Securing Automated Manufacturing Operations
From bioreactors to capsule printers to mixers, automated equipment requires failsafe validation to avoid disruptions. Our team have optimized over 500 process control platforms, including:
- Programmable Logic Controllers (PLCs)
- Supervisory Control and Data Acquisition (SCADA)
- Human Machine Interfaces (HMIs)
- Distributed Control Systems (DCS)
- Building Management Systems (BMS)
- Industrial Data Loggers
- Machine Vision Camera Systems
Through functional testing and risk analysis following GAMP 5 methodology, our protocols thoroughly validate:
- Logic programming meets specifications
- Failsafe/redundancy functions activate
- Recovery/backup protocols perform
- Data flows and calculations are accurate
- Parameter edit authorizations function
- Audit trail records all changes
- Calibration safeguards maintain tolerances
“Valitech’s validation of our bioreactor controls has enabled smooth agency inspections and accelerated new product ramp-up by over 35%.”
Director Manufacturing Services, Cellugen
Our validation deliverables include:
- User Requirements
- Functional & Design Specs
- Traceability Matrix
- Installation, Operation & Performance Qualification
- Risk Analysis & Mitigation Strategies
- Periodic Review Plan
With turnkey validation documentation ready for client signature, feel empowered to scale production confidently while staying inspection-ready.