New software for particle size analyser meets requirements of the FDA rule and provides assurance that the system is validated for accuracy, reliability, and consistency
The all-new Confirm software was developed to address the many requirements specified by the 21 CFR Part 11 final rule published by the US Food and Drug Administration (FDA) to reduce time to market of new pharmaceutical products.
Combined with Micromeritics's IQ and OQ services, the user can be assured that the system is validated for accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
System access is limited to authorised individuals.
Secure, computer-generated, time-stamped audit trails are an integral part of the software program. Utilising a state-of-the-art CCD detector, Mie theory, and unique design and data reduction features, the Saturn DigiSizer 5200 automatically measures particle sizes ranging from 0.1 to 1000 micrometers in just minutes.
Optional features such as fully automated sampling, low-volume and micro-volume sample handling systems make the Saturn DigiSizer ideal for a wide range of production, research, and quality control applications.
