Programmable Logic Controllers (PLC) and Human Machine Interfaces (HMI) control critical equipment, utilities, and automated processes in pharmaceutical manufacturing. Ensuring these systems are validated is essential for maintaining process reliability, data integrity, and full GMP compliance. PrimeGMP provides complete lifecycle validation of PLC/HMI systems, including hardware, software, alarm logic, and recipe controls.

1. System Assessment & GAMP Categorization

• Categorization of PLC/HMI system as GAMP 5 Category 4/5
• Review of system architecture, I/O lists, PLC panels, and wiring
• Identification of critical process control loops and interlocks
• Data integrity risk assessment (ALCOA+)
• Assessment of control strategy, SCADA connectivity & historian modules

2. Validation Planning & Documentation

We prepare full validation documentation including:

• Validation Plan (VP)
• URS – User Requirement Specification
• FRS/FS – Functional Requirement Specification
• SDS/DS – Software & Hardware Design Specification
• Risk Assessment / FMEA
• Traceability Matrix (TM)
• Vendor Assessment (if applicable)
• Change Control Planning

3. Installation Qualification (IQ)

• Verification of PLC/HMI hardware installation
• Review of panel wiring, I/O terminal identification, and cable schedules
• Verification of PLC modules, relays, power supply, communication ports
• SCADA/HMI software installation checks
• Review of OEM documents, license keys, and version control
• Backup & restore testing
• Verification of environmental & network setup

4. Operational Qualification (OQ)

PLC Functional Testing

• I/O testing for all digital & analog signals
• Interlock and safety logic verification
• Verification of alarm logic and permissives
• Emergency stop (E-Stop) functionality tests
• Sequence logic testing (start-up, shutdown, fault recovery)
• Manual/Auto mode verification

HMI / SCADA Testing

• Display & navigation verification
• Access control & user role-based security testing
• Alarm display, acknowledgement, and historical logs
• Real-time trends, reports, and data retention
• Audit trail verification (if integrated with Part 11 systems)
• Verification of recipe management and setpoint control

5. Performance Qualification (PQ)

• End-to-end system performance under actual operating conditions
• Process simulation and batch execution (where applicable)
• Verification of real-time control accuracy
• Recipe execution and parameter control testing
• Verification of alarm response during dynamic operation
• System response during power failure & recovery
• Testing of communication between PLC–SCADA–HMI–Historians

6. Data Integrity & Part 11 / Annex 11 Compliance

• Audit trail testing (creation, modification, deletion events)
• User access control and electronic signatures
• Password policies & session timeout verification
• Data backup, archival & retrieval testing
• Verification of secure communication & time synchronization
• Review of data storage integrity and redundancy

7. Documentation Provided

• URS, FS/FRS, DS/SDS
• Risk Assessment (FMEA)
• IQ / OQ / PQ Protocols & Reports
• I/O Testing Sheets
• Alarm & interlock test reports
• Audit trail verification records
• Access control test sheets
• Backup/restore validation records
• Change control & configuration management documents
• Final Validation Summary Report

Systems Covered

• PLC Panels (Siemens, Allen-Bradley, Mitsubishi, Delta, Schneider, Omron, etc.)
• SCADA Platforms (WinCC, Wonderware, Intouch, iFix, FactoryTalk)
• HMI Panels (Siemens, AB PanelView, Delta, Proface, etc.)
• Process Equipment Panels (Autoclave, RMG, FBD, HVAC AHU panels)
• Utility Systems (Water System, Nitrogen, PSG, Compressed Air)
• Packaging Lines & Automated Material Handling

Why Choose PrimeGMP for PLC / HMI Validation?

• Deep understanding of automated pharma equipment
• Expertise in safety logic, control loops & sequence controls
• Strong command over GAMP 5 & Part 11 requirements
• Accurate I/O verification using calibrated test instruments
• Audit-ready documentation & clear traceability
• Ability to troubleshoot logic, interlocks, and SCADA integration