How is the pharmaceutical manufacturing industry around the world expected to continue production during the COVID-19 pandemic? What control measures should be in place to help prevent or mitigate the potential adverse effects of …
Marketing medical devices at a global level can be a gruelling and onerous task when trying to achieve compliance to various differing regulations. FDA 21 CFR Part 820 compliance outlines Quality System Regulations for …
Electronic Quality Management Systems (eQMS) have gained increasing popularity within the healthcare industry over the last decade. The following diagram shows the various processes for which management, communication and workflows can be automated via the use of an eQMS
Often, companies find themselves inundated with open CAPAs. This is most commonly experienced in the aftermath of an audit, where the CAPA system is used to document the issues that are identified, the investigations, the execution of corrective and/or preventative actions, and finally the closures.
