Polarion ALM — implemented right,
validated right, governed right.
Compliance Group is a certified Siemens Technology Partner for Polarion Application Lifecycle Management. We implement, validate, and govern Polarion environments for medical device, pharmaceutical, and biotech organizations — with the team that co-authored the GAMP 5 Second Edition standard your validation is measured against. CLAiRE Nova Polarion Copilot embedded AI compliance intelligence integrated from day one.
Polarion is the most capable ALM in regulated life sciences.
Most organizations use 20% of it.
Polarion is the most capable ALM platform in regulated life sciences. It's also among the most under-utilized. Most organizations deploy a fraction of Polarion's capability — and validate none of it properly. The organizations getting real value from Polarion have a certified partner who understands both ALM and GxP. We're that partner — and CLAiRE Nova Polarion Copilot adds AI-powered compliance intelligence on top.
What your Polarion environment looks like under Compliance Group governance.
Your design control is defensible
Requirements traceable to tests, tests traceable to risk, risk traceable to design decisions. Every change control documented and linked. An inspector walks through your design history file in minutes, not weeks.
Validation is built in from the start
CSA-aligned validation from day one. Every configuration is validated against intended use, risk-based test protocols in place, and audit-ready documentation generated automatically via CLAiRE Nova.
Your ALM scales with your program
As your product portfolio grows, your Polarion environment scales with it. Templates, workflows, and integrations built to your standards — not retrofitted later. Managed services available post-go-live.
AI-powered compliance intelligence embedded
CLAiRE Nova Polarion Copilot embeds AI compliance intelligence directly inside Polarion — Smart Trace gap detection, AI quality check, regulatory knowledge base, and compliance dashboard. Data never leaves your server.
End-to-end Polarion governance — from implementation to continuous AI-powered compliance.
Polarion Design Control Implementation
ISO 13485 and 21 CFR Part 820-aligned design control in Polarion. Requirements management, risk management (ISO 14971), verification and validation traceability, design history file management, and change control governance. End-to-end traceability from design input to release.
CSA-Aligned Polarion Validation
Risk-based validation for Polarion ALM deployments. URS, configuration specification, IQ/OQ/PQ execution with proprietary templates, automated artifact generation via CLAiRE Nova, and audit-ready documentation. Validated state maintained through every upgrade and configuration change.
Polarion Center of Excellence
Ongoing governance: configuration management, user and role administration, integration maintenance, release upgrade support, periodic review readiness, and audit preparation. 40–60% below traditional rates. Zero major audit observations commitment with no-cost remediation.
AI compliance intelligence embedded inside Polarion.
CLAiRE Nova is an embedded AI copilot inside Polarion ALM — installed as a native plugin, no extra infrastructure required. AI chat, compliance dashboard, Smart Trace gap detection, AI quality check, and regulatory knowledge base. All data stays on your Polarion server.
Smart Trace Gap Detection
Automatically identifies traceability gaps between requirements, risks, tests, and design decisions. Surfaces broken links and missing coverage before an inspector does.
AI Quality Check
Reviews requirements for completeness, testability, and compliance alignment. Flags ambiguous language, missing acceptance criteria, and design control violations before they reach review.
Regulatory Knowledge Base
Embedded guidance from ISO 13485, 21 CFR Part 820, ISO 14971, IEC 62304, and GAMP 5 — answerable inside Polarion without switching context. Always current.
Data Never Leaves Your Server
CLAiRE Nova is installed directly on your Polarion instance. Zero external API calls for your regulated data. Full compliance with your data residency and security requirements.
Every Siemens Polarion engagement connects to CLAiRE AI Agentic Platform for Audit Trail Review, Continuous Monitoring, and Quality Reviews — and to iQuality for organizations building a complete QMS alongside their design control program. One partner. One governed stack.
Book a Free Assessment.
45 minutes with a certified Polarion and GxP expert. We review your current Polarion environment or planned deployment, identify validation and governance gaps, and recommend the fastest path to a defensible, inspection-ready state. Written brief included. No commitment.
Book a Free Assessment →