most popular industry standard software for client/server applications or single workstations. We serve such industries as chemical, pulp and paper, pharmaceuticals, refining, and food processing. We comply with all FDA Current Good Manufacturing Practices (cGMP) in pharmaceutical manufacturing documentation. The GAMP Guide for Validation of Automated Systems in pharmaceutical manufacturing is the most widely used, internationally accepted guideline for the validation of computer systems. Six Sigma has GAMP qualified personnel who provide our clients with a validation life cycle for automation software development for the pharmaceutical and food and beverage industries. We also provide consulting in the following areas in compliance to GAMP procedures:

  • Good Clinical Practice (GCP)
  • Good Laboratory Practice (GLP)
  • Good Distribution Practice (GDP)

Our experience also includes services in the area of Environmental Regulartory Compliance. We specialize in water and wastewater treatment, and performing environmental audits in pharmaceutical industry.