Getting the Root Cause Analysis (RCA) right is at the soul of the implementation of an effective Corrective and Preventive Action (CAPA) program.
Design History File (DHF), Technical File and Design Dossier are important regulatory documents for a medical device. Design Control and Design History File are regulatory documents for medical devices in the FDA, while the Technical File and Design Dossier serve the same purpose for the EU’s regulatory body, the MDD. The Design History File The […]
Lineament analysis in geological exploration The existence of efficient and cost-effective methods that help to identify prospective targets that are related to or are influenced by tectonic structures is not common knowledge among professionals in the field of geological exploration. The right sampling and Quality Assurance/Quality Control (QA/QC) procedures are essential in all aspects of […]
The major challenge for most laboratories is having to develop and implement a functional Quality Management System (QMS) that not only complies with the management and technical requirements of the ISO/IEC 17025:2005 standard, but also meets the laboratory’s needs. This is why QMS is considered the soul of the ISO/IEC 17025:2005 standard. A highly meaningful […]
With the ISO making the final version of the ISO 13485:2016 standard available; it is now up to companies to start planning ways of implementing it. The major area in which it differs from the earlier version (of 2003) is in the extent of its alignment with the FDA’s Quality Management System (QMS) requirement. Although […]