The Environmental Monitoring Program will take Unither into the future with safe and dependable data storage and mining tools. Novatek International is pleased to welcome Unither to the ranks of other prestigious clients such as Forth Dodge (Wyeth), Gensia Sicor, J&J, Cangene, Schering Plough, Novartis and more, in the four corners of the world.
Environmental Monitoring Program is an application capable of capturing all environmental data in a 21 CFR Part 11 Compliant, fully validated system. It is envisioned for sterile and non sterile health care industries (Pharmaceuticals, Biotech, Chemical, microbiological) food and any other sterile environment based on the latest guidelines from, FDA, EU, ISO 14644-1 and PDA Technical report 13.
Data from viable and non viable monitoring, Water analysis, clean steam and compressed gases are securely captured and easily trended to ensure site "state of control". The investigation window allows the user to investigate Out of Specification "OOS" with capability to add any files such as picture, audio video, scanned documents etc to the report.
About Unither
United Therapeutics is a biotechnology company focused on the development and commercialization of unique products for patients with chronic and life-threatening cardiovascular, cancer and infectious diseases. In these segments, United Therapeutics is actively developing four technology platforms: Prostacyclin Analogs, Immunotherapeutic Monoclonal Antibodies, Glycobiology, and Telemedicine.
NEWS:
April 2012
Novatek’s NOVA-EM The Environmental Monitoring Data Management & Trending System Software – The Industry Standard
February 2012
West-Ward Pharmaceuticals, a subsidiary of Hikma PLC – Portugal, Germany & USA West-Ward Pharmaceuticals, a subsidiary of Hikma PLC has chosen Novatek’s microbiology environmental monitoring software program
