Audits

Which can be conducted in house, or at your suppliers and contract manufacturers. Where indicated, they may be performed against the requirements of US pharmaceutical and medical device regulations - Code of Federal Regulations Chapter 21, Parts 111, 211, and 820.

Deviation Investigations

Especially in determining root causes and communicating these to all employees throughout your organization. Too often, these individuals do not understand the reason for the requirements to conform to regulations. They only know what they are required to do, without understanding their role in the larger context of what the company is required to do and why, and in the company' business goals. When they understand how they fit into the larger picture, their level of compliance increases.

Corrective & Preventive Action (CAPA) Systems

Created in conjunction with the deviation investigation concept. When your employees understand their role in the organization' success, CAPA ideas come flooding out of them. Subsequently, you will need a system to control, funnel, and implement these ideas in a coordinated manner in order to better maximize business improvement.

Quality System Improvements

Guidance on adapting required changes and modifications within your organization in order to better achieve your business goals. Although we can help you implement sustainable improvement, we cannot do it alone. We can provide you the tools and systems, but you are an equal partner in the journey.