21 CFR Part 11 & Security Governance
Every entry, every edit, every approval logged with user ID, timestamp, and mandatory justification for complete ALCOA+ data integrity.
21 CFR Part 11 & EU Annex 11
Designed to meet US FDA and European regulatory requirements out of the box.
100% Attributable Audit Trail
Track timestamp, user ID, previous value, new value, and mandatory reason for change.
Data Fiduciary Standards
Secure architecture adhering to global data protection and privacy regulations.
Built to handle the messy reality of pharma operations
Batch records, sensor telemetry, quality interlocks, and compliance infrastructure built for modern life science plants.
Enterprise-grade security & immutable audit logs
Encryption at every layer, continuous monitoring, and independent validation—the exact standard your inspectors, quality teams, and auditors expect.
- Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA+) data records
- Full history playback for batch manufacturing, warehouse FEFO, and QC test records
- System-enforced justification capture for data overrides and master record changes
Role-based access & Segregation of Duties (SoD)
Strict permission controls ensure makers cannot self-approve batch releases or Goods Receipt Notes (GRN). Custom roles for QA, QC, Store, Production, and Auditors.
- Fine-grained role assignment by plant location, department, and operational object
- Enforces dual-person verification for critical production and release steps
- Prevents unauthorized master recipe or specification edits
Approval workflows & electronic sign-offs
Configurable approval tiers for Purchase Orders, BMR batch releases, Certificate of Analysis (COA) authorizations, and deviation closures.
- 21 CFR Part 11 compliant dual-credential electronic signatures
- Automatic quarantine locks on pending test items until QA sign-off
- Instant notifications and approval tracking across departments
View-only access for external regulatory auditors
Provide safe, read-only portals for US FDA, WHO, and EU GMP inspectors without exposing edit rights or risking record alterations.
- Instant inspection-ready package exports in minutes
- Prevent accidental modification or deletion of historical BMR/EBR logs
- Full transparency into system event logs and override histories
Explore more SICORG features
Everything built natively into one AI-native pharmaceutical operating system.
Make every pharma operation more connected
One AI-native ERP for production, quality, inventory, finance, and compliance.