PLC System (Programmable Logic Controller) – Qualification Execution Checklist

Qualification Execution Checklist for PLC System

Equipment Details

Equipment: PLC System (Programmable Logic Controller)

Subcategory: Computerized Systems (Manufacturing Automation)

Area: Production

DQ/IQ/OQ/PQ: Yes/Yes/Yes/Yes

CSV Required: Yes

Pre-start

Training completed
Standard Operating Procedures (SOPs) reviewed
User Requirements Specification (URS) approved
Risk Assessment (RA) approved

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) status verified

Protocol Readiness and Approvals

Protocols prepared and reviewed
Approvals obtained from all relevant stakeholders

Execution Controls

Good Documentation Practices (GDP) followed
Data recording procedures in place
Deviations managed and documented

Review and Approvals

Engineering review completed
Validation review completed
Quality Assurance (QA) review completed

See also Implant Cutting Machine – DQ Protocol