-93%
Record Compilation Time
0 in 2 audits
Regulatory Findings
Real-time
In-run Deviation Detection
14
Vessels Monitored
The Challenge
Batch manufacturing at the plant required paper batch records that QC staff compiled manually after each run — a process taking an average of 45 minutes per batch. During a regulatory audit, inspectors identified two batches where the paper records had gaps in parameter sign-offs. Retrieving historical batch documentation for a customer query required locating physical folders from the archive room, sometimes taking hours.
The Solution
Deployed Electronic Batch Records and SPC Process Control on MACHHUB. Fourteen reaction vessels and mixing tanks were connected via OPC-UA, with process parameters — temperature, pressure, pH, agitator speed, and flow rates — captured automatically throughout each run. Batch records auto-populate with live process data; supervisors perform a three-minute digital review and e-sign to release. SPC control charts flag out-of-trend parameters in real time.
The Result
Batch record compilation time dropped from 45 minutes to a three-minute supervisor review. Two consecutive regulatory audits returned zero findings related to batch records or data completeness. Out-of-spec process parameter detection improved significantly — process deviations are now caught during the run rather than during post-batch review.
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