The Tetra Tech Digital Systems Group delivered a SCADA data platform that eliminated data gaps, enabled real-time monitoring, and supported U.S. Food and Drug Administration (FDA)-compliant reporting.
A leading pharmaceutical manufacturer operating across 55 controlled rooms in Dallas, Texas, required improved data reliability from its Nano variable particle (NVP) devices to meet FDA 21 CFR Part 11 requirements. The existing system did not maintain sufficient data resolution to support compliant batch reporting. We assessed the data architecture and identified gaps in air particle measurements occurring at multi-minute intervals. Historical data limits delayed access to current conditions and rotated prior records, preventing accurate, up-to-date reporting.
During remediation, we identified metadata and scripting errors that disrupted device control and data collection. Limited real-time visibility prevented implementation of an effective alarm system, so chemists relied on manual review of daily data to identify noncompliant conditions, document findings, and complete required batch reporting.
Tetra Tech assessed the data architecture, identified root causes of data loss, and delivered a corrected and fully integrated SCADA solution within an accelerated timeline. We upgraded the SQL database, reset indexing structures, and eliminated transaction constraints that limited data capture. The updated system now records particle measurements at one-minute intervals, ensuring continuous and reliable data availability during production processes.
We also corrected metadata and scripting errors, restoring accurate device control and data collection, by designing and deploying a closed-loop control system integrated with the Ignition SCADA platform, enabling automated monitoring, control of NVP devices, and centralized data management. To strengthen operational response, we configured a real-time alarm system that notifies chemists of air particle conditions as they occur. This capability enables immediate corrective action and supports continuous compliance with FDA requirements. We continue to support and enhance the system, ensuring sustained performance and ongoing improvement.
Benefits
- Enabled FDA-compliant batch reporting with accurate data
- Eliminated data gaps with one-minute resolution measurements
- Reduced manual data review through real-time monitoring
- Improved response time with automated alarm notifications
- Increased operational efficiency and reduced downtime
The Tetra Tech Digital Systems Group provided a real-time SCADA platform, enabling continuous FDA compliance.