Field notes from the front line of quality.
Practical guidance from Globiox SMEs — FDA readiness, auditing, CAPA, validation, and quality systems for regulated life sciences.
Staying Ahead: Navigating Timely Training and Version Control in Pharmaceuticals and Medical Devices
written by: Jenny Azarh In the dynamic world of Pharmaceuticals and Medical Devices, maintaining regulatory compliance and ensuring the highest standards of…
March 13, 2024Quality & ValidationChoosing the Right EQMS: Key Considerations in Quality Management System Selection
Written by: Steve Norris The terms “enterprise quality management system” (EQMS) and “electronic quality management system”(eQMS) are often used…
January 31, 2024Quality & ValidationEquipment validation is not process validation
Editor’s note (August 2026): On February 2, 2026, FDA’s Quality Management System Regulation (QMSR) replaced the Quality System Regulation, incorporating ISO…
June 11, 2014Medical DevicesDesign Control
Editor’s note (August 2026): On February 2, 2026, FDA’s Quality Management System Regulation (QMSR) replaced the Quality System Regulation, incorporating ISO…
August 14, 2013Quality & ValidationHigh frequency of CAPA related observations in warning letters
Editor’s note (August 2026): On February 2, 2026, FDA’s Quality Management System Regulation (QMSR) replaced the Quality System Regulation, incorporating ISO…
July 18, 2013Quality & ValidationDon’t let the user manual become the user
Over the years we have had many projects where users have asked us to qualify their laboratory equipment and validate commercial off-the-shelf (COTS) software…
June 12, 2013Quality & ValidationWhat happens when you can’t test a test?
Test Method Validation (TMV) is a critical part of ensuring quality for manufacturing. This highly specific aspect of validation involves proving that quality…
April 16, 2013Ready to get inspection-ready?
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