IT Commissioning, Qualification & Validation (CQV) for:
- DCS Batch S88 & S95
- PLC Skid WFI CS RODI CIP
- CSV Computer Systems Validation
- MES EBR BatchReport by Exception
- SQL Transaction Event Database
- PI Enterprise Historian Time-Series
- IT SOFTWARE Configuration Mgmt.
- Automated Cleaning CIP & SIP
- UTILITIES Clean WFI Hot & Ambient
- UTILITIES BAS, HVAC, Chilled Water, Condensing Water & Steam
- AUTOMATION Purification, Fractionation, UF/DF, Filtration & Buffer Prep
- FILL FINISH Isolator & Inspection / Verification
- PROCESS SUPPORT Autoclave, Glass Washers, IBC lifts, Filter Clean skids
- EMS Environmental & Chamber Monitoring
- FS & DDS and related Validation Protocols for IQ / OQ
- FAT & SAT including Vendor Deliverable Requirements
- IT SYSTEM Network Architecture & Sequence of Operations
- VERIFICATION & WALK DOWN P&ID, Process, Controls, Fieldbus checkout
- 21 CFR Part 11 Data Integrity & Audit Trail
- ICH Q7 Q9 & Q10 Guidelines & ASTM E2500
- GAMP 5 & cGMP Practices
- MES Recipe Authoring
- Workflows & Electronic Work Instructions
- WIP Work-In-Progress & Intermediates
- Equipment Tracking Container & Status
- Material Management Track Weigh & Dispense
- Alarm Notification