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FORTNIGHTLY INSIGHT FOR PHARMA PROFESSIONALS 1-15 June 2009
NOVA-EM chosen world's best selling environmental monitoring system
Novatek International's Environmental Monitoring Software, NOVA-EM, was chosen the world's best selling environmental monitoring system in 2008 for the fifth year in a row. A recent survey including 500 life science organisations worldwide - comprised of pharmaceuticals, biotech, medical devices, tissue banks, blood banks, hospitals - demonstrated Novatek International's environmental monitoring software, NOVA-EM, to be the number one choice, with a yield of more than 80 percent of votes. Speaking on the occasion, Parsa Famili, President and CEO of Novatek International stated, "We earned widespread industry support. Being the largest and setting standards for the industry, it is only logical for us to contribute to the industry. There have been hundreds of environmental monitoring user specifications that have been collected globally, from a vast array of companies in the design of our NOVA-EM software. That being the case we have created a conglomerate of the Users' Specifications representative of the process of environmental monitoring in our industry. We see the collection of universal processes' as our contribution to this industry. Whether it be from the application of the collective user specifications from daily usage or by virtue of PAT methodologies, risk assessments and operational efficiencies making our systems not only a data management tool but a 'Knowledge Management Tool'."

The company’s collective knowledge is continually conveyed by their contribution to and participation in various seminars and conferences. Novatek International will be speaking at events such as IVT, Microrite, and IPA among others."

Famili concluded by stating, "Publications are another method in which we can share with the industry our knowledge. For instance, we have contributed, to the latest PDA book by Jeanne Moldenhauer, Environmental Monitoring, Volume II Chapter 25, 'Acquisition and implementation of an Environmental Monitoring Software program'."

Susan Cleary, Director of Product Development at Novatek International added, "Novatek International's Environmental Monitoring Software, NOVA-EM is the only such system that is successfully installed and validated in six continents. Additionally, 100 percent of our clients have used Novatek's IQ/OQ validation package. The validation package has already been reviewed by regulatory authorities such as FDA, TGA, Health Canada, EMEA during routine and non-routine regulatory audits at our customer sites throughout the world." She further added that Novatek has successfully passed more than 50 client audits by companies such as Pfizer, BMS, Guidant, and Hospira, to name a few.

Dr Frank Kohn, President and CEO of FSK Associates stated that as the past Director of Manufacturing at Wyeth, Vaccines in Sanford NC, he is aware of the critical need to implement an automated environmental monitoring system in order to meet the regulatory requirements for tracking and trending environmental monitoring. Novatek's Environmental Monitoring Software, NOVA-EM brings timely and innovative automated solutions to addressing this critical industry challenge.

Advanced Quality Nova-LIMS by Novatek International.

A suite of specialized process based, modular Laboratory information managment solutions which comply with 21 CFR-Part11,cGMP,GLP,TPP,EU,Health Canada and a host of other regulations :Raw Materials Analyzer, Finished Product Analyzer, Stability Management Program, Calibration & Preventive Maintenance Data Management Solution, Environmental & Utility Monitoring Solution, Document, Audit & Training Solution, Consumable Inventory Management System, Automated Packaging Component Analyzer.

• Billing System Integration
• Custom User Interface
• Customizable Fields
• Customizable Functionality
• Customizable Physician Test Panels
• Customizable Reporting
• Data Import/Export
• Data Security
• Fax Management
• Lab Instrument Interface

• Legacy System Integration
• Mobile Access
• Multi-Currency
• Multi-Language
• Multi-Location Printing
• Online Laboratory Instrumentation
• Procedure-Based Billing
• Reporting
• Sample Tracking
• Software Development Kit

Novatek's NOVA-EM - the World's Best Selling EM Software for the 5th Year
Once again, Novatek International's Environmental Monitoring Software, NOVA-EM, was chosen the world's best selling environmental monitoring system in 2008 for the fifth year in a row. A recent survey of 500 life science organizations worldwide - comprised of Pharmaceuticals, Biotech, Medical Devices, Tissue Banks, Blood Banks, Hospitals - demonstrated Novatek International's environmental monitoring software, NOVA-EM, to be the number one choice, with a yield of more than 80% of the votes.

Upon receipt of the news, Mr. Parsa Famili, President and CEO of Novatek International stated, “We earned the widespread industry support and being the largest, and in setting the standard for the industry, it is only logical for us to contribute to the industry”.“

There have been hundreds of environmental monitoring user specifications collected - globally - from a vast array of companies, in the design of our NOVA-EM software. That being the case we have created a conglomerate of the Users' Specifications representative of the process of environmental monitoring in our Industry. We see the collection of universal process' as our contribution to this industry. Whether it be from the application of the collective user specifications from daily usage or by virtue of PAT methodologies, risk assessments and operational efficiencies making our systems not only a data management tool but a 'Knowledge Management Tool'.” “

Our collective knowledge is continually conveyed by our contribution to and participation in various seminars and conferences. Once again Novatek International will be speaking at events such as IVT, Microrite, and IPA among others.”

Mr. Famili concluded by stating, “Publications are another method in which we can share with the industry our knowledge. For instance, we have contributed, to the latest PDA book by Jeanne Moldenhauer, Environmental Monitoring, Volume II Chapter 25, 'Acquisition and implementation of an Environmental Monitoring Software program'”.

Ms. Susan Cleary, Director of Product Development at Novatek International added, “Novatek International's Environmental Monitoring Software, NOVA-EM is the only such system that is successfully installed and validated in six continents. Additionally, 100% of our clients have used Novatek's IQ/OQ validation package. The validation package has already been reviewed by regulatory authorities such as FDA, TGA, Health Canada, EMEA during routine and non-routine regulatory audits at our customer sites throughout the world”. She further added that Novatek has successfully passed more than 50 client audits by companies such as Pfizer, BMS, Guidant, and Hospira, to name a few.

Ms. Cleary will be presenting her experiences in conjunction with Mr. Mike Ansell, Manager of Microbiology, at Cangene Corporation at upcoming IVT conference, 'Developing, Deploying and Managing Best Practices for Environmental Monitoring' in San Diego Mission Bay, San Diego, CA. on Feb 25, 2009. The topic of the conference is 'Environmental Monitoring - How to Use Data and Trends for Corrective and Preventive Actions'.

In hearing the news, experts in the industry have provided their feedback:
In a one on one interview, Ms. Ziva Abraham, President of Microrite Inc. stated the Novatek International Environmental Monitoring Software, NOVA-EM is a great learning tool for all microbiologists. She further stated that she has incorporated NovaTek's environmental monitoring software as an integral part of her very popular course, 'Intensive Training in Environmental Monitoring, Disinfectant Qualification and Cleanroom Contamination Control' . Novatek's Environmental Monitoring Software, NOVA-EM helps her as a visual aid in teaching the various aspects that need to be considered when setting up an environmental monitoring program such as site selection, reporting, managing data, analyzing data to evaluate risk to product or in evaluating facility condition or personnel training. She will be also using this system as a training tool to track microbial contamination at her upcoming seminar on “Understanding The Challenges In Microbial Identification” in Foster City, CA on 19, and 20 February 2009. She went on to say that participants who have attended her EM course where she has used Novatek's software as a training tool can easily see how Environmental Monitoring Software, NOVA-EM can exponentially improve the environmental monitoring operations in their corporations.

Dr. Frank Kohn, President and CEO of FSK Associates Inc. in an interview stated that as the past Director of Manufacturing at Wyeth, Vaccines in Sanford NC, he is aware of the critical need to implement an automated environmental monitoring system in order to meet the regulatory requirements for tracking and trending environmental monitoring. Novatek's Environmental Monitoring Software, NOVA-EM brings timely and innovative automated solutions to addressing this critical industry challenge. Dr. Frank Kohn went on to state that he is assisting Novatek International in giving back to the industry by publishing a two part series article on Quality Management Program for Environmental Monitoring, a Technical Report in Novatek International's Technical News Letter Feb-Mar 2009 Edition'.

He concluded by saying Novatek International's Environmental Monitoring Software, NOVA-EM software is extensively featured in the most recent book from PDA, titled Microbiology in Pharmaceutical Manufacturing, Volume 2, by Richard Price in Chapter 16.

2006 CCM Awards Congratulations to the winners Rosemary Howie-2006 CCM Environmental Microbiology Award C. Mugabe -2006 CCM Award
The current award (2006) award is $800.00 and one year free CCM membership. The award is based on the merit of the research presented in the poster, as well as the student's ability to answer questions on his/her research project. It is expected that the project contributes significantly to the professional development of the student in microbiology. The awards are presented at the AMMI Canada - CACMID Annual Conference.

There were 36 submissions at the 2006 Student Poster Symposium held in March 2006 in Victoria.

Rosemary Howie the recipent of the 2006 CCM Environmental Microbiology Award is shown thanking CCM and Novatek International, the sponsor of the 2006 award.

The award was presented March, 2006 in Victoria at the AMMI Canada - CACMID Annual Conference.

SP.24 Modelling microbial survival in build up biofilm for complex medical devices.R. Howie, M. Alfa. Deptartment of Medical Microbiology, University of Manitoba, Winnipeg, Manitoba.

C. Mugabe, recipent of the 2006 CCM Award SP.01 Liposomal antibiotics and bacteria interactions: a mechanistic study. C. Mugabe, A Omri. Laurentian University, Sudbury, Ontario.

Novatek International's Quality LIMS software now integrates with CDS
Novatek International announces that 21 CFR part 11 compliant NOVA-LIMS software solutions now interface with most current Waters corporation Empower as well as Millennium chromatography data system (CDS).
FOR IMMEDIATE RELEASE

PRLog (Press Release) – Nov 17, 2008 – The fully integrated Nova-LIMS/Empower CDS interface provides users with the ability to transfer data directly into related Novatek LIMS modules. By default, the interface can search out and transfer any Empower/Millennium CDS field on demand, and can be completely configured to suit the needs of the client. Novatek International is known worldwide for leadership in pioneering 21 CFR Part 11 compliant pharmaceutical software solutions for the entire product life cycle of healthcare quality operations. Novatek provides solutions for manufacturing, packaging, and quality assurance and quality control. Advanced Quality Nova-LIMS applications provide a comprehensive solution that manages a product's life cycle from new product discovery and development, through to commercial production. Nova-LIMS is a 21 CFR Part 11 Compliant long-term solution that ensures you have centralized control and maintenance of all your data handling software solutions. It is comprised of specialized functional modules such as NOVA-LIMS Software system, Environmental Monitoring LIMS Software, Utility Monitoring LIMS Software, Calibration, preventive maintenance and repair LIMS software, Stability LIMS Software Application, Raw Material Analysis LIMS Software, Finished products Analysis LIMS Software, In Process Analysis LIMS Software, CAPA software, Quality System Management software, Training Management Software, Complaint Management Software, Investigation Management Software, Audit Management Software (Internal and external Audit), Document Management System and Content Management Software, Proof reading software, Packaging Component Analyzer, Lateral Flow device Reader software, Clinical Assay Management LIMS software, Validation, Content, Knowledge Management software, Batch Record, Content, Knowledge Management software, Controlled Inventory Management (LIMS, ERP, MES) system, HPLC Columns, GC Columns, Management LIMS system. NOVA-LIMS may be configured to work either as a modular unit or an integrated LIMS. Furthermore, its applications can interface with any Microsoft compatible software in order to create a complete paperless integration of data. All our solutions comply with 21 CFR part 11, Annex 11 regulations as well as ICH, Health Canada, FDA, TGA, MHRA, cGMP, GAMP 5 and a host of other policies.

# # # Novatek International provides a new breed of all-encompassing, process-driven LIMS and other software solutions that target the pharmaceutical, biotech and other health-care industries.