Implementing effective and comprehensive CAPA in a timely manner continues to be a major problem among medical device, pharmaceutical, and biological companies. The lack of follow-up and close-out are frequently mentioned. According to recent trends, approximately 30% to 50% of all citations are CAPA-related. Manufacturers following ISO quality standards must also ensure appropriate corrective and preventive actions are done to sustain quality and promote improvement within the organization.
To ensure compliance and quality, organizations must close the loop on risk and non-compliance and develop closed-loop systems that detect existing potential quality problems and facilitate rapid problem resolution and closure. While all organizations hope to avoid the root causes that necessitate corrective actions, reality dictates otherwise. Because defects, deviations, or any other gaps that trigger the need for a CAPA can come from a myriad of sources (documents, training, products, etc.), CAPA management has become the core process of a well-established compliance and quality program.
The automation of CAPA coupled with a multinational CAPA team ensures complete visibility when deviations, potential discrepancies, or non-conformances are discovered. As depicted in the figure below, CAPA is central to the implementation of an effective, closed-loop, continuous improvement process that focuses on prevention and quality.
Figure 1 – Closed-loop compliance process control system
A well-established CAPA management automated system should include the following key features to ensure compliance and quality:
The following current best practices are designed to help mitigate risk and holistically drive quality across today’s regulated organizations. The industry is evolving from the deployment of standalone CAPA systems to integrated compliance process control systems that treat CAPA as an integrated enterprise process. The following best practices are an excellent starting point to help avoid implementation problems and regulatory issues.
Ready to learn more? Book a free demo.
Head of Quality Assurance
Heidi leads Xybion’s Quality Assurance practice. She has over 20 years’ experience in designing and implementing quality assurance policies. Since joining Xybion in 2000, Heidi worked with several clients to design quality policies and ensure compliance. She is responsible to hosting Xybion customer audits. Heidi has a BA degree in Biology from The King’s College.