Why is the business named Lean RAQA Systems?
- At Lean RAQA Systems, we have a passion for creating quality systems that are in essence “lean” meaning the system is easy for clients to use, follow, and maintain. If a quality system is unnecessarily bulky or complex, it is tough to maintain compliance, exposing the company to business risks by creating daily resource burdens and compliance issues during inspections.
- What does “RAQA” mean? If you don’t know what RAQA stands for and you are making medical products, it means your company needs our services! Seriously though, RAQA stands for Regulatory Affairs and Quality Assurance and is a common abbreviation in the medical device community.
- Even the FDA thinks RAQA solutions must be lean:
- Lean RAQA Systems’ clients know they can not afford an overly burdensome Quality Management System from a compliance perspective or a business perspective!
- What’s in a word? The word “Lean” means so many things that capture an element of Lean RAQA Systems’ vision.
- No waste, no fat, no excess
- Lean manufacturing is a business model and collection of tactical methods that emphasize eliminating non-value added activities (waste) while delivering quality products on time at least cost with greater efficiency. Lean RAQA Systems is a nod to this industry practice developed by the godfathers of quality that has stood the test of time.
- Lean RAQA Systems’ goal is to eliminate waste and non-value add activities in our client’s regulatory and quality systems. By providing simple solutions to complex problems, Lean RAQA Systems’ customized services equip clients to agilely navigate complex regulatory requirements while also meeting business needs.