Compliance

Compliance with confidence.

Manufacturers today must comply with an increasing number of standards and regulations. These can range from product-related standards for safety, EMC/EMI, interoperability and environmental requirements to quality management system standards like ISO9001. But, whether required by customers or by law, compliance has become critical to maintaining competitive position-and sometimes even to staying in business.

Free Datasheet Download

Arena Compliance Management

Learn how we can help you solve compliance issues. With Arena you can quickly and easily attain compliance with environmental, industry and safety regulations.
Download the datasheet

With the new WEEE and RoHS regulations introduced by the European Union, many manufacturers realize they need a mechanism to track part-level compliance status and evidence. They also need instant reporting to minimize the risk of shipments being held at a border. For manufacturers who need to track individual material substances this quickly turns into a large volume of information that often must be tracked in addition to test plans, test reports and certificates for various safety and EMC/EMI-related product standards (e.g., CE, CCC). This makes efficient and accurate documentation management essential.

Arena supports product compliance management by:

enabling manufacturers to efficiently manage requirements and compliance data,
supporting design for compliance initiatives,
performing accurate and consistent conformity assessments,
reducing supply chain transition risks, and
providing instant compliance reporting.

In addition, manufacturers can leverage Arena to achieve compliance with quality management system standards and regulations like ISO9001 and the FDA’s QSR/cGMP.

Environmental Regulation Compliance

The WEEE and RoHS regulations require manufacturers to track part-level materials data and document compliance even years after product release and subsequent redesign(s). To self-declare compliance or at least demonstrate due diligence, manufacturers need thorough product data and compliance management tools like Arena. For manufacturers to avoid weeks of shipment delays, these tools must respond instantly with a complete, accurate and understandable compliance report…read more

Safety Standards Compliance

Most of the safety standards for markings like UL, CE, and CCC require strict design considerations as well as detailed documentation in order to obtain certification.

The Arena compliance management solution increases the efficiency and accuracy with which standards and certifications for critical components can be tracked. For example, entire commodity groups like power supplies can be categorized to automatically carry related safety standards as a requirement. In addition, the powerful Compliance BOM and reporting capabilities in Arena enable consistent conformity assessments, and engineering change management capabilities ensure compliance can be maintained throughout a product’s entire lifecycle.

Industry Standards Compliance

For certification and qualification of products with certain industry standards, manufacturers may either go through a self-certification process or use third-party certification. For example, for DOCSIS compliance, a manufacturer has to complete a conformance checklist, complete a CableLabs’ test suite for DOCSIS compliance and submit an affidavit of DOCSIS conformance. Arena customers use the compliance management capabilities in Arena to track sub-system configurations and associate revision-specific certification and qualification documentation.

ISO9001 Compliance

Arena provides comprehensive document control capabilities, enabling customers to meet ISO9001:2000 requirements. Both product records (BOMs) and individual files can be /file-management.htmlmanaged under revision control with appropriate approvals and notifications. The on-demand Arena delivery model allows for worldwide access without any IT investment. Multiple Arena customers have passed their annual ISO9001 audits using Arena to demonstrate the necessary document controls.

FDA QSR/cGMP & Part 11 Compliance

Arena is used by medical device manufacturers (from class I to III, including small start-ups and large public companies) to manage their Device Master Record and Design History File as part of their Quality Management System in compliance with the QSR/cGMP regulations. For example, customers directly benefit by leveraging best practices around document numbering and change management. Arena also provides a complete and proven IQ/OPQ validation kit to support FDA-regulated customers to meet Part 11 requirements [21 CFR Part 11.10(a)] for system validation. The Arena solution has been audited by FDA inspectors during audits of our clients—and they have successfully passed.

ISO13485 Compliance

Medical device manufacturers selling products in Europe require ISO13485 compliance. Similar to its usage for compliance with QSR/cGMP, Arena is used by various companies to meet ISO13485 requirements. Several of those customers have successfully passed audits by TÜV, BSI and other auditors.