Our services include integrating automated systems with various pharmaceutical and biotech processes. MKCS, Inc. is immersed in all aspects of the Validation Process for automated systems in FDA regulated industries.

Our experience with various DCS, PLC, and SCADA platforms that are familiar to the healthcare industry means that MKCS is also capable of developing Requirement and Design specifications.

Programming

• Distributed Control Systems (DCS)
• Supervisory Control And Data Acquisition (SCADA)
• Programmable Logic Controllers (PLC)
• Process Data Historian
• Graphical User Interface
• Human Machine Interface
• Batch Processing
• Continuous Control
• Interlocks

System Design & Documentation

• User Requirements
• Design and Functional Specifications
• User Documentation

Project Management

• Cost Estimating
• Scheduling
• Progress Monitoring
• Multi-Discipline Management

Validation

• Commissioning
• Installation Qualification - IQ Protocol Generation and Execution
• Operational Qualification - OQ Protocol Generation and Execution
• Change Control

Hardware/Software Testing

• Factory Acceptance Testing (FAT)
• Site Acceptance Testing (SAT)
• Engineering/Development Tests

Production Support

• Software Maintenance
• Service Calls
• Process Optimization
• Throughput and Capacity Analysis
• Cost/Risk/Benefit Analysis
• Training