We help companies design and refine quality management systems that dramatically improve outcomes. We blend creativity and logic to explore processes, connect the dots, and spark epiphanies.
We offer the following services tailored to your goals, challenges, industry sector, and regulatory status:
- Strategic planning for quality and compliance as well as execution
- Quality systems and Pharma GxP auditing, evaluation, and gap analysis | Mock Inspections
- Process development, improvement, and redesign
- Inspection/Audit Readiness Training and Consultation
- Management Training and Coaching on Quality Management Systems
- Employee Training on Quality Management Systems
We have global experience in the following industries, both in manufacturing and non-manufacturing divisions:
- Medical Device
We have the expertise and experience to help companies in many industries. Call us to discuss how we can help you.
Interesting Fact: Where applicable, we use art and the art process in our training programs as an analogy to help employees understand how attitudes and mindset in the face of chaos, problems, or crisis inform decision making and success. There is a deeper reason why art imitates life.
We believe in the common sense, risk-based application of proven quality management concepts. These concepts can be applied in any industry, including both manufacturing and non-manufacturing divisions.
The key is understanding the business, goals, and internal and external customer expectations. Then using that knowledge to make decisions and design and implement meaningful solutions.
Positive outcomes include:
- Increased efficiency
- Improved compliance and audit/inspection results
- Improved organizational culture
- Increases to bottom line results
- And much more
We help Fortune 500 companies assess, strategize, design and implement proven quality management concepts and methodologies to define gaps, inefficencies, and compliance risks. We apply common sense, risk-based approaches that meet the specific needs and challenges of your industry.
We understand the challenges of highly regulated industries as well as the challenges with using vendor that operate in the non-regulated business arenas. We use our expertise and experience to help design and implement appropriate solutions for vendor and supplier companies, while maintaining and strengthening client/vendor relationships and expected compliance profiles.
We help start-up, growing, and established businesses across industries understand, strategize, design, and implement proven quality management concepts used by Fortune 500 companies to ensure product quality and customer satisfaction as well as streamline processes, reduce costs and improve overall outcomes.
We help you identify, map, and evaluate your "as-is" processes to understand how to gain key efficiencies, stop frustrations, and improve outcomes. We also help companies definie and document key processes to proactively ensure consistency, particularly in anticipation of growth. Growth is fantastic! Be ready to ramp up!