From tech transfer to batch release, OPTIVIA turns plant and quality data into guided actions – predicting deviations, lifting yield, and delivering audit-ready evidence with human-in-the-loop control.
GxP standards built-in for Pharma environments.
Each pillar deploys independently and connects via APIs. Use what you need today; combine the next as you grow.
Risk scoring
Transfer packs
PPQ to Commercial
CPP/CQA mapping
Equipment/method fit
Ingest sponsor documents, map CPP/CQAs, check method/equipment fit, score risks, and generate a blueprint MBR – so PPQ moves faster with fewer gaps.
Drift alerts
Prescriptive fixes
Right-first time
Fewer holds
Schedule stability
Stream live signals from SCADA/DCS/PI, detect golden-batch drift, and surface prescriptive fixes to prevent holds and stabilize schedules.
Yield lift
Causality
Simulation
Within specs
Material/lot insight
Identify true yield drivers with causality, then simulate compliant parameter changes to unlock uplift without breaking specs.
Release by exception
Evidence packs
Traceability
CAPA intelligence
Audit-ready
Centralize compliance, simulate audits, learn from CAPA patterns, and keep every action traceable for release-by-exception.
Evidence auto-collation
E-sign
FDA/EU-ready
Role-based approvals
Immutable log
Auto-collate cross-system data, verify specs, assemble FDA/EU-ready packs, and route for e-sign – humans approve, system proves.
Data → Intelligence → Guardrails.
Connect securely to MES/LIMS/QMS/ ERP/CMMS/SCADA/DCS/PI; mask PII/PHI; enforce roles.
Golden-batch models, drift detection, causality, simulation; human-in-the-loop for sensitive steps.
Guardrails enforce e-signatures, check AI inputs/outputs, record immutable logs, and keep decisions explainable.
Choose the entry point that fits your roadmap.
Begin with one pillar (common starts: Tech Transfer or Batch Release).
Pair Production Monitoring + Yield Optimization for stability and uplift
Add Quality & Risk once you establish evidence packs and traceability.
What teams achieve with OPTIVIA.
faster tech transfer
fewer deviations
yield uplift
not weeks to release
* Teams typically hit these targets when core digital systems (MES/LIMS/QMS/ERP) exist; otherwise, staged digitization helps approach them.
Start with one pillar and add others over time—OPTIVIA is modular.
AI prepares; humans approve with role-based e-sign and full traceability.
You can achieve it where digital systems already exist; otherwise we start with staged digitization.
No. OPTIVIA plugs into your existing stack via APIs/files. Start with one pillar and expand.
We include a CSV starter pack and keep e-signatures and immutable logs by default.
