Developing a new medical device from concept to market can be a complex process. Design controls are an interrelated set of practices and procedures that are incorporated into the design and development process (i.e., a system of checks and balances) for a medical device. Design controls make systematic assessment of …
Current Good Manufacturing Practices (CGMPs) enforced by the FDA require that all manufacturing processes be validated. Validation ensures that controlling the inputs (i.e. parameters) within an acceptable range will consistently produce outputs (i.e. products) of acceptable quality. The current FDA view of CGMPs emphasizes a risk and science-based approach to …
Is your process not running consistently? Are some pieces of equipment requiring too much attention from maintenance and engineering? We all know how frustrating this can be – sometimes it feels like you’re running in circles. You also understand the importance of a structured approach to analysis, troubleshooting, and problem …
In the pharma industry, manufacturing operations are routinely in the pursuit of perfection. There have been a number of initiatives to foster this pursuit; Six Sigma, Kaizen, and many other efforts. All of them at their core are for the search for one thing: Process Optimization. They are looking for …
Are you thinking of designing, planning, installing, modifying, or validating a cleanroom? Kymanox can help you with that! We are experts in cleanroom engineering and can assist you with your cleanroom no matter if you are in the design phase, needing construction support, or validation. Our reputation has been built …
One of the most important elements of a Quality Management System (QMS) is the Corrective and Preventive Action (CAPA) system. The purpose of the CAPA system is to identify, investigate, and correct or prevent product and quality nonconformities or other undesirable situations. Corrective action is an action taken to eliminate …
