Blogs #regulatory requirements
Demystifying Engineering Change Control in the Medical Devices
Engineering change control is a subset of change control that specifically focuses on changes related to product design, development, and manufacturing processes. It is a structured approach to managing changes in engineering documentation, product specifications, drawings, and other technical aspects.
The Power Trio: IQ, OQ, and PQ Explained
In the realm of product manufacturing and quality control, the verification and validation process plays a crucial role. Three key components of this process are IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification). In this blog post, we will delve into the significance of each phase and how they contribute to ensuring product integrity and regulatory compliance.