The compliance and data intelligence layer for regulated pharma.
Built for global life sciences manufacturers, Pharma Intelligence 4.0 automates GxP compliance, replaces paper validation and unifies batch, deviation and audit data into a single real-time record.
- 99.99%
- Audit integrity
- −72%
- Validation cycle
- 24/7
- GxP monitoring
Aligned with the most demanding pharmaceutical standards.
Every record, signature and workflow is mapped to the underlying regulatory clause and auditable on demand across jurisdictions.
21 CFR Part 11
United States · Electronic Records & Signatures
- Trustworthy, reliable, and equivalent to paper records
- Secure, computer-generated, time-stamped audit trails
- Binding electronic signatures with unique user attribution
RDC 658/2022
Brazil · Good Manufacturing Practices
- Computerized system validation (Annex IV)
- End-to-end ALCOA+ data integrity
- Batch traceability and parametric release
Annex 11
European Union · Computerized Systems
- Risk-based validation across the GxP lifecycle
- Controlled supplier and service-provider agreements
- Periodic review with documented change control
One console for every regulated process.
From the manufacturing floor to QA release — recorded, signed and chained in real time.
| UTC | Actor | Action | Event | Hash |
|---|
- URS captureddone
- Risk assessment · GAMP 5done
- IQ / OQ executeddone
- PQ in progressactive
- QA e-signaturepending
- Periodic reviewpending
Live metrics computed from the connected backend · demonstration dataset.
Engineered on the primitives regulated pharma requires.
A production-grade platform for regulated operations at industrial scale.
Real-time data intelligence
Designed to stream PLC, MES, and LIMS telemetry into a unified GxP layer with low-latency processing.
Tamper-evident audit trails
Append-only records, cryptographic hashing and isolated key management — engineered to detect any change.
Paperless validation
URS → PQ in one workflow, with automated traceability matrices and electronic signatures.
Predictive QA
Anomaly-detection models designed to surface deviations before they impact release specifications.
Multi-site, multi-region
One platform architected for US, EU, and LATAM regulatory jurisdictions.
Inspection-ready by design
Generate a complete, signed evidence dossier for audits directly from the platform.
A four-layer stack between your plant floor and the regulator.
Plant Floor Connectors
OPC-UA · MES · LIMS · SCADA · IoT
GxP Data Fabric
Streaming · Normalization · ALCOA+ enforcement
Compliance Engine
21 CFR Part 11 · ANVISA RDC 658 · EMA Annex 11
Intelligence Layer
Predictive QA · Release scoring · Inspection AI
Bring Pharma Intelligence 4.0 into your operation.
A confidential, director-level review of your compliance posture, data maturity and automation potential — delivered by our pharmaceutical engineering team within 10 business days.
Designed for global life sciences manufacturers