A well-defined corrective and preventive action (CAPA) process is intended to identify problems, understand root causes, resolve issues, and take corrective action to prevent the recurrence of those problems. While the results are well worth the effort, designing and implementing a good CAPA process comes with some challenges. Here are some of the most common problems we see when companies are struggling with their CAPA processes.
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For many companies in FDA regulated industries, including pharmaceuticals, medical devices, labs and life sciences, compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a critical requirement.
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Pharmaceutical companies have seen several new trends emerge as a result of COVID-19, however, four top trends standout among the rest. To meet current challenges and to stay ahead, pharmaceutical companies are focused on enabling business agility, operational resilience, risk mitigation, and utilizing a remote and distributed workforce.
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A Quality Management System (QMS), is a set of processes that are implemented to ensure that business leaders meet FDA, ISO, and other global GxP regulatory requirements to help deliver better and safer products and to increase productivity. A successful QMS should be configurable and adapted to meet the needs of your business, including manufacturing, medical device services, aerospace, pharmaceuticals, nutraceuticals and so many more.
But what should I look for in a Quality Management System?
An effective QMS framework not only offers advanced analytics, to help better understand data, it enables users to make more informed decisions and improve productivity and can be properly executed if your business has these 8 robust Quality Management System apps.
Managing NonConformance (NCM)
Managing NonConformance (NCM) is an integral part of an organization’s continual improvement plan. Intellect’s QMS Platform enables organizations to capture, track and maintain accurate, auditable nonconformance records through a centralized database to have transparency for departments, sites, or locations. This allows organizations the ability to exceed audit, nonconformance, and corrective and preventive action requirements of common standards including ISO 9001, ISO 14001 and OHSAS 18001.
Topics: Document Control CAPA QMS Risk Management
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It is surprising how many companies today are solving their need to customize their Quality Management Software by modifying source code. It is understandable why a company may want to customize a software to meet its unique business and quality processes. However, software platforms have evolved so much that there shouldn't be a need to change or add code to the vendor platform. Not only does this require expensive development skills and expertise, it also means that the company can no longer receive vendor upgrades to their platforms as they have branched out with their own custom solutions.