Industry Solutions

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.

Pharmaceutical Manufacturing

GMP Compliance Without the Operational Friction

The Challenge

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.

Batch Record ManagementElectronic review and approval with 21 CFR Part 11 e-signatures
Deviation & CAPAStructured workflows per 21 CFR Part 211 with root cause tracking
Supplier QualificationApproved Vendor List management with audit and re-qualification workflows
Annual Product ReviewAutomated data aggregation across batches, deviations, and complaints
Environmental MonitoringAlert thresholds, trending, and out-of-spec event management
GMP TrainingSOP-linked training curricula with role-based compliance tracking
Regulatory Standards
21 CFR Part 211 21 CFR Part 11 GMP ICH Q10 EU Annex 11 GAMP 5
Voyantix Products
QMS DMS LMS LIMS HRMS
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Biotech & Biopharma

Scale from Research to Commercial Without Rebuilding

The Challenge

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.

Scalable ArchitectureGrows from 10-person research teams to large commercial organizations
CAPA for BiologicsComplex deviation and CAPA workflows for biologics and gene therapy programs
FDA Readiness DashboardSubmission-aligned readiness tracking for BLA and NDA timelines
Sample & Cell Line ManagementFull chain-of-custody for biological samples in GxP LIMS
Cross-Functional DeviationsUnified deviation management across research and manufacturing sites
Clinical Supply DocumentationQuality documentation support for clinical supply chain operations
Regulatory Standards
IND / BLA / NDA 21 CFR Part 11 GxP ICH Q10 EU Annex 11 GAMP 5
Voyantix Products
QMS LIMS LMS DMS
Book a Biotech Demo
CROs & Research Institutes

Multi-Site Compliance Across Every Sponsor Requirement

The Challenge

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.

Multi-Site Quality ManagementSite-level quality data with centralized oversight and cross-site trending
Sponsor-Specific TrainingSeparate training curricula per sponsor with individual compliance reporting
Centralized Document ControlSite-level access management with sponsor data segregation built in
GCP & GLP Training TrackingRole-based training assignments for all study and investigator staff
Protocol Deviation ManagementSponsor notification workflows and deviation reporting per ICH E6(R2)
Audit ManagementScheduling and tracking for both sponsor-led and regulatory authority audits
Regulatory Standards
GCP GLP 21 CFR Part 11 ICH E6(R2) EU Annex 11 GAMP 5
Voyantix Products
QMS LMS DMS HRMS
Book a CRO Demo
Regulatory Coverage

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.

21 CFR Part 11 FDA Electronic Records & Signatures
EU Annex 11 Computerised Systems in GMP
GxP Good Practice Guidelines
ICH Q10 Pharmaceutical Quality System
GAMP 5 Computerised System Validation
ISO 9001 Quality Management Systems
Designed for Results

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.

40%
Reduction in CAPA closure time
0
483 observations from platform records
65%
Faster document approval cycles
40%

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.

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0

Zero 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.

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65%

Document 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%.

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Personalized Demo

Ready 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.