Orange County, California, USA, Feb 12th 2009,
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.
For more information on acquiring “The
Standard” in Environmental Monitoring contact your local
representative at www.ntint.com and
see for yourself why Novatek’s Environmental Monitoring Software is
the primary choice of hundreds of clients, including such multi
nationals as Pfizer, Novartis, BMS, DSM, Lifenet, Abbott Vascular,
LifeCore, Delta Pharma, Celtrion, Lonza, Cangene, Hollister Stier (Jubilent)
among many others in the four corners of the world.