Every Movement. Accounted For.
SICORG helps pharmaceutical manufacturers run production, quality, inventory, finance, and compliance in one AI-native ERP.
01PLATFORM
Built for GMP, Schedule M & 21 CFR Part 11 Compliance
Connect production, quality, warehouse, and compliance teams. Execute batch manufacturing records with full electronic signatures and audit trails.
01. Production & Batch
BOM, Master Recipes (BOP), BMR/EBR, Batch Traceability, Genealogy, Yield & Reconciliation
02. QA / QC Intelligence
CoA Generation, OOS, OOT, Stability Testing & QC Pending Hold
03. Deviation / CAPA
Deviations, CAPA, Change Control & Automated Investigation Workflows
04. Data Integrity & Part 11
Audit Trails, E-Signatures, User Activity & Override Reports
05. Materials & Warehouse
Raw Materials, Packing Materials, FEFO Enforcement & Expiry Alerts
06. Multi-Plant Consolidation
Unified multi-facility management, inventory transfers & intercompany balance tracking
07. Audit & Regulatory
Internal Audit, External Audit, Inspection Readiness & Compliance Tracker
08. AI Compliance Engine
Risk Scoring, AI Alerts, Trend Detection & Executive Management Summaries
See a live product demo of SICORG AI-Native ERP
See why leading formulation, API, and biopharma manufacturers rely on SICORG, the AI-native ERP for pharmaceutical operations.
Offload the busy work. Keep the compliance.
Not a generic chatbot. Specialized AI agents embedded in your pharmaceutical manufacturing workflows, trained on GMP guidelines, SOPs, and 21 CFR Part 11 requirements.
Query your pharmaceutical operations
Ask questions in plain English about batch execution status, QC analytical results, or inventory lot tracking. SICORG applies GMP and Part 11 logic first to surface verified answers.
AI-assisted, human-approved workflows
Draft deviations, CAPA records, and QC holds with AI assistance — reviewed and approved by your team before anything is final. Every step logged, every signature yours.
Always on, always working
Context-aware intelligence across batch genealogy, electronic batch records (EBR), and material movements. SICORG continuously flags FEFO violations, OOS trends, and yield anomalies before final QA release.
Unified enterprise connectivity
Connect SICORG to LIMS, MES, SAP, QMS, and external lab instruments through our secure Model Context Protocol (MCP) and API layers, maintaining a single, unbroken audit trail.
Connect your existing systems to SICORG
Connect operational data across your existing systems without losing visibility, consistency, or traceability.
0421 CFR PART 11 COMPLIANT
21 CFR Part 11 Audit Trails & E-Signatures
Maintain 100% ALCOA+ data integrity across every batch record, deviation, CAPA, and warehouse movement. Immutable electronic signature logs keep your plant inspection-ready for US FDA, WHO, and EU GMP audits.
Make every batch and movement accountable.
Faster batch release, 100% data integrity, automated audit readiness.