Revolutionizing GxP System Management
What is Phanero?
Phanero is a GxP computerized systems management platform that simplifies compliance and accelerates digital transformation.
It empowers teams with faster go-lives, proactive risk oversight, and built-in audit readiness — all within one unified system.
Reduce Burden
Automate tracking and compliance tasks to eliminate manual overhead.
Accelerate Time
Streamline system validation to reduce time to live (TTL) for digital initiatives.
Ensure Efficiency
Gain full visibility and control with centralized risk and performance insights.
Be Audit-Ready
Stay inspection-ready with real-time reports and role-based accountability.
Industry Challenges: The Need for Modern Compliance Strategies
Outdated Approaches
Legacy compliance methods — like spreadsheets and static repositories — slow down digital transformation and hinder scalability.
Regulatory Complexity
Navigating regulations such as FDA 21 CFR Part 11 and EU Annex 11 is increasingly demanding, especially when applying evolving guidance like GAMP.
Reporting Blind Spots
Limited real-time visibility and fragmented data make it difficult to stay audit-ready or support timely decision-making.
Limited CSA Experience
Organizations often lack hands-on experience with modern lean validation frameworks like Computer Software Assurance (CSA) and risk-based testing.
Real-time inventory updates.
SaaS, cloud & on-premise oversight.
Role-based access control & SSO.
AI Integrations
What Teams Are Struggling With
Unvalidated Systems
Relying on Excel and SharePoint creates unnecessary validation and compliance overhead. Many GxP systems remain invisible to senior leaders, introducing hidden risks and compliance gaps.
Quality and leadership teams lack global visibility into locally managed systems.
No Standardization
A patchwork of legacy practices across systems results in inconsistency and fragmented compliance.
This limits the ability to implement modern compliance strategies for cloud, AI, and emerging technologies.
Outdated Information
System metadata is often inaccurate or out of date. Ownership may be unclear, and audit responses can be delayed by missing or obsolete documentation.
Without reliable data, it’s nearly impossible to apply a cohesive, risk-based approach to compliance.
Regulatory Mandates
Regulators increasingly expect a comprehensive, validated inventory of GxP computerized systems — as outlined in FDA guidance and required under EU Annex 11.
Scrutiny of clinical systems and data integrity continues to grow, making oversight more critical than ever.
Why Choose Phanero?
Faster Return on Investment
Lean, risk-based approaches drive faster digital transformation — no more spreadsheet sprawl or manual effort.
Compliance Without Burden
Focus on your core business while we embed Annex 11 and 21 CFR Part 11 best practices into your workflows.
AI Enabled
Automate validation and risk classification with intelligent, AI-powered records and recommendations.
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Frequently Asked Questions
What types of systems can I track in Phanero?
Phanero is designed to manage a wide range of GxP-regulated computerized systems, including Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), Chromatography Data Systems (CDS), Programmable Logic Controllers (PLCs), and Enterprise Resource Planning (ERP) solutions.
How does Phanero ensure compliance with GxP regulations?
Phanero facilitates compliance with regulations such as 21 CFR Part 11, Annex 11, and GAMP 5 by providing a centralized inventory of computerized systems, tracking validation status, ownership, and system versions to ensure comprehensive oversight.
Is Phanero suitable for organizations of all sizes?
Yes, Phanero is scalable and can be tailored to meet the needs of both small teams and large enterprises within the life sciences sector.
Can Phanero integrate with our existing Quality Management System (QMS) and IT Service Management tools?
Phanero is designed to combine relevant data from your QMS and IT Service Management tools, providing a single source of truth for your computerized systems inventory.
How can I participate in the Phanero pilot program?
You can inquire about the pilot program by booking a demo below or by emailing phanero@erasciences.com.