21 CFR Part 11 Compliant · GxP Validated
AI-Driven Platform for
Pharma & Manufacturing
Excellence
From electronic batch records to end-to-end quality and risk management, Nexgensis digitizes and governs the complete manufacturing lifecycle—delivering compliance, traceability, and operational intelligence. Trusted by leading pharmaceutical and chemical manufacturers across India.
Alert: Deviation detected on Line-2 Reactor — temperature exceeded ±2°C threshold for batch BT-4824. Initiating CAPA workflow.
Root Cause Identified: Calibration drift on thermocouple TC-07. Last calibrated 48 days ago — exceeds 30-day PM schedule. Auto-linked to DEV-1192.
CAPA #C-4821 created. Assigned to QA Lead. Corrective action: immediate recalibration of TC-07. Preventive action: PM schedule tightened to 21-day cycle for all Line-2 sensors.
Batch BT-4824 status: Hold. Impacted material quarantined. Notified Plant Head & QA Manager via email + SMS. Awaiting review before release.
✓ All actions logged. Full audit trail recorded with e-signatures. 21 CFR Part 11 compliant. No manual intervention needed.
NexA AI is monitoring 320 sensors across 3 plants...➤
BT-4824Metformin 500mgHold
BT-4823Omeprazole 20mgReleased
Data Integrity Ready
ALCOA++ · Audit Trail · eSign
20+
Plants Live
Quality Management System
Paperless Quality.
Zero Compliance Gaps.
opsIQ — unified quality management for document control, CAPA, deviations, change control, audits, and training — with built-in 21 CFR Part 11 compliance and real-time dashboards.
CAPA IDRoot CauseStatus
CA-1042Equipment failureClosed
CA-1043Process deviationIn Progress
CA-1044Contamination riskOverdue
CA-1045SOP non-complianceClosed
SOP-142Cleaning ValidationApproved
SOP-155Equip QualificationPending
60% Faster CAPA
Automated escalations
Pharma Manufacturing Intelligence
PharmIQ AI.
Predict. Prevent. Optimize.
AI-powered predictive analytics trained on pharmaceutical manufacturing data. Detect deviations before they occur, identify root causes in seconds.
EventRoot CauseConfidence
DEV-312Temp excursion96%
DEV-313Mixer speed drift91%
DEV-314Raw material variability87%
DEV-315Humidity spike83%
Yield+2.1% MoM↑
Deviations-18% MoM↓
94% Accuracy
ML-powered detection
Manufacturing Intelligence Platform
ProcessIQ AI.
Smart Factories. Smarter Decisions.
AI-driven manufacturing intelligence for chemicals, adhesives, FMCG, auto components, and discrete manufacturing. Predictive maintenance, yield optimization, and real-time OEE — across every production line.
AssetHealth ScoreStatus
Reactor R-0196%Healthy
Mixer M-0378%Monitor
Dryer D-0262%At Risk
Compressor C-0191%Healthy
Line-3Changeover45 min
Line-7PM SchedulePlanned
Cross-Industry AI
Chemical · FMCG · Auto · Discrete
87%
OEE Achieved
Unified Platform Architecture
Nexgensis
NexA AI
AI Copilot
opsIQ
Quality Mgmt
BatchGenius
Batch Records
IntelliLabs
Lab Mgmt
IntelliAsset
Asset Mgmt
APQR
Quality Review
EWS
Early Warning
PharmIQ AI
Analytics
One Platform20+ years in pharma IT
8
Modules
1
Platform
0
Silos
Why Nexgensis
Purpose-Built for
Pharma & Manufacturing
Not a generic platform retrofitted for compliance — every module enforces data integrity by design.
Pharma-Native Architecture
Audit trails, eSignatures, and ALCOA++ built in from day one — not an afterthought.
AI That Understands Manufacturing
PharmIQ AI trained on manufacturing data — predicting deviations and optimizing batch cycles.
90-Day Go-Live
Pre-configured workflows for pharma, chemical, and FMCG. Deploy in weeks, not quarters.
60% Lower TCO
Compared to TrackWise and MasterControl. Cloud-native SaaS with no hidden costs.
Unified Platform
opsIQ, BatchGenius, IntelliLabs, IntelliAsset, APQR — one source of truth with NexA AI in every module.
Platform Suite
One Platform. Complete Manufacturing Control.
Eight integrated modules covering every step from raw material to finished product release — with an AI copilot in every module.
NexA AI — Your Manufacturing Copilot
An AI-powered chat agent embedded in every Nexgensis module. Ask questions in natural language, get instant answers from your manufacturing data, generate reports, and navigate complex workflows — all through conversation.
- ✓ Conversational AI embedded in opsIQ, BatchGenius, IntelliLabs & more
- ✓ Natural language queries across all manufacturing data
- ✓ Instant report generation — "Show me last month's CAPA summary"
- ✓ Guided workflows & SOP assistance for shop floor operators
- ✓ Context-aware — understands your role, plant, and compliance needs
NexA AI
Online — ready to help
opsIQ
BatchGenius
IntelliLabs
Show me last month's CAPA summary for Plant-3
Here's the CAPA Summary for Plant-3 (Jan 2026):
Open CAPAs4
Closed (on-time)12
Overdue1
Avg closure time6.2 days
What's the root cause trend for the overdue one?
CAPA #C-4821 is overdue by 3 days. Root cause: Equipment calibration drift on Line-2 reactor. Linked to Deviation DEV-1192. Recommended action: Schedule preventive maintenance via IntelliAsset.
📊 Batch yield report
⚠️ Open deviations
📋 Pending approvals
🔬 OOS results today
Industries We Serve
Single Platform.Serving Multi Industries
Configurable workflows and compliance templates for every regulated manufacturing environment.
GMP
21 CFR Part 11
ALCOA++
Pharmaceutical
Complete GMP compliance for API, formulation, and packaging units — covering batch records, deviations, CAPA, and full audit readiness.
ISO 9001
Safety
SDS
Specialty Chemicals
Batch process optimization, safety data sheets, and EHS compliance for chemical plants with automated SOPs and real-time process controls.
🧴📦🍞🥛
FSSAI
HACCP
ISO 22000
FMCG & Food Processing
FSSAI, HACCP, and ISO 22000 workflows for food safety — with end-to-end traceability, hygiene audits, and regulatory compliance built in.
IoT
Real-time
OEE
Manufacturing
Discrete and process manufacturing with IoT-enabled monitoring, real-time dashboards, asset tracking, and OEE metrics for operational excellence.
What Clients Say
Trusted by Quality Leaders
Head of Asset Management
Maintenance & Reliability
⭐⭐⭐⭐⭐
IntelliAsset gave us full lifecycle visibility across 500+ equipment. Predictive maintenance alerts from EWS prevented 3 major breakdowns last quarter alone.
500+
Assets Tracked
3
Failures Prevented
Head of Quality Assurance
Quality & Compliance
⭐⭐⭐⭐⭐
The opsIQ implementation helped us become audit-ready 24/7. Our CAPA closure time dropped by 60%, and the quality team now has full visibility across all deviations.
60%
Faster CAPA
24/7
Audit Ready
VP Manufacturing Operations
Operations Leadership
⭐⭐⭐⭐⭐
Nexgensis transformed our batch manufacturing process across 20+ plants. The transition from paper to digital was seamless and real-time visibility has been a game-changer.
20+
Plants Live
100%
Paperless
Director of Mfg Excellence
Manufacturing & Engineering
⭐⭐⭐⭐⭐
PharmIQ AI and IntelliAsset have given us predictive visibility into equipment health. We reduced unplanned downtime by 35% and NexA AI made adoption smooth.
35%
Less Downtime
3x
Faster Adoption
Head of Asset Management
Maintenance & Reliability
⭐⭐⭐⭐⭐
IntelliAsset gave us full lifecycle visibility across 500+ equipment. Predictive maintenance alerts from EWS prevented 3 major breakdowns last quarter alone.
500+
Assets Tracked
3
Failures Prevented
Head of Quality Assurance
Quality & Compliance
⭐⭐⭐⭐⭐
The opsIQ implementation helped us become audit-ready 24/7. Our CAPA closure time dropped by 60%, and the quality team now has full visibility across all deviations.
60%
Faster CAPA
24/7
Audit Ready
VP Manufacturing Operations
Operations Leadership
⭐⭐⭐⭐⭐
Nexgensis transformed our batch manufacturing process across 20+ plants. The transition from paper to digital was seamless and real-time visibility has been a game-changer.
20+
Plants Live
100%
Paperless
Director of Mfg Excellence
Manufacturing & Engineering
⭐⭐⭐⭐⭐
PharmIQ AI and IntelliAsset have given us predictive visibility into equipment health. We reduced unplanned downtime by 35% and NexA AI made adoption smooth.
35%
Less Downtime
3x
Faster Adoption
Customer Results
Real Impact. Measurable Outcomes.
Going Paperless at Scale
Chemicals & Adhesives · Multi-Plant
Case Study
Digitized 20+ Plants with Unified Batch Records
Replaced paper-based batch records and logbooks across all manufacturing sites, achieving real-time visibility, faster batch release, and zero paper dependency.
BatchGenius
opsIQ
NexA AI
20+
Plants Live
40%
Faster Release
Zero
Paper
Audit-Ready in 60 Days
Pharma Manufacturing · Global Ops
Case Study
Achieving 24/7 Compliance with Electronic QMS
Implemented electronic quality management meeting WHO PQ, FDA, and EMA standards — with automated CAPA workflows and real-time deviation tracking.
opsIQ
APQR
IntelliLabs
100%
Audit Ready
60%
Faster CAPA
24/7
Compliance
Predictive Maintenance at Scale
Auto Components · Multi-Site
Case Study
AI-Driven Asset Monitoring Across Manufacturing Sites
Deployed predictive maintenance and AI-driven production optimization — reducing unplanned downtime, improving OEE, and boosting overall yield.
PharmIQ AI
IntelliAsset
EWS
35%
Less Downtime
87%
OEE Achieved
4.8%
Yield Uplift
Regulatory Compliance
Built for the Most Stringent Regulations
Every module meets global pharma regulatory requirements out of the box.
- ✓ Complete 21 CFR Part 11 with electronic signatures & audit trails
- ✓ EU Annex 11 computerized system validation support
- ✓ ALCOA++ data integrity at every data capture point
- ✓ IQ/OQ/PQ validation documentation included
- ✓ Role-based access with segregation of duties
21 CFR Part 11
FDA electronic records & signatures
EU Annex 11
European computerized systems
ALCOA++
Complete data integrity principles
GxP Validated
GMP, GLP, GDP compliant
Data Integrity
Tamper-proof audit trails
CSV Ready
IQ/OQ/PQ documentation
Ready to Digitize Your Manufacturing?
See how Nexgensis eliminates paper, accelerates batch release, and keeps you inspection-ready — across every site.
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Contact With Us!
2220 Plymouth Rd #302, Hopkins, Minnesota(MN), 55305
Call us: (234) 109-6666
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