The Project: Modernizing Pharmaceutical Packaging Systems

Pharmaceutical manufacturers operate under strict regulatory frameworks designed to ensure safety, traceability, and production integrity. Packaging systems generate accurate batch documentation, maintain secure audit trails, and provide controlled access to production systems.

In this case, the client’s existing blister packaging line had become a bottleneck for compliance and operational reliability. The system relied on outdated PLC communications and lacked the data management capabilities required for modern pharmaceutical manufacturing automation.

E Tech Group was engaged to modernize the packaging system’s control architecture, improve operational stability, and implement infrastructure capable of supporting 21 CFR Part 11 electronic records and electronic signatures compliance.

The Challenge: Compliance Woes from Bad Batch Records

21 CFR Part 11 establishes regulatory requirements for electronic records and electronic signatures in FDA-regulated industries. Blister packaging operations must generate reliable electronic batch records, maintain tamper-proof audit trails for process changes, enforce role-based user access controls, and capture process data automatically from packaging equipment.

The company’s blister packaging system lacked compliance with 21 CFR Part 11. PLC firmware anomalies compromised stability, and the system couldn’t generate accurate batch records or maintain audit trails. User access control was also insufficient. Without these capabilities, the client was unable to demonstrate regulatory compliance during audits or maintain complete documentation for quality assurance and product release.

The Solution: Leverage Machine Vision to Bring the Receipts

E Tech Group modernized the system to meet 21 CFR Part 11 requirements. PLC communication was upgraded to Ethernet protocols for improved reliability. Integrated machine vision systems supported operational monitoring and compliance documentation. ISA-95 Level 2 integration optimized data orchestration, and Ignition SCADA was deployed for advanced logging, audit trails, alarm management, and secure access control.

A key component of the modernization effort involved upgrading the packaging line’s PLC communications infrastructure. By transitioning from legacy communication methods to industrial Ethernet protocols, the system gained faster, more reliable data exchange between controllers, sensors, and supervisory systems.

Machine vision technology was integrated into the blister packaging process to enhance both operational monitoring and compliance documentation.

In regulated environments, machine vision provides critical evidence for compliance by documenting inspection results and linking them directly to batch records. This capability helps manufacturers maintain detailed production documentation while improving overall quality control.

The Results: Full Compliance, Traceability, & Reliability

The upgrade achieved full regulatory compliance, enhancing audit readiness and data integrity. PLC anomalies were resolved, ensuring stable operations. Comprehensive batch reporting supported QA and throughput analysis. Robust audit and alarm logging improved traceability, and strict user access controls fortified system security.

By implementing secure electronic recordkeeping and automated audit trail generation, the new packaging system significantly improved the client’s readiness for regulatory inspections. Digital records can now be retrieved quickly and reliably, allowing quality teams to demonstrate compliance with FDA requirements without relying on manual documentation processes.

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