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 …
Process Validation
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 …
Process Troubleshooting
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 …
Process Optimization
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 …
Cleanrooms and Hoods Engineering
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 …
Corrective and Preventive Action (CAPA)
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 …