A Protection and Control (P&C) design package for a typical substation includes a number of interrelated drawings, including one-line diagrams, schematic diagrams, wiring diagrams and interconnection ...
Design controls are not being used as an aid during medical device product development. Design controls are being viewed as a checkbox item — something you have to do, and seldom something you want to ...
Recent FDA enforcement trends (including 2013) reveal that both design control and Corrective and Preventive Action (CAPA) systems are critical elements to sustain FDA inspections. Device ...
When it comes to process-control systems, reliability is crucial and failure can be costly or dangerous. A combination of good design practices, component selection, and testing can enhance ...
Tell us about the control strategy you've implemented with AstraZeneca and its external partners. Over the last year, we worked to improve our control strategy for drug delivery devices. Our goal was ...
Batch remains advantageous for development, variable demand, and bounded risk, benefiting from natural hold points, simpler investigations, and lower upfront capital, despite longer lead times and ...