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 …
Entries by Harsha
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.