Holistic approach to data management for pharmaceutical manufacturers

Posted: 26 September 2018 | | No comments yet

PharmaIntegrity makes it quick and easy to identify and trend cleanroom contamination problems before they occur…

Pharma Integrity Graphic

Particle Measuring Systems (PMS) and Novatek International have partnered to create the first fully integrated cleanroom data management system, PharmaIntegrity, to securely meet regulatory requirements and ensure product integrity. This combination allows pharmaceutical manufactures to quickly and easily set up a fully integrated cleanroom monitoring and data management system.

“By combing the long-term reliability of PMS contamination monitors and our data management and trending system, we can offer our customers a trustworthy plug n play solution that is very adaptable for long-term growth”, said Sarah Alimirzaei, Director of Strategic Alliances for Novatek International.

All critical data is secured in a single system that connects global sites worldwide, making data readily accessible to the Quality Assurance department. This makes product releases easy, quick and compliant with industry regulations including 21 CFR Part 11, ISO 14644-1/2, and EU GMP Annex 1.

“Particle Measuring Systems uniquely offers our customers a complete solution package, with advisory services, particle and microbial monitors, cleanroom monitoring systems, training and education, and now, through our partnership with Novatek, data management”, said Giovanni Scialo, VP of Life Sciences, Particle Measuring Systems.