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NEWS DETAILS

JHP Pharmaceuticals and Novatek


July, 2009

Montreal, Canada, July, 2009.

JHP Pharmaceuticals choose Novatek International for automating their Environmental Monitoring and Quality System management processes.   Novatek International Environmental Monitoring (NOVA-EM) software and Quality System Management (NOVA-QSM) applications will take JHP Pharmaceuticals, MI, USA into the future with safe and dependable data storage and mining tools, said Mr. Parsa Famili, President of Novatek International. We are delighted to welcome JHP Pharmaceuticals to the ranks of other prestigious clients such as Lonza, Forth Dodge (Wyeth), Cangene, Schering Plough, Holliater Stier, Unither Pharmaceuticals, LifeNet, Lifecore and hundreds more, in the four corners of the world.

Environmental Monitoring Program (NOVA-EM) 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 powerful trending window as well as the dispersion maps and Management Console allows management and users view the status of each location (facility, department, room, location). The investigation window allows the user to investigate Out of Alert and Out of Action results with capability to add any files such as picture, audio video, scanned documents etc to the report.

Quality System Management (NOVA-QSM) improve quality and reduce costs by centralizing and integrating all quality processes, including management and reporting of deviations, customer complaints, supplier quality, internal and external audits, change control, corrective and preventive actions (CAPA), preventive maintenance and calibration, training management, document management and others.

About JHP Pharmaceuticals,
JHP Pharmaceuticals, located in Parsippany, New Jersey, is an integrated specialty healthcare company that specializes in sterile injectable products. JHP manufactures and sells brand aseptic injectable pharmaceuticals in hospital and clinical settings and provides contract manufacturing services for global pharmaceutical companies. JHP's own product portfolio includes leading diagnostic, women's health and anesthesia products. All products have a long track record of "gold standard" service and are at or near the front line of treatment in their therapeutic indications. Contract manufactured products include some of the leading global biologic products which involve liquid, lyophilized and suspension presentations.

Novatek International News Updates - 1 CFR Part 11 Compliant - Out-of-the-box LIMS software solutions

August, 2010
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July, 2010

Endo Pharmaceuticals, PA, USA
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Novatek International Events Updates - 1 CFR Part 11 Compliant - Out-of-the-box LIMS software solutions
Prepare for "FDA Inspection" Review Recent Warning Letters- Aseptic Processes
June 28-29, Philadelphia, PA
Principles of "Cleaning Validation" A "How To" for a cGMP Compliant Cleaning Program
June 28-29, Philadelphia, PA
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