Nexgensis TechnologiesNexgensisTechnologies

Configured for your regulatory reality

Each industry arrives with its own content pack: workflows, forms, terminology and reports that inspectors in that sector expect to see.

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Content packs shipped

  • Pharmaceutical
  • API Manufacturing
  • Formulation
  • Medical Devices
  • Food & Beverage
  • FMCG
  • Chemical
  • Manufacturing
  • Automotive
  • Biotechnology

Each pack ships pre-configured workflows, forms and inspection reports.

Pharmaceutical manufacturing

Pharmaceutical

End-to-end GxP digitization for regulated drug product manufacturing.

Deployed Solutions

  • eBMR
  • eQMS
  • LIMS
  • APQR

Challenges Today

  • Paper-heavy batch records
  • Regulatory inspection exposure
  • Slow batch release

Business Outcomes

  • 58% faster batch release
  • Zero critical 483 observations
  • Real-time QA oversight
Talk to a Pharmaceutical specialist
API Manufacturing manufacturing

API Manufacturing

Process-intensive control for active pharmaceutical ingredient plants.

Deployed Solutions

  • eBMR
  • eLogs
  • LIMS
  • AI Analytics

Challenges Today

  • Complex multi-step processes
  • Yield variability
  • Cleaning validation load

Business Outcomes

  • Yield variance down 22%
  • Faster campaign changeover
  • Traceable cleaning records
Talk to an API Manufacturing specialist
Formulation manufacturing

Formulation

High-mix finished dosage operations with tight release timelines.

Deployed Solutions

  • eBMR
  • DMS
  • LMS
  • eQMS

Challenges Today

  • High SKU complexity
  • Line clearance errors
  • Packaging reconciliation

Business Outcomes

  • Right-first-time up 31%
  • Line clearance in minutes
  • Fewer packaging deviations
Talk to a Formulation specialist
Medical Devices manufacturing

Medical Devices

ISO 13485 and 21 CFR Part 820 aligned quality systems.

Deployed Solutions

  • eQMS
  • DMS
  • LMS
  • AI Analytics

Challenges Today

  • Design history file control
  • Complaint and MDR handling
  • Supplier quality

Business Outcomes

  • Complaint cycle time halved
  • Audit-ready DHF
  • Supplier scorecards live
Talk to a Medical Devices specialist
Food & Beverage manufacturing

Food & Beverage

HACCP, FSSC 22000 and traceability across high-volume production.

Deployed Solutions

  • LIMS
  • eLogs
  • eQMS
  • EAM

Challenges Today

  • Recall traceability
  • Shelf-life testing load
  • Hygiene compliance

Business Outcomes

  • Trace in under 4 minutes
  • Lab throughput up 40%
  • Paperless hygiene checks
Talk to a Food & Beverage specialist
FMCG manufacturing

FMCG

High-velocity consumer goods lines where every changeover is a release decision.

Deployed Solutions

  • eQMS
  • LIMS
  • eLogs
  • DMS

Challenges Today

  • Rapid SKU and artwork churn
  • Multi-plant spec drift
  • Batch traceability for recalls

Business Outcomes

  • Changeover quality checks paperless
  • Single spec master across plants
  • Recall trace in under 5 minutes
Talk to an FMCG specialist
Chemical manufacturing

Chemical

Safety, specification and environmental compliance in one system.

Deployed Solutions

  • eQMS
  • LIMS
  • EAM
  • AI Analytics

Challenges Today

  • EHS incident tracking
  • Spec conformance
  • Multi-site standardization

Business Outcomes

  • Incident closure 2x faster
  • Unified multi-site specs
  • Lower rework cost
Talk to a Chemical specialist
Manufacturing manufacturing

Manufacturing

Discrete and process plants moving to connected digital quality.

Deployed Solutions

  • eBMR
  • EAM
  • eQMS
  • AI Analytics

Challenges Today

  • Disconnected shopfloor systems
  • Scrap and rework
  • Downtime visibility

Business Outcomes

  • Downtime down 27%
  • Scrap reduced 19%
  • Live OEE-linked quality
Talk to a Manufacturing specialist
Automotive manufacturing

Automotive

IATF 16949 aligned quality for OEM and tier-1 component supply chains.

Deployed Solutions

  • eQMS
  • DMS
  • EAM
  • AI Analytics

Challenges Today

  • PPAP and APQP paperwork load
  • Supplier PPM and line rejections
  • Customer audit readiness

Business Outcomes

  • PPAP packs assembled 4x faster
  • Supplier PPM down 34%
  • IATF audit evidence on demand
Talk to an Automotive specialist
Biotechnology manufacturing

Biotechnology

Bioprocess data integrity from development through commercial supply.

Deployed Solutions

  • ELN
  • LIMS
  • eBMR
  • APQR

Challenges Today

  • Tech transfer gaps
  • Complex analytics
  • Comparability evidence

Business Outcomes

  • Tech transfer 6 weeks faster
  • Structured comparability data
  • Inspection confidence
Talk to a Biotechnology specialist