GXP Control System Validation

Control system validation is a critical process in the pharmaceutical and chemical industries, essential for safeguarding data integrity, verifying the functionality of automated systems, and ensuring compliance with international regulations.

 At IDI, we validate automation, control, and supervisory systems with a full-service, structured approach based on risk analysis. Our mission is to guarantee that each system performs its intended function safely, reliably and in full compliance with applicable regulatory standards.

 Scope of our services

• Validation of SCADA, PLC, and DCS systems used in critical production processes.

• Review and validation of industrial software (CSV) according to GAMP 5 guidelines.

• Compliance with FDA 21 CFR Part 11, EU GMP Annex 11, and ISO 13485 regulations.

What does our service include?

• Regulatory Impact Analysis.

• GAMP Classification.

• URS - User Requirements Specifications.

• Functional Specifications.

• SAT - Site Acceptance Test.

• IQ, OQ and PQ specific to Control System.

• FAT - Factory Acceptance Test.

• VMP - Validation Master Plan.

• QR - Qualification Report.

• Periodic Reviews.

• Decommissioning.