Paper SOPs
Uncontrolled copies and manual distribution.
Nexgensis Technologies — AI-Powered Unified Quality Platform for Regulated Manufacturing
Nexgensis OPS IQ
Live in production
AI-native quality intelligence, live in production
AI-Powered Unified Quality Platform for Regulated Manufacturing
Digitize Quality, Laboratory, Manufacturing, Asset Management and Compliance with one integrated platform designed for Pharmaceutical, Automotive, FMCG, Food & Beverage, Chemical and Medical Device manufacturers.
Still Managing Quality with Paper, Excel & Multiple Systems?
Regulated manufacturers lose weeks of throughput and carry avoidable inspection risk because quality operations remain fragmented.
Manual CAPA
Spreadsheet tracking with no effectiveness checks.
Audit Delays
Weeks spent assembling evidence for inspectors.
Batch Release Delays
Sequential paper review holds product.
Disconnected Systems
QMS, LIMS and MES that never talk.
Poor Traceability
No thread from raw material to release.
Compliance Risks
Data integrity gaps discovered too late.
No Real-Time Visibility
Leadership reporting is always retrospective.
OPS IQ — One Platform for Every Quality Workflow
OPS IQ stands for Operations Process Suite with Integrated Quality — a unified architecture where quality, laboratory, manufacturing and asset data share one model, so intelligence and compliance work across the whole operation.
Ten enterprise products. Pick your starting point.
From the QMS to the lab bench to the shop floor — see what each product does and the workspace your teams will use.
Quality Layer
eQMS
Enterprise Quality Management
Unify deviations, CAPA, change control, complaints and audits in one validated, workflow-driven quality system.
- Deviation & CAPA
- Change Control
- Audit Management
Built for the realities of regulated production
Every industry carries its own inspection expectations. Nexgensis ships pre-configured content for each one.
Industry 01 / 10
Pharmaceutical
End-to-end GxP digitization for regulated drug product manufacturing.
Challenges we remove
- Paper-heavy batch records
- Regulatory inspection exposure
- Slow batch release
Outcomes
- 58% faster batch release
- Zero critical 483 observations
- Real-time QA oversight
Intelligence Built Into Daily Operations
Not a bolt-on copilot. AI runs inside deviations, batches, documents and lab data — grounded in your validated records and permission model.
AI Root Cause Analysis
Surfaces the most probable causes for a deviation by correlating historical events, equipment and batch context.
Predictive Quality
Flags batches and processes trending toward specification limits before they fail.
Smart Search
Semantic, natural-language search across SOPs, records, investigations and lab data.
Deviation Intelligence
Auto-classifies, deduplicates and recommends CAPA effectiveness checks.
Risk Prediction
Scores suppliers, sites and processes on emerging compliance risk.
Document Intelligence
Extracts obligations and change impact from controlled documents automatically.
Executive AI Dashboards
Narrated quality summaries for leadership, refreshed continuously.
Intelligent Recommendations
Suggested next actions surfaced inside investigations, reviews and approvals.
Natural Language Query
“Show every overdue CAPA at Site B linked to blend uniformity deviations.”
4 CAPAs
Overdue
2 shared
Root causes
11 days
Avg. delay
Enterprise-grade from day one
Platform
Built to scale
Cloud Native
Multi-tenant, elastic and continuously delivered.
Configurable Workflows
No-code workflow studio, no custom builds.
Enterprise APIs
Integrates with SAP, MES and ERP systems.
Mobile Ready
Shopfloor and lab tasks on any device.
Trust
Audit-ready by design
Role Based Security
Granular, site-aware permission model.
Audit Trails & e-Signatures
Every record change traced and signed, by design.
Record-level Data Integrity
ALCOA++ principles enforced on every record.
Computerised System Controls
Annex 11 controls built into the platform, not bolted on.
See OPS IQ in Motion
Experience how OPS IQ transforms quality operations with real-time dashboards, intelligent workflows, and complete process visibility.
Accelerating Enterprise Digital Transformation
Helping enterprises modernize their data platforms, build intelligent AI solutions, and unlock business value through advanced data engineering.
Built against the standards your auditors already use
Quality management, GMP batch manufacturing, data integrity and risk — the frameworks the platform is configured and validated against, across every sector we serve.
ISO 90012015Quality management systemsIATF 169492016Automotive quality managementFSSC 22000v6Food safety system certification21 CFR 211cGMP for finished pharmaceuticalsEU GMP Annex 1Sterile medicinal productsSchedule M+Revised Indian GMP requirements21 CFR Part 11Electronic records and signaturesGAMP 52nd ed.Risk-based computerised validationMHRA GxPData integrity expectationsISO 149712019Medical device risk managementISO 450012018Occupational health & safety
ISO 134852016Medical device quality systemsICH Q10Pharmaceutical quality systemISO 220002018Food safety management21 CFR 820Quality System RegulationWHO GMPTRS 986Good manufacturing practicePIC/S GMPHarmonised GMP inspectionEU GMP Annex 11Computerised systemsALCOA++Data integrity attributesICH Q9Quality risk managementISO 270012022Information security managementISO 140012015Environmental management
A validated path to go-live in 8–12 weeks
01
Discovery
Process mapping, gap analysis and success metrics agreed with your quality leadership.
02
Configuration
Your workflows, forms, roles and sites set up in your own tenant.
03
Validation
IQ/OQ/PQ execution using our pre-approved GAMP 5 package.
04
Training
Role-based enablement for QA, lab, production and IT super-users.
05
Go Live
Cutover with hypercare and parallel-run support on the floor.
06
Support
24×7 global support, quarterly releases and continuous improvement reviews.
Questions enterprise buyers ask us
Most single-site deployments reach production in 8 to 12 weeks, including configuration, validation and training. Multi-site rollouts run as staged waves after the first site is live.
Ready to Transform Your Quality and Data Operations?
Whether it starts with OPS IQ or a data and AI engagement, our team will help you scope the right first step.