Inspection-ready every day, not just before the audit
Equip internal compliance teams and external regulatory inspectors with secure, read-only access to complete chronological batch histories, electronic signature trails, and verified change logs.
Strict ALCOA+ data integrity enforcement
Ensure all records are Attributable, Legible, Contemporaneous, Original, and Accurate across every manufacturing and quality transaction.
Immutable, chronological audit logs
Every record creation, edit, override, and deletion captures the previous value, new value, user ID, timestamp, and mandatory justification at the moment of action.
Comprehensive audit package exports in minutes
Compile full batch dossiers, change histories, and linked CAPAs into a single verifiable export package instead of manually gathering papers across departments.
Built to handle the messy reality of pharma operations
Batch records, sensor telemetry, quality interlocks, and compliance infrastructure built for modern life science plants.
Complete history playback for every batch and record
Inspectors demand to see the exact sequence of events during manufacturing and testing. SICORG maintains an append-only, server-side timestamped log of every modification, ensuring absolute transparency and trust during regulatory audits.
- Old value, new value, user ID, and timestamp captured for every quality edit
- Electronic signatures bound directly to authorized actions rather than generic logins
- Secure, read-only inspector portals preventing accidental record alteration
Structural segregation of duties (SoD)
The system enforces strict permission boundaries—a batch record creator cannot approve its own QA release. Segregation of duties is hardcoded into the workflow architecture, removing reliance on manual enforcement policies.
- Multi-tier approval gating for batch release, deviations, and CAPA closures
- System-blocked self-authorization on all critical GxP steps
- Complete user activity history available instantly alongside batch files
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.