NEWSDETAILS 7th September, 2007 Intercell and Novatek.
PDA/FDA meeting, Sep 2007, Novatek International is pleased to announce that it is now an approved vendor under the Software Quality Assurance Audit of Intercell (Livingston, Scotland), one of the leading biotechnology companies in Europe.
Intercell's Software Quality Assurance Audit covers procedures and practices in developing, testing, installation, validation and supporting its software for laboratory information management system.
We like to welcome Intercell as our newest client joining the ranks of prestigious clients such as J&J, Pfizer, Schering Plough, Novartis, etc, in Four Corners of the world.
Intercell has chosen Novatek’s Environmental Monitoring solution to control activities and data within their extensive quality, and research and development divisions. Novatek International is pleased to welcome Intercell, Scotland to the ranks of other prestigious clients such as Novartis, Pfizer, Schering Plough, lifenet, Sanoffi-Aventis among many 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 Intercell:
Intercell AG is a growing biotechnology company which focuses on the design and development of novel vaccines for prevention and treatment of infectious diseases with substantial unmet medical need. The Company develops antigens and immunizers (adjuvants) which are derived from its proprietary technology platforms, and has in-house GMP manufacturing capability. Based on these technologies, Intercell has strategic partnerships with a number of global pharmaceutical companies, including Novartis, Merck&Co., Inc, sanofi pasteur, Kirin, Wyeth, and the Statens Serum Institut. The Company’s lead product, a prophylactic vaccine against Japanese Encephalitis has successfully concluded pivotal Phase III clinical trials. The regulatory process towards a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) has been initiated. The broad development pipeline includes a therapeutic vaccine for Hepatitis C in Phase II, a Pseudomonas vaccine in Phase II, partnered vaccines for Tuberculosis and S. aureus which are in Phase I, and five products focused on infectious diseases in pre-clinical development.
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
