- Raw Material/Product Specifications
- Supplier Management and Qualification
- FDA 21 CFR part 11 Compliance
- Quality Control (QC)
- Quality Assurance (QA) as per cGMP norms
- Sampling Plan, Stability Testing
- Batch Monitoring Activities by Inspection Plan
- Electronic Execution of SOP’s by Inspection Checklist
- Electronic Batch Ticket and Electronic Weigh Sheet.
- Non-conformance (NC)
- Corrective and Preventive Action (CAPA)
- Easy Material Substitutions
- Multiple Packaging of Same Formulation
- Manufacturing Batch Record (MBR)
- Shelf Life/Expiration Support
- Bi-directional Lot Traceability and Lot Recall
- Separate Granular Costing of Formula and Packaging Material
- Supports Contract Manufacturing
- Adverse Event / Complaint Reporting
- Maternity Management
- Allergen Management
- Master Production Scheduling (MPS)
- Material Requirement Planning (MRP)