1. RESPA for Life Science
Requirement Estimation Scheduling Production & Accounting
Life Science Enterprise Solution Requirements
Materials Management,
• FIFO issues for Raw & Packing Material
• Manufacturing & Expiry Period tracking for Material
• Potency Calculations for active ingredient during Material Issue
• Batch Tracking for Raw Material
• Material Retest Period
• Material Accounting for Contract Manufacturer, to Contract Manufacturer
• MRP Calculations, Location wise (Contract Manufacturing) & compilation
Quality Assurance
• Requirements of cGMP documentation • Quality Specification Version Control
• Retain/ Control Sample Register • Sampling Plan for Materials
• ISO9000/ 21 CFR Part 11 documentation • Customer Complaints
• Instrument Calibration Records • Third Party Test Lab Follow
• Stability Scheduling
Production Management
• Planning with contract manufacturers • Monthly/ Weekly/ Daily/ Shift wise plan
• Inventory Projections • Production Statistics product & stage wise
• Contract Manufacturing Details • Stability Scheduling
Maintenance Management
• Maintenance Planning • Corrective Maintenance
• cGMP documentation about Maintenance • Statutory Documentation
• Spare Parts Management
Distribution Planning & Management
• Distribution / Logistic management • Distribution network
• Dispatch Planning • Transportation Planning
• Link to Own & Contract Manufacturing Data • Batch Tracking for finished product
• Batches Due for expiry
Security & Audit Trail as per 21 CFR Parts 11 Requirements
©RESPA Inc. 2009