A commercial drug manufacturer in collaboration with E Tech Group implemented a critical monitoring system that required environmental data to be recorded in a 21 CFR Part 11 compliant manner. What Was at Stake: The Role of Critical Control Data in This Facility In this facility, critical control data played a central role in maintaining uptime, coordinating production, and ensuring regulatory compliance. This included: Losing access to this data — even temporarily — could have disrupted operations, reduced batch quality, or triggered costly downtime. The Plan to Mitigate Risk With an intent to mitigate the risk of data loss, the drug manufacturer chose Vaisala instrumentation to read and locally store environmental data. The Vaisala instrumentation chosen can store environmental data locally on the device and report environmental data to an OPC-compliant SCADA system. The drug manufacturer had a need for a solution that moves data stored on the devices to the Rockwell Automation SCADA system in the event of data loss. E Tech Group provided a solution that detects data loss, recovers the lost data from the devices, and moves it to the SCADA system. The solution included a Windows service that polls the SCADA for gaps in historian data. If a gap is found, the solution pulls data from the buffers and populates it into the SCADA system. This provides redundancy and verification that critical data resides in a single repository, ensuring data integrity. The customer relied solely on the existing SCADA and used the most robust instrumentation to protect against critical data loss. The Need for a Professional System Integrator The end-user chose Vaisala instrumentation equipped with loggers that provide data buffering to protect against critical data loss. However, the buffering capability did not integrate “off the shelf” with the existing SCADA, Rockwell Automation FactoryTalk. The buffered data from … Continued