Compliance Management

Arena helps you manage compliance by centralizing all of your product information including compliance data and documentation. Track part compliance status, conformance evidence and material composition in a revision-controlled environment from design through end-of-life.

By using Arena you’ll achieve—and prove—compliance with the following standards and regulations:

Medical Device

Arena enables compliance with FDA 21 CFR Part 11 (Electronic records and signatures), 21 CFR Part 820 (Quality system regulation) and ISO 13485 (Quality management systems). Because Arena is delivered as Software as a Service (SaaS), validation documentation is provided by Arena with every release, saving you time and money on burdensome Installation and Operation Qualification (IQ and OQ) processes. Learn how Arena can help you meet FDA and ISO regulations for medical devices.

Environmental

Arena enables you to track product compliance for environmental requirements like RoHS and WEEE. Learn how Arena can help you attain RoHS compliance.

Product Safety

Easily track product safety standards and certification in Arena.

Arena enables you to efficiently and accurately track standards and certificates of compliance including UL, CE, CCC, FCC, VCCI, CDA and others. Arena provides dedicated BOM views for compliance and reporting capabilities to enable consistent conformity assessments. Engineering change management capabilities ensure that compliance can be maintained throughout a product’s lifecycle. Download Arena Compliance Management Datasheet.

Process

Meet ISO 9001 requirements with Arena.

Arena provides document control capabilities, enabling companies to meet ISO9001:2000 requirements. Bills of materials (BOMs) and individual files can be managed under revision control with appropriate approvals and notifications. Download Arena Compliance Management Datasheet.