Corrective Action & Preventative Action (CAPA) is one of the key processes within an organization that comes under the umbrella of regulatory compliance. This process should be the first proactive prevention of deviations and the systematic processing for capturing; tracking and correcting deviations once they are identified and occur. Besides adhering to prescribed regulatory requirements, it is generally recognized as a good business practice to follow. In today’s competitive market, our clients’ consumers are calling for a constant improvement in the quality of product or services. Since over two thirds of the 483 citations historically issued by the FDA are related to both Laboratory and Corrective Action & Preventive Action (CAPA) processes, the importance that regulatory inspectors place upon these processes and technological solutions to support these operations is apparent.

Whether the process includes Six Sigma DMAIC (Define, Measure, Analyze, Improve and Control) or the utilization of electronic systems such as Sparta’s Trackwise or NetRegulus, we have extensive experience designing, developing, validating and implementing related processes and systems. Our consultants have both operational and compliance expertise, and act as team leaders, and knowledgeable partners, to support our client’s objectives.