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.
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, HRMS, EMS, E-Logs, and Cleaning Validation share one unified data model. Training records link to CAPA actions. Lab deviations escalate to quality workflows automatically. Environmental excursions trigger investigations. Cleaning failures open deviations. Every module works together — no integrations needed.
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.
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.
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
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
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
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
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
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
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
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%
Unmonitored Environmental Conditions
Temperature and humidity data logged manually on paper charts. Excursions discovered too late. No automated alerts when cleanroom conditions drift out of range. Environmental data lives in spreadsheets disconnected from quality workflows.
- Excursions detected hours after they occur
- Paper chart recordings prone to human error
- No automated link to deviation management
Real-Time Environmental Monitoring
Continuous sensor-based monitoring with automated excursion alerts. Environmental data flows directly into quality workflows — excursions trigger deviations automatically. Full 21 CFR Part 11 compliant data logging.
- Instant alerts when conditions exceed limits
- Automated deviation trigger on excursions
- Trend analysis across rooms and time periods
Paper-Based Logbooks & Batch Records
Equipment logs, cleaning logs, and batch records kept in paper binders. Entries illegible, missing, or backdated. No electronic signatures. Auditors spend hours reviewing paper records with no way to search or verify authenticity.
- Missing or incomplete log entries
- No audit trail on paper record changes
- Batch record review takes days of manual work
Paperless Electronic Logbooks
Replace paper logbooks with structured electronic entries. Every entry captured with electronic signatures, timestamps, and complete audit trails. Batch records, equipment logs, and cleaning logs — all 21 CFR Part 11 compliant.
- Zero missing entries with structured data capture
- Complete tamper-evident audit trail on every record
- Instant search and retrieval during inspections
Manual Cleaning Validation Tracking
MACO calculations in spreadsheets. Sampling plans on paper. Cleaning validation protocols tracked in shared drives with no version control. Cross-contamination risk management relies on tribal knowledge and manual reconciliation.
- MACO calculations prone to human error
- No centralized tracking of validation lifecycle
- Change control for cleaning procedures is chaotic
Digital Cleaning Validation Lifecycle
Automated MACO calculations based on HBEL limits. Digital protocol execution with electronic signatures. Centralized tracking from risk assessment through ongoing monitoring — all 21 CFR Part 11 compliant.
- Automated MACO and residue limit calculations
- Digital protocol execution with audit trails
- Lifecycle tracking from design to ongoing verification
The net result for Voyantix customers
Across QMS, LMS, DMS, LIMS, HRMS, EMS, E-Logs, Cleaning Validation, and CAPS — 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.
per month
compliance tasks
go-live
from platform records
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.
CROs & Research Institutes
Multi-site coordination, sponsor compliance requirements, and workforce training management — handled with the precision that clinical research demands.
From Implementation to Inspection-Ready in 8 Weeks
Our proven delivery process gets your team live, validated, and audit-ready — fast.
Discovery & Scoping
We map your processes, regulatory obligations, and integration requirements with our life science specialists.
System Configuration
Pre-configured workflows are tailored to your organization — no blank-canvas build, just smart adaptation.
Validation & Testing
Full IQ/OQ/PQ validation with UAT. You receive a complete documentation package ready for any regulator.
Go-Live & Training
Role-based training, dedicated CSM support, and 24/7 helpdesk from day one of your go-live.
Platform designed for life science excellence
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.
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