System Validated

Total Control of your Plant, without Paper Chaos.

The Operating System for GxP Manufacturing

Standard in the Pharma Industry

GxP RECORDBatch: #BATCH-2025-X
Validated Record (GxP)
SENSOR: VIBR-01
LIVE

Amplitude

0.04 mm/s

Frequency

120 Hz

ESTÁNDARES Y CUMPLIMIENTO NORMATIVO

FDA 21 CFR Part 11 Ready
EU GMP
ISO 9001
ALCOA+ Data Integrity

Designed and validated under these standards. Validation documentation available upon request.

Built for Regulated Industries

NexIndu adapts to the compliance requirements of each sector, out of the box.

Pharmaceutical

FDA 21 CFR Part 11 · GMP · ANMAT

Food & Beverage

ISO 22000 · HACCP · SENASA

Medical Devices

ISO 13485 · FDA QSR · CE Mark

Chemical & Industrial

REACH · ISO 9001 · OHSAS

Up and Running in Days, Not Months

No complex infrastructure. No lengthy implementations. NexIndu is designed for fast, validated deployment.

01

Configure Your Assets

Load your equipment hierarchy, assign responsible teams and upload your SOPs and technical manuals.

02

Train Your Team

Built-in Academy module with GxP courses and exam registry. Your team is audit-ready from day one.

03

Operate with Full Compliance

Every action is logged, signed and immutable. Real-time dashboards give you 360° visibility across your entire plant.

8 Integrated Modules

Everything You Need. Nothing You Don't.

Eight integrated modules that cover the complete operational lifecycle of your plant.

Work Orders

Full lifecycle management with shift discrimination and granular MTTR tracking.

Preventive Maintenance

High-density template builder with dynamic scaling and Mirror Mode preview.

Asset Control

Parent-child hierarchy with unified logbook mixing work orders and operational notices.

Analytics & Pareto

Interactive drill-down dashboards with downtime indicators and Nexi AI summaries.

Nexi AI Copilot

RAG-powered assistant that cross-references your SOPs to support every critical decision.

Academy

GxP e-learning with multiple choice exams and full audit trail for training compliance.

Immutable Audit Logs

Every action is permanently recorded at DB level. REVOKE UPDATE/DELETE enforced.

Offline-First PWA

Cloud sync every 5s, local sync every 500ms. Production never stops for connectivity.

"Critical Alert: Deviation in Batch #402. Temperature exceeded 190°C. I suggest preventive quarantine and valve V-203 review per SOP-99."

Nexi AI
Decision Support (AI)

Meet Nexi

Your industrial copilot that eliminates human error. Nexi instantly accesses your SOPs and solution history to assist your technicians in every critical decision.

  • Man-Hour Optimization (-40%)
  • Zero Deviations due to Log Errors
  • Strategic Real-Time Visibility

The Cost of Human Error vs. Digital Certainty

Mitigate operational and regulatory risks. NexIndu transforms your plant into an immutable compliance fortress, eliminating paper and ensuring data integrity (ALCOA+).

RISK

Paper Management (The Past)

  • Loss of Traceability
  • Disconnected Data Silos
  • Lack of Audit Trail
CERTAINTY

NexIndu Ecosystem (The Future)

  • Immutable Records (ALCOA+)
  • Verified Electronic Signatures
  • Automatic Regulatory Compliance

GxP Asset Control

Complete traceability of your equipment lifecycle, calibrations, and maintenance.

Operational Continuity

Robust 'Offline-First' architecture. Your production doesn't stop for connectivity failures.

Decision Support (AI)

Risk Analysis

"Nexi analyzes deviations in real-time by cross-referencing sensor data with your current SOPs."

Credential Vault

Access management and electronic signatures with military-grade encryption.

Inspection Peace of Mind

Designed under FDA 21 CFR Part 11 standards. We guarantee Data Integrity through immutable records and electronic signatures.

Immediate Return on Investment

~95%

Error Reduction

Eliminate manual transcription errors and GDP deviations through immutable electronic records.

15h+

Operational Efficiency

Recover 15+ hours per week per engineer in automated reporting.

360°

Total Visibility

Real-time monitoring of asset status and work orders.

Ready to digitize your plant under regulation?

NexIndu