GxP-Validated Enterprise Platform

The Platform Making Life Science Better for the Teams Behind Every Breakthrough

From quality management to lab operations, Voyantix delivers validated, integrated enterprise applications that eliminate compliance risk and accelerate your development pipeline.

5Integrated Products
99.9%Uptime SLA
8 wkGo-Live Timeline
21 CFRPart 11 Validated

Built for every regulated life science organization

Pharmaceutical Manufacturing
Biotech & Biopharma
Medical Device Companies
Contract Research Orgs
API Manufacturers
Clinical Laboratories
Why Voyantix

The only platform built exclusively for Life Sciences

Validated Out-of-Box

21 CFR Part 11 and EU Annex 11 compliant from day one. Every deployment ships with a full IQ/OQ/PQ validation documentation package — no extra effort required.

Fully Integrated Suite

QMS, LMS, DMS, LIMS, and HRMS share one unified data model. Training records link to CAPA actions. Lab deviations escalate to quality workflows automatically.

Implementation in Weeks

Not months. Pre-configured for pharma and biotech workflows, our proven delivery process gets you live and generating ROI in 8 weeks, not 18 months.

The Problem We Solve

Life Science Teams Are Drowning
in Manual Compliance Work

The average pharma quality team spends over 60% of their time on manual documentation, spreadsheet management, and chasing approvals — time that should be spent on science. Voyantix changes that.

The Problem

Spreadsheet-Based Quality Management

CAPA logs in Excel. Deviation trackers in shared drives. Audit schedules in email threads. No traceability, no real-time visibility, and every FDA inspection requires weeks of manual evidence gathering.

  • Average CAPA closure takes 47 days
  • No audit trail on spreadsheet changes
  • 483 observations for incomplete records
Voyantix QMS

Automated, Validated Quality Workflows

Digital CAPA workflows with automated escalations, real-time dashboards, and a complete electronic audit trail. FDA inspection readiness goes from weeks to hours.

  • CAPA closure time reduced by 40%
  • 21 CFR Part 11 compliant audit trail
  • Real-time inspection readiness score
40% faster closure · Zero paper
The Problem

Untracked GxP Training & Competency Gaps

Training records scattered across paper binders, LMS systems that don't talk to HR, and no visibility into which employees are qualified for which procedures. Regulators flag this constantly.

  • Training gaps discovered only at audit time
  • No link between training and job roles
  • Manual certificate tracking and renewal
Voyantix LMS + HRMS

Role-Based Training Matrix with Full Traceability

Automatically assign GxP training based on job roles. Track completion, certifications, and competency assessments in one place — linked directly to HR records and SOPs.

  • Training matrix auto-updated with org changes
  • Electronic signatures on all training records
  • Proactive alerts before certifications expire
100% training visibility · Audit-ready always
The Problem

Uncontrolled Documents & Version Chaos

SOPs printed and annotated by hand. Multiple "final" versions of the same document in circulation. Approval sign-offs via email. No way to know if floor staff are working from current versions.

  • Obsolete SOPs still in active use on shop floor
  • Approval cycles take 2–3 weeks by email
  • Document retrieval during inspections is chaotic
Voyantix DMS

Controlled Document Lifecycle, End-to-End

Single source of truth for all controlled documents. Automated version control, electronic approval workflows, and instant access to the current approved version — anywhere, on any device.

  • Document approval time cut by 65%
  • Zero obsolete documents in circulation
  • Instant document retrieval during inspections
65% faster approvals · Zero version confusion
The Problem

Lab Data Silos & Manual Sample Tracking

Sample results logged in instrument printouts, then manually re-entered into spreadsheets. OOS investigations tracked in notebooks. CoA generation takes days. Data integrity is a constant regulatory concern.

  • Manual re-entry errors in lab data
  • OOS investigation timelines consistently missed
  • CoA generation requires 2–3 days of manual work
Voyantix LIMS

Integrated Lab Operations with Full Data Integrity

Direct instrument integration eliminates manual re-entry. Automated OOS workflows trigger investigations instantly. CoAs generated in minutes from validated, electronic data — 21 CFR Part 11 compliant throughout.

  • Zero manual data re-entry from instruments
  • OOS investigations started automatically
  • CoA generation time reduced by 80%
80% faster CoA · Full data integrity

The net result for Voyantix customers

Across QMS, LMS, DMS, LIMS, and HRMS — Voyantix is designed to help teams recover an average of 18 hours per employee per month previously lost to manual compliance work. That's time reinvested in science.

18h
Saved per employee
per month
60%
Reduction in manual
compliance tasks
8 wk
Average time to
go-live
0
483 observations
from platform records
Products

Enterprise Applications Built for GxP

Five deeply integrated applications — each purpose-built for the regulatory complexity of life science organizations.

QMS — Quality Management

Stay inspection-ready every day with intelligent CAPA workflows and real-time quality dashboards.

  • CAPA & Deviation Management
  • Change Control & Audit Management
  • Risk Assessment & SOP Management
Learn More

LMS — Learning Management

Automate GxP training records, role-based curricula, and compliance certifications across your entire workforce.

  • GxP Training Tracking & Curricula
  • Electronic Signatures & Audit Trail
  • Competency Assessment & Matrix
Learn More

DMS — Document Management

Control every controlled document with electronic approval workflows and 21 CFR Part 11 eSignatures.

  • Controlled Document Lifecycle
  • Version Control & Archiving
  • Electronic Approval Workflows
Learn More

LIMS — Lab Information Management

Full chain-of-custody sample tracking from receipt to result release with instrument integration.

  • Sample Management & CoA Generation
  • Stability Studies & OOS Investigations
  • Environmental Monitoring
Learn More

HRMS — Human Resource Management

Manage your regulated workforce end-to-end — from GxP onboarding to qualification tracking and HR audit trails.

  • Employee Records & Onboarding Workflows
  • Role-Based Training Assignment
  • GxP Qualification Tracking
Learn More
View All Products
Solutions

Built for Every Life Science Organization

Whether you're a global pharma manufacturer or a CRO managing multi-site trials, Voyantix has a validated solution built for your world.

Pharmaceutical Manufacturing

Batch record management, deviation handling, supplier qualification, and GMP compliance — all in one integrated platform that keeps you inspection-ready every day.

Biotech & Biopharma

Scale from pre-clinical to commercial launch without rebuilding your compliance infrastructure. Voyantix grows with you from IND through BLA.

Medical Device Companies

ISO 13485, design control, risk management per ISO 14971, and FDA 21 CFR Part 820 — all supported out-of-box with no custom development required.

CROs & Research Institutes

Multi-site coordination, sponsor compliance requirements, and workforce training management — handled with the precision that clinical research demands.

Explore All Solutions
How It Works

From Implementation to Inspection-Ready in 8 Weeks

Our proven delivery process gets your team live, validated, and audit-ready — fast.

01

Discovery & Scoping

We map your processes, regulatory obligations, and integration requirements with our life science specialists.

02

System Configuration

Pre-configured workflows are tailored to your organization — no blank-canvas build, just smart adaptation.

03

Validation & Testing

Full IQ/OQ/PQ validation with UAT. You receive a complete documentation package ready for any regulator.

04

Go-Live & Training

Role-based training, dedicated CSM support, and 24/7 helpdesk from day one of your go-live.

By the Numbers

Platform designed for life science excellence

5
Integrated enterprise applications sharing one unified data model
8 wk
Average go-live timeline from contract to production deployment
21 CFR
Part 11 validated out-of-box with full IQ/OQ/PQ documentation
99.9%
Uptime SLA on GxP-validated cloud infrastructure
Platform Guarantees

Built to the Highest Standards

Voyantix is designed from the ground up for the world's most regulated industry. Every architectural, product, and operational decision is made with regulatory compliance as the non-negotiable baseline.

21 CFR Part 11 Validated

Every module ships with a complete validation package — URS, IQ, OQ, PQ, and GAMP 5-aligned documentation. Your team inherits our validation effort — no starting from scratch at go-live.

8-Week Go-Live Timeline

Our proven delivery process gets you live, validated, and inspection-ready within 8 weeks of contract signature — backed by a fixed milestone project plan from day one of engagement.

99.9% Uptime SLA

GxP-validated cloud infrastructure on AWS with 99.9% SLA, SOC 2 Type II controls, and ISO 27001-certified security management. Your compliance data is always available when you need it.

Dedicated Life Science CSM

Every Voyantix implementation includes a dedicated Customer Success Manager with pharma or biotech background. We measure our success in your clean inspection outcomes — not renewal rates.

Eliminate Compliance Risk Today

Ready to Eliminate
Compliance Risk?

Take the first step toward eliminating compliance friction. Our life science specialists will show you exactly how Voyantix maps to your workflows — tailored to your industry and regulatory obligations.

No commitment required  ·  Response within 1 business day  ·  NDA available on request