Environmental Monitoring Program is an application capable of capturing 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.
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