Even though, Medical Device companies are aware that they’re required to detect and react to non-conformance issues, there’s still a large percentage of FDA’s 483 warning letters in 2014 that cite Corrective Action / Preventive Action (CAPA) incident management deficiencies. Every medical device company needs to have an effective CAPA system in place to minimize their risk and to ensure FDA regulation compliance. Maintaining both high quality standards and strict regulatory compliance not only affects your company’s bottom line, but in the medical device marketplace can very well mean life or death for a patient using your product.
Maintaining an effective CAPA process on any ERP system can be challenging, if not impossible. Potential issues occur at every step of the CAPA process and normally requires a considerable amount of manual processes outside of your ERP system, Excel spreadsheets, and various paper documents to ensure the process is working correctly. All these manual processes exposes any company to excessive risk and potential 483 violations. Automated quality systems that work seamlessly with your current ERP system should be an important part of your compliance arsenal to help resolve non-conformance issues quickly and minimize your risk. This ability to quickly resolve customer complaints successfully is critical for any business in today’s competitive medical device marketplace.
Quality systems typically automatically capture detailed production and quality information from anywhere on the shop floor streamlining CAPA solutions and corrective actions. Good quality systems not only automates routing, delivery, escalation, and approvals of CAPA’s and all related documents, but also as required by FDA’s CFR 820 part 11 and 21, automatically updates your Device Master Records (DMR) and Electronic Device History Records (eDHR).
FDA regulations encourage medical device companies to harness the latest ID (21 CFR Part 801.20) and data collection technologies to improve their delivery systems. Specifically, FDA regulations (21 CFR Part 820) address electronic processes of printed materials used in production, product components, quality assurance, packaging, labeling, installation, maintenance and services. These procedures are targeted by the FDA because manual processes lead to endless paper trails and errors. Not only does the continued use of paper require larger physical storage space, it also complicates data retrieval, creating a labor intensive and extensive system. Quality systems also enables companies to improve their brand loyalty and customer satisfaction by continuously improving quality and responding quickly to potential incidents.
