Automation Engineering Services

At CellSpark Consulting Inc., we provide Automation services tailored for our industry partners. Our focus is on ensuring seamless integration, system reliability, and compliance across all stages of automation, from design through validation.

Automation Project Design & Integration

  • Development of User Requirements Specifications (URS) for automated systems
  • Functional Design Specification (FDS) and Control System Architecture Design
  • PLC, SCADA, HMI, BMS, EMS, and DCS integration planning (e.g., DeltaV, Siemens, Allen-Bradley)
  • Instrumentation specification and I/O mapping
  • Equipment and facility interface strategies

Programming & Configuration

  • PLC logic development and ladder programming
  • HMI/SCADA visualization design
  • Batch configuration using S88/S95 standards
  • Alarm management strategy and implementation
  • Network architecture and cybersecurity considerations (GAMP 5 aligned)

Commissioning & Qualification Support

  • Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT)
  • IOQ and PQ protocols for automated equipment and systems
  • Software Verification and 21 CFR Part 11 compliance checks
  • Data integrity and audit trail testing for automated records
  • Support during inspection-readiness and tech transfer activities

Lifecycle & Change Management

  • Change control documentation for software revisions and requalification
  • Backup/restore procedures and disaster recovery planning
  • Legacy system upgrades and migration planning
  • Automation lifecycle strategy aligned with GAMP 5 and ASTM E2500

Digitalization & Smart Manufacturing

  • MES integration and electronic batch record (eBR) configuration
  • Real-time data acquisition and historian systems (e.g., OSIsoft PI, AVEVA)
  • Digital twins and simulation models for process optimization
  • Support for Pharma 4.0 initiatives: predictive maintenance, AI/ML use cases

Compliance & Validation Documentation

  • Automation Qualification Summary Reports
  • Traceability Matrix linking URS to testing
  • GxP documentation aligned with CSV principles
  • Review of vendor-supplied documentation (software BOMs, protocols)

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