A successful LIMS Implementation at a Large Multi National Pharmaceutical Company
NEWSDETAILS 7th August, 2007 Unither and Novatek
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.
Feb, 2010
APP Pharmaceuticals Goes Live with Novatek's Environmental Monitoring LIMS Software (NO-VA-EM).
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Dec, 2009 Montreal, Canada, Dec, 2009.
Novatek International, the pioneer of 21 CFR Part 11 compliant LIMS would like to announce that Solumed a subsidiary of 3M ...
Sept, 2009 Pyramid Labs, CA, USA and Novatek.
Novatek International, the pioneer of 21 CFR Part 11 compliant LIMS would like to announce that Pyramid Laboratories, CA, USA has chosen ...
July, 2009 JHP Pharmaceuticals and Novatek
JHP Pharmaceuticals choose Novatek International for automating their Environmental Monitoring and Quality System management processes ...
July, 2009 Medtronics, MN, USA and Novatek.
Novatek International, the pioneer of 21 CFR Part 11 compliant LIMS would like to announce that Medtronics, MN has chosen Novatek’s Stability LIMS software solution ...
4th Pharmaceutical & Biotech GMP Conference
Ensuring Patient Safety through Good Manufacturing Practices
February 21-23, 2010 | Dubai, United Arab Emirates
Fundamental Tools in Statistics for GMP Compliance
A Two-Day Case Studies & Workshops for Life Sciences Professionals
February 2-3, 2010 - Greater New York city Area, USA.
