Data Integrity Lifecycle
Process
→ Raw Material & Component Management
→ Weighing, Dispensing & Staging
→ Media & Buffer Preparation
→ Equipment Preparation & Cleaning
→ Upstream Processing
→ Downstream Processing
→ Formulation & Compounding
→ Filtration, Sterile Processing & Aseptic Transfers
→ Filling & Finishing
→ Packaging & Labeling
→ Environmental & Utility Systems
→ Deviation, Change & GMP Quality Systems
→ Batch Review, Disposition & Product Release
→ Technology, Automation & Digital GMP Layers
Equipment
→ Weighing & Dispensing Systems
→ Bioreactors, Reactors & Fermentation Systems
→ Mixing, Compounding & Hold Vessels
→ Chromatography, UF/DF & Filtration Skids
→ Cleaning & Sterilization Systems (CIP / SIP / Autoclaves)
→ Centrifugation Systems
→ Aseptic Filling Lines, Isolators & RABS
→ Lyophilization Systems
→ Environmental Monitoring & Cleanroom Control Systems
→ Utility Monitoring Systems (PW, WFI, Clean Steam, Compressed Air)
→ PLC-, SCADA- & BMS-Controlled GMP Equipment