Industry: Medical & Pharmaceutical
GMP-Ready Automation for Medical Device and Pharmaceutical Production
Automation in regulated environments requires more than engineering skill — it requires documentation discipline, validation planning, and an understanding of how regulators audit systems. FERSMEK delivers automation built for the audit, not just the production floor.
Discuss Your Validation RequirementsWhat We Deliver
- IQ/OQ/PQ validation documentation for all automated systems
- 21 CFR Part 11 compliant HMI and data logging where required
- Cleanroom-compatible materials and sealed enclosures (IP65+)
- Full user access control with audit trail logging
- Vision systems for fill level, cap presence, label inspection
- Serialization and 2D barcode integration for track-and-trace
- Change control documentation and re-validation support
- Preventive maintenance programs aligned with GMP schedules
Validation Approach
URS
User Requirements Specification aligned with regulatory intent
FS/DS
Functional and Design Specification reviewed before fabrication
IQ
Installation Qualification — system installed per approved drawings
OQ
Operational Qualification — system performs to specification across defined ranges
PQ
Performance Qualification — system meets production requirements consistently
Automation That Passes the Audit
Our engineers understand validation requirements before the first line of code is written. Let's discuss your regulatory environment and build the right documentation plan.