Life Sciences Regulatory Intelligence Platform

Regulatory Intelligence for Life Sciences Compliance Teams

ComplianceBI empowers quality, regulatory affairs, compliance, and audit teams in pharmaceutical, biotech, and CDMO organizations with the intelligence needed to stay ahead of FDA, EMA, and global health authority inspections.
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  • Identify FDA 483 & regulatory risks early
  • Prevent repeat observations across sites
  • Multi-site compliance visibility
  • Inspection-ready confidence for life sciences

The Compliance Challenge in Life Sciences

Quality, regulatory, compliance, and audit teams in pharmaceutical, biotech, and CDMO organizations operate under constant pressure. FDA, EMA, MHRA, and global health authority expectations evolve continuously, and compliance risks often remain hidden until an inspection exposes them.

Teams struggle with:

Missed patterns across past inspections

Repeat observations that damage credibility

Limited visibility across multiple sites

Manual analysis that delays corrective action

Uncertainty before inspections

ComplianceBI exists to remove this uncertainty.

The Challenge
Constant Regulatory Signals

FDA 483s

Inspectional observations

Warning Letters

Critical compliance failures

Global Reports

EMA, MHRA, Health Canada

Public Databases

Industry-wide data

Analyzes

ComplianceBI

Intelligence Layer

Delivers

The Outcome
Orchestrated Action

Focused CAPAs

SOP Updates

Training Gaps

Audit Readiness

We help you:

Understand what regulators are focusing on now

See which risks apply to your operations and sites

Identify SOP, training, and CAPA gaps early

Take corrective action before issues escalate

Life Sciences Regulatory Intelligence Platform

Everything You Need for Inspection Readiness

A seamless workflow from data to action

Ingest

Global regulatory data flows in automatically

Analyze

AI identifies patterns, trends, and emerging risks

Alert

Site-specific risks surfaced with clear context

Act

Automated CAPAs, SOP updates, and training plans

Click on any card to explore detailed capabilities

Regulatory Intelligence

Analyze FDA 483s and inspection data to identify trends, patterns, and emerging risks relevant to your operations.

Regulatory Intelligence

  • Real-time FDA 483 observation tracking and analysis
  • Pattern recognition across therapeutic areas and facility types
  • Benchmarking against industry peers and competitors
  • Early warning alerts for emerging regulatory focus areas
  • Historical trend analysis for proactive risk mitigation

Predictive Readiness

Understand which observations are most likely to occur next and where vulnerabilities exist across SOPs, training, and processes.

Predictive Readiness

  • AI-powered prediction of likely inspection observations
  • Gap analysis against current GMP requirements
  • SOP vulnerability mapping and recommendations
  • Training effectiveness correlation analysis
  • Risk scoring for each compliance area

Site Level Visibility

Compare risk and readiness across all sites to ensure consistent quality and compliance performance.

Site Level Visibility

  • Unified dashboard for multi-site compliance status
  • Site-by-site risk comparison and benchmarking
  • Cross-site trend identification and best practices
  • Resource allocation optimization recommendations
  • Standardized compliance metrics across facilities

Automated Execution

Convert insights into CAPA tasks, SOP recommendations, training guidance, and draft responses automatically.

Automated Execution

  • Auto-generated CAPA plans from identified gaps
  • AI-drafted SOP revision recommendations
  • Automated training assignment workflows
  • FDA response letter templates and guidance
  • Integration with existing QMS and CAPA systems

The Compliance Challenge in Life Sciences

Stay ahead of inspections

Know where risks exist before inspectors identify them.

Prevent repeat observations

Address systemic issues early and strengthen controls proactively.

Reduce preparation time

Automate analysis and action instead of relying on manual reviews.

Maintain consistency across sites

Ensure every facility meets the same compliance standards.

Increase confidence

Walk into inspections with clarity and control.

See ComplianceBI in Action

The Compliance Challenge in Life Sciences

ComplianceBI complements your existing QMS and LMS systems.

Quality & Manufacturing

  • Veeva QMS
  • TrackWise
  • MasterControl
  • Werum PAS-X
  • LabWare

Regulatory & Training

  • Veeva RIM
  • Cornerstone LMS
  • Workday HCM
  • SAP SuccessFactors

Enterprise Analytics

  • Power BI
  • Tableau
  • ServiceNow
  • Jira
Doesn’t replace your systems — makes them smarter
  • What actions need to be taken
  • Which SOPs require updates
  • Where training gaps exist
Execution continues within your current systems while ComplianceBI provides the intelligence layer that drives the right actions.

Who We Serve

ComplianceBI is built for life sciences professionals across:

Quality Assurance & Quality Control leaders

Compliance & Audit teams

Limited visibility across multiple sites

Site Quality & Operations heads

CAPA & Deviation management teams

Multi-site manufacturing organizations

Our Purpose

Quality teams carry the responsibility of protecting product integrity and patient trust.

ComplianceBI supports the people responsible for safeguarding quality by giving them clarity, confidence, and control in an increasingly complex regulatory environment

Ready to See How ComplianceBI Helps Quality Teams Stay Ahead of Regulatory Risk?

Request a Demo