A successful LIMS Implementation at a Large Multi National Pharmaceutical Company
NEWSDETAILS 5th July, 2005 PDA - TRI 2005
Novatek International, a world leader in FDA compliant Laboratory Information Management Solutions, announced the successful installation and validation of its Environmental Monitoring software solution at PDA-TRI.
“The software will be used for teaching purposes, as part of several training courses at the PDA Training and Research Institute (PDA-TRI) in 2005 and beyond," said Ms. Gail H. Sherman, Vice President of Education & PDA Director.
"Our primary goal at Novatek International is to improve healthcare worldwide, by providing the pharmaceutical industry with innovative solutions and services," said Mazda Famili, Vice President of Novatek International. "An educated society is the result of combined efforts from committed instructors, receptive knowledge seekers, and encouraging learning tools and environments. We will invest heavily in our support for organizations that value and support advancement in the health care industry."
The Environmental Monitoring Software solution includes and enables companies to:
- Track and manage all environmental data for sterile and non-sterile health care industries with a requirement for environmental monitoring, based on the latest guidelines from FDA, EU, ISO 14644-1 and PDA Technical report 13
- Supports CFR Part 11 and other key regulatory requirements
- Monitor locations, personnel and utilities for viable and non-viable contamination
- Identify and track Microorganisms
- Built in statistics for rooms, personnel and utilities
- Location and personnel mapping functionality
- Perform investigation for incidents such as "OOS" conditions
- Manage media and inventory for cost-effective operations
- Configurable reporting & query tools for data retrieval and knowledge management.
About PDA
PDA is a non-profit international association comprised of more than 10,500 scientists involved in the development, manufacturing, quality control and regulation of pharmaceuticals/biopharmaceuticals and related products. The association also provides educational opportunities for government and university sectors that have a vocational interest in pharmaceutical/biopharmaceutical sciences and technology. In keeping with its fifty-year history of promoting the growth of pharmaceutical science and technology, PDA introduced its latest contribution, the PDA Training and Research Institute (PDA-TRI), in May 1997. For more information, please visit www.pda.org.
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