Siemens Polarion, Application Lifecycle Management

ACCELERATING INNOVATION WITH VALIDATED ALM SOLUTIONS

Services Partner

POLARION GOLD PARTNER

Compliance Group is your Siemens ALM Award- Winning Gold Partner, bringing you tailored governance, validation, and managed services to ensure compliance at scale. We design, validate, and scale digital product lifecycles on Polarion ALM.

FDA & Industry Leadership

Co-led workshops on Digital CSA & Agile Validation

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500+

Systems Validated using CSA and Polarion

2x siemens polarion expert partner

Siemens Polarion Partner
of the Year

Integrated Service Pillar

BUILT ON POLARION, ELEVATED BY CG

Product Software Development & Risk Management

  • Full SaMD/SiMD lifecycle in a single source of truth
  • Requirements → design → V&V → release with closed-loop traceability
  • Streamlined regulatory submissions and audit readiness

Design Control & RIsk Management

  • ISO 13485 / ISO 14971 aligned design-risk convergence in Polarion
  • Automated V&V traceability matrix and risk dashboards
  • Role-based reviews and approvals

Process Validation

  • Process Design, OQ, PQ, pFMEA, data capture, and evidence in context
  • Risk-based validation scaled from a single line to global networks

CSA / CSV Lifecycle

  • CSA first, CSV where needed—both governed in Polarion
  • Automated test strategy generation(clAIre) and documentless validation options
  • Pre-configured workflows and fulldocument/data traceability
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Equipment Qualification

  • Turnkey IQ/OQ/PQ in Polarion with integrated change control & calibration
  • Digital evidence chains aligned to audits and inspections

KEY FEATURES OF POLARION AND MENDIX

Rapid Deployment
Zero-footprint, web-based start, CG accelerators at go live in days
Ease of Use
Familiar Excel/Word round-trips, low training burden
Fast ROI
Lower TCO, higher compliance yield, reusable assets
Integration Ready
Out-of-the-box connectors: Veeva, JIRA, Mendix, Teamcenter, Jama
Scalable
Role-based architecture, multi-site/global deployments
Governance
Proven ALM governance + validation playbooks by CG
clAIre Inside
AI-generated tests, risk insights, and automated traceability

CENTERS FOR EXCELLENCE

SIEMENS, MENDIX, AND CG IN ACTION

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Let’s Accelerate Your Digital Product Journey

Whether launching your first SaMD product or scaling SiMD, Compliance Group provides the validated foundation for continuous innovation.

Hello, how can we help you?
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