The comprehensive software and hardware solution enables a risk-based approach to environmental monitoring in controlled manufacturing processes in the life sciences industry, improving contamination control
Particle Measuring Systems (PMS), a global expert in sterility assurance, and Novatek International, the leader in regulatory compliant data management software, have entered into a global partnership providing a fully integrated and comprehensive software and hardware solution towards a risk-based approach for the environmental monitoring in controlled manufacturing processes.
"PMS is focused on providing complete sterility assurance solutions to the life sciences industry. The Nova-EM software is an excellent next step to our Facility Pro environmental monitoring system and provides our customer with the secure data management that they need to succeed," said Giovanni Scialò, VP of Life Sciences for Particle Measuring Systems.
This integrated solution helps companies identify contamination in their production processes before it occurs. With the ability to preemptively correct a problem it is easier to achieve and maintain a state of control. This helps maintain consistent product quality and reduces the costly risk associated with loss of product and product recalls.
Nova-EM environmental monitoring software meets increasingly stringent regulatory requirements for environmental monitoring, data management, and data integrity while eliminating the many challenges of paper based processes.
The integration with Particle Measuring Systems enables people to effectively analyse and preemptively visualize possible sources of contamination in all areas associated with pharmaceutical production including air, surfaces, utilities, and personnel. Automated data acquisition from both continuous and portable devices, centralised data repositories and specialised integrated analysis tools are the ingredients to the most advanced integrated solution available on the market.
“With Particle Measuring Systems as our partner we are excited to continue Novatek’s legacy of providing innovative turnkey solutions to our customers,” said Sarah Alimirzaei, Director of Strategic Alliances for Novatek International.