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Quality is not a department it is a mindset and compliance is not optional. We work with companies, CAPA, Change Control Risk Management, Complaints Management Design Control. Oftentimes the role of the select few that have “Quality” as a component of his/her title. That is not the case Quality is the role of the entire company. Quality is a culture.

The process by which to achieve compliance to these requirements is different for each company. For example, large companies may need to prioritize geographically-different operations based on size/importance and implement systems accordingly. A smaller company may need to prioritize which elements of the quality system to implement first (e.g. work instructions, design control) in order to get in compliance quickly.

Making these types of decisions requires thought and planning because these decisions will affect the speed and cost of the total implementation, potential savings that could be realized through a quality system implementation and the level of comfort the FDA will have that you are implementing a compliant quality system.