Life Science Compliance,
Solved for Your Industry
Every life science organization faces unique regulatory pressures. Voyantix is pre-configured for your industry's specific challenges — so you're compliant from day one.
GMP Compliance Without the Operational Friction
Batch failures, deviations, and inadequate CAPA systems are the leading causes of FDA Warning Letters and consent decrees in pharmaceutical manufacturing.
Voyantix delivers an integrated QMS + DMS + LMS + LIMS platform pre-configured for pharmaceutical manufacturing workflows. Every critical process — from batch record management and supplier qualification to environmental monitoring and periodic product review — is connected and fully auditable.
Scale from Research to Commercial Without Rebuilding
Too many biotech companies reach Phase III with paper-based quality systems and spend months in remediation before BLA submission — costing time and capital at the worst possible moment.
Voyantix gives biotech teams a GxP-validated platform that grows with them. Start with LIMS during research, add QMS when you enter Phase I, and expand to DMS + LMS + HRMS as your team and regulatory obligations scale. One platform, one validation effort, one data model — at every stage.
ISO 13485 and 21 CFR Part 820 — Compliant Out-of-Box
Design control, risk management per ISO 14971, and complaint handling are device-specific processes that generic quality platforms handle poorly — leaving gaps that regulators find immediately.
Voyantix QMS and DMS are pre-configured for ISO 13485 and FDA 21 CFR Part 820 with device-specific workflows for Design History Files, Technical Documentation, CAPA, and Complaint management. The risk management module natively supports FMEA and ISO 14971 risk file documentation.
Multi-Site Compliance Across Every Sponsor Requirement
CROs must satisfy their own quality system requirements while simultaneously meeting the diverse compliance standards of every sponsor — managing this complexity with spreadsheets is a recipe for audit findings.
Voyantix provides CROs with a single validated platform for multi-site quality management, sponsor-specific training curricula, and centralized document control — while giving each sponsor the segregated data visibility they need. Every study coordinator and investigator stays current on GCP training at all times.
Compliant with Global Regulatory Standards
Voyantix is designed to satisfy the requirements of every major global life science regulatory framework — out-of-box, without custom development.
Platform Outcomes Engineered for Life Science
Voyantix is built around measurable compliance outcomes. Here's what organizations implementing the platform are designed to achieve — validated into the workflow, not bolted on after.
Faster CAPA Closure Through Automated Workflows
Manual CAPA tracking in spreadsheets averages 45+ days to closure. Voyantix QMS replaces that with intelligent automated routing, deadline escalations, and real-time dashboards — designed to cut closure time by up to 40% from day one of go-live.
Explore QMSZero 483 Observations from Platform Records
Every module in Voyantix is built to satisfy FDA inspectors on day one. Complete audit trails, electronic signatures per 21 CFR Part 11, and instant record retrieval mean your CAPA history and training records are produced in minutes — not days.
Book a DemoDocument Approval Cycles Cut by 65%
Paper-based document control across multi-site organizations can take 3+ weeks per SOP. Voyantix DMS replaces email-based approvals with electronic workflows, parallel routing, and automated distribution — designed to reduce cycle time by up to 65%.
Explore DMSReady to See Voyantix in Your Industry?
Book a demo tailored to your specific industry, regulatory obligations, and current compliance challenges. Our specialists will show you exactly how Voyantix maps to your workflows.