We Develop Visual Inspection methods that are defendable to auditors from world’s agencies. Our attention to detail had proven to minimize the human inspection variability by addressing important control measures and as such lowering variability in the inspection process.
Our focus engages in evaluating, implementing or enhancing Compliance and Quality Assurance programs within new or existing facilities for International Regulatory.
Our approach to continuous process improvement is a knowledge-based approach. For each phase of the Define, Measure, Analyze, Improve, and Control (DMAIC) process, we provide questions that must be answered in order to deliver critical knowledge.
Biothermal is a validation service company that provides commissioning and qualification for facilities, utilities, and equipment/ validation services to pharmaceuticals, biotech, and medical device companies. In addition to control system qualification, our services expand from engineering (C&Q) to scientific validation (ex. cleaning and process validation) to Lean Sigma manufacturing services to include training.
We use the combination of Six Sigma methodology with Lean Manufacturing Tools and Techniques to provide progress and reliable results.
Our approach to continuous process improvement is a knowledge-based approach. For each phase of the Define, Measure, Analyze, Improve, and Control (DMAIC) process, we provide questions that must be answered in order to deliver critical knowledge. These questions help leaders, Black Belts and Green Belts think critically and provide a pull system for the use of the statistical tools and techniques.
We strive to support the Manufacturing, Packaging, Technical Services and Process/Packaging Engineering Staff in pharmaceutical process validation, process control, optimization, and automation to obtain optimum operations that result in efficient, cost effective compliance processes.