Corrective and Preventive Action (CAPA) is a crucial component of any quality management system. It is an essential process that organizations use to identify, investigate, and solve problems that arise within their processes. In the context of the medical device industry, an effective CAPA process can mean the difference between life and death for patients. […]
Introduction Virtually every company, regardless of the industry, conduct its activities under set standards, guidelines, and regulations. In some cases, these guidelines detail internal procedures that must be adhered to in order to ensure the company’s product/services keeps meeting the standards considered satisfactory to the consumer. In other cases, these guidelines are prescribed the external […]
ISO 9001 certification is a globally recognized standard for quality management systems. To achieve and maintain this certification, organizations must have a robust document control system in place. Document control software is a critical tool for companies that are ISO 9001 certified or are working towards certification.
Document control software is a tool that helps organizations manage their documents efficiently and effectively. It is used to track, store, and manage various types of documents, from simple text files to complex technical drawings. With the growing need for organizations to maintain accurate and up-to-date records, document control software has become an essential tool […]
Non-conformance management refers to the process or guidelines involved in identifying, documenting, and addressing issues pertaining to non-conformance. This process is crucial to minimizing the impact of non-conformances on an organization’s operational output, reputation, and by extension, customer health. FDA-regulated industries, such as medical devices, life sciences, and pharmaceuticals are especially prone to non-conformance incidents. […]