MOCRA & FDA Compliance Ready

Regulatory Compliance Made Simple

AI-powered document generation combined with expert oversight. Equipment validation tracking, calibration management, and complete audit trails for pharmaceutical, nutraceutical, and cosmetic manufacturing.

500+
Documents Managed
99.9%
Uptime SLA
24hr
Support Response
Dashboard Preview

Why Choose Validation Labs?

The perfect balance of AI efficiency and human expertise for manufacturing compliance.

AI-Powered Generation

Accelerate document creation with intelligent templates that understand regulatory requirements and your specific processes.

Expert Oversight

Every AI-generated document is reviewed by Subject Matter Experts to catch critical technical details that pure automation misses.

Complete Audit Trails

21 CFR Part 11 compliant electronic records with immutable audit logs, electronic signatures, and full traceability.

Equipment Validation

Full lifecycle equipment management from URS through IQ/OQ/PQ with automated scheduling and requalification tracking.

Smart Scheduling

Automated calibration and maintenance scheduling with email notifications, dashboard alerts, and overdue tracking.

Multi-Tenant Ready

Enterprise-grade security with complete data isolation between clients, role-based access control, and SSO support.

Modular Platform

Choose the modules you need. Scale as you grow.

Calibration Tracker

Complete calibration lifecycle management with automated scheduling and compliance reporting.

  • Automated due date calculations
  • Certificate management
  • Tolerance tracking
  • Vendor integration

Preventive Maintenance

Keep equipment running at peak performance with scheduled maintenance and work order management.

  • PM schedule templates
  • Work order tracking
  • Parts inventory
  • Downtime analysis

Document Control

FDA-compliant document management with version control, approval workflows, and electronic signatures.

  • Version control
  • Review workflows
  • E-signatures
  • SHA-256 integrity

Training Management

Track personnel qualifications, certifications, and GMP training requirements with automated reminders.

  • Training matrices
  • Certification tracking
  • Competency assessments
  • Retraining alerts

Audit Management

Internal audit scheduling, finding tracking, CAPA management, and regulatory inspection preparation.

  • Audit scheduling
  • Finding tracking
  • CAPA integration
  • Inspection prep

Compliance Dashboard

Real-time visibility into your compliance status with KPIs, trend analysis, and executive reporting.

  • Real-time KPIs
  • Trend analysis
  • Executive reports
  • Regulatory alerts

Transform Your Compliance Operations

See measurable results from day one with our proven implementation methodology.

1

Reduce Documentation Time by 70%

AI-powered templates generate compliant documents in minutes instead of hours, freeing your team for higher-value work.

2

Eliminate Missed Calibrations

Automated scheduling and notifications ensure no equipment falls out of compliance, with escalation workflows built in.

3

Inspection-Ready at All Times

Complete audit trails and instant access to all records means you're always prepared for regulatory inspections.

4

Enterprise Features, SMB Pricing

Get capabilities that large pharma companies have at a price point that makes sense for growing facilities.

Ready to Simplify Your Compliance?

Schedule a personalized demo to see how Validation Labs can transform your manufacturing operations.