Holistic approach to data management for pharmaceutical manufacturers

PharmaIntegrity enables quick and easy detection and trend analysis of cleanroom contamination before problems occur.

September 25, 2018, Boulder, CO – Particle Measuring Systems (PMS) and Novatek International have formed a partnership to create the first fully integrated data management system for cleanrooms, ensuring compliance with legal regulations and product integrity. This combination allows for the rapid and straightforward setup of a fully integrated cleanroom monitoring and data management system.

"By combining PMS's reliable contamination monitors with our data management and trend analysis system, we can offer our customers a reliable, ready-to-use solution with high adaptability for long-term growth," said Sarah Alimirzaei, Director of Strategic Alliances at Novatek International.

All critical data is stored in a single system that connects global locations worldwide, making quality assurance data quickly accessible. It enables products to be introduced to the market easily, quickly, and in compliance with industry regulations, including 21 CFR Part 11, ISO 14644-1/2, and Annex 1 of the EU-GMP Guidelines.

"Particle Measuring Systems offers customers a unique complete package, including consulting services, particle and airborne microbial monitors, cleanroom monitoring systems, training and education, and now – through our partnership with Novatek – data management," said Giovanni Scialo, Vice President of Life Sciences at Particle Measuring Systems.