Lims extension environmental monitoring program is capable of capturing, managing, and reporting all environmental data in a 21 CFR Part 11 compliant, fully validated system
Novatek announces the release of its latest addition to the Nova-Lims product family.
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 modules include raw materials analyser, finished product analyser, stability program, calibration and preventive maintenance, and now environmental monitoring program. Environmental monitoring program is an application capable of capturing, managing, and reporting 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 investigation window allows the user to investigate out of specification (OOS) with capability to add any files such as picture, audio video, scanned documents etc, to the report.
The combined utility/environmental monitoring functionality provided in this software is used to capture and transform raw data into valuable information making the environmental monitoring program a powerful tool.
