Can STAT-A-MATRIX help with interpreting all of these changes and developing programs to address them?
STAT-A-MATRIX can help pharmaceutical and biotech organizations understand, develop, and implement quality process management systems compliant with FDA regulations and international harmonization guidance. We are uniquely qualified to help with these regulatory initiatives because we have worked with numerous FDA-regulated organizations to develop a broad range of quality systems that stress quality management, quality assurance, design control, and the use of risk management tools, in addition to the fundamental quality control requirements in FDA CGMPs. For example, the STAT-A-MATRIX 14-step implementation process develops a modern quality system with the necessary framework for building in quality from the drug product development phase, during the application of process analytical technologies in manufacturing, and throughout the drug product lifecycle. The STAT-A-MATRIX 14-step implementation process can also be used to strengthen or initiate Lean Six Sigma programs. This is sign
