hramchandani

Entries by Harsha
Comparison of Medical Device Standards

Whitepaper – ISO13485 & US FDA CFR 820 Comparison

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 …

Technology-in-the-hands

Embracing an electronic quality management system

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

Plan Do Check Act - CAPA

Maintaining Control of your CAPA system

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.