Novatek International has announced the latest version of its standardised environmental monitoring software EM version 2.1.
Compliance has become mission critical for many organizations.
With the proliferation of regulations, such as 21 US Code of Federal Regulations Part 11, cGMP, other international guidelines, and increased inspection from internal and external auditing agencies, all aspects of a business are impacted.
Problems associated with microbiological environmental and utility monitoring data control, documentation, reporting and trending are among those most commonly cited as objectionable during FDA inspections of manufacturing facilities.
As pharmaceutical manufacturing sites strive to reach higher levels of process maturity and compliancy, the movement towards adopting high-tech tools increases.
Therefore, an enforceable, clearly a process based complaint environmental monitoring solution is crucial, no matter your size or industry.
"EM version 2.1 is another confirmation of Novatek's consistent endeavors to look in to the future of laboratory automation and the pharmaceutical industry's need for specialized solutions," said Mike Rozbih, senior manager of technical sales and marketing, Novatek International.
Novatek International says it takes pride in providing the pharmaceutical industry with the only process based off-the-shelf, 21 CFR Part 11 compliant environmental monitoring solution.
EM enables users to track and manage all environmental and utility monitoring data for sterile and non-sterile health care industries and other industries with a requirement for environmental monitoring based on the latest guidelines from FDA, EU, ISO 14644-1 and PDA Technical report 13.
It supports CFR Part 11 and other key regulatory requirements.
EM offers complete off-the-shelf environmental and utility monitoring workflows designed by some senior members of the pharmaceutical and IT worlds such as Frank S Kohn (president, FSK Associates and a former director of Wyeth, vaccines) and Susan Cleary (associate director of product development, Novatek International).
Additional EM solution functionalities allow companies to monitor locations, personnel and utilities for viable and non-viable contamination as well as identify and track micro-organisms.
It includes an enhanced built-in statistics for rooms, personnel and utilities.
It permits location and personnel mapping, execution of investigations for incidents such as 'OOS' conditions, management of media and inventory for cost effective operations and configurable reporting and query tools for data retrieval, control and knowledge management.
