Cleanroom Monitoring Systems Keep Pharma Data Secure
Publisher: CAS DataLoggers
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Continuous and secure data acquisition and documentation is especially important in the pharmaceutical industry with its unique production & storage requirements, as well as for proprietary research and development. According to FDA CFR21 Part 11, data acquisition and cleanroom monitoring systems must operate in compliance with GAMP/GMP guidelines. For effective monitoring, measurement data and limit values for parameters such as Temperature, Humidity, Particle count and Pressure all need to be logged and archived in a format safe from manipulation. Additionally, any user intervention relevant to the processes in question must also be recorded to an audit trail. Delphin Technology’s Expert and Message series data loggers, combined with ProfiSignal analysis software, offers pharma companies a complete system performing all facets of cleanroom monitoring systems including data acquisition, monitoring, reporting & user management.
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