For regulated product companies, audits are inevitable. Whether you’re developing medical devices, high-tech electronics, or aerospace and defense systems, there’s a regulation you must comply with. Teams are expected to meet multiple standards, including FDA, ISO, EU MDR, ITAR/EAR, and environmental requirements. But if you’re relying on spreadsheets or paper processes, this can cause real anxiety when preparing for an audit. Internal compliance teams often struggle to gather evidence that is spread across systems, processes are hard to track and prove, and audits interrupt real work. Audit readiness is reactive, and risk increases.
Prepare for industry audits with connected product and quality processes. Arena helps teams maintain traceability, document control, training records, and change history in a single cloud-native system.
—Richard Rushton, Quality Environmental Health and Safety Manager
Disconnected systems, manual approvals, and spreadsheet-based tracking make audits harder to manage and increase compliance risk.
Manufacturers can decrease audit risk by automating processes and connecting product and quality records in a single connected product lifecycle management (PLM) and quality management system (QMS) solution.
Every action is captured, linked, and time-stamped, creating a clear, traceable record across the product lifecycle.
Audit ready teams build compliance into daily operations by:
Arena connects PLM and QMS records and processes to help regulated teams improve visibility, reduce documentation gaps, and simplify audit preparation.
Disconnected systems, manual approvals, and spreadsheet-based tracking make audits harder to manage and increase compliance risk.
Manufacturers can decrease audit risk by automating processes and connecting product and quality records in a single connected product lifecycle management (PLM) and quality management system (QMS) solution.
Every action is captured, linked, and time-stamped, creating a clear, traceable record across the product lifecycle.
Audit ready teams build compliance into daily operations by:
Arena connects PLM and QMS records and processes to help regulated teams improve visibility, reduce documentation gaps, and simplify audit preparation.
With Arena’s connected PLM and QMS solution, regulated manufacturers can support compliance efforts without slowing product development. Arena helps teams maintain end-to-end traceability, strengthen document control, improve training visibility, and manage changes more consistently across the product lifecycle. This supports initiatives related to FDA 21 CFR Part 11, FDA 21 CFR Part 820, ISO 13485, ISO 9001, AS9100, and EU MDR while helping teams stay aligned, audit-ready, and prepared for evolving requirements.
For companies managing environmental and material compliance obligations, Arena also provides centralized component compliance information management. Teams can track supplier declarations, monitor restricted substances, and maintain supporting documentation for regulations including RoHS, REACH, WEEE, Conflict Minerals, and Proposition 65. By connecting product, quality, and supplier data in one system, Arena helps reduce manual effort, improve visibility, and support faster, more informed compliance decisions.
Medical device companies benefit from Arena's audit ready QMS.
Arena QMS helps medical device companies meet and maintain ISO 13845, FDA 21 CFR Part 820, and EU MDR quality management system (QMS) compliance.
With a product-centric approach to quality, Arena helps medical device companies gain control of DMR, DHF, SOPs, training records, and adhere to the FDA 21 CFR Part 11 requirements for electronic signatures.
Aerospace and defense companies benefit from Arena's audit ready PLM for Government.
Arena PLM for Government is hosted on AWS GovCloud to help aerospace and defense and government contractors meet strict security and export controls required for CMMC and ITAR/EAR compliance. Arena's connected quality management system enables complete traceability and closed-loop processes for AS9100 compliance.
High tech electronics companies benefit from Arena's audit ready PLM and QMS solutions.
Arena PLM and QMS provide a single source of truth for internal product teams and external partners to efficiently manage product record information and associated environmental evidence.
Arena PLM and QMS helps high tech electronics companies meet ISO 9001 and environmental standards including RoHS, REACH, WEEE, conflict minerals, and Proposition 65.
Connected cloud-native PLM and QMS solutions turn audit readiness into day-to-day execution.
See status, ownership, and progress across product and quality processes
Link requirements, changes, approvals, and quality events (CAPAs) to the full product record/bill of material (BOM)
Maintain revision control, so teams always work from accurate, up-to-date information
Learn how Arena customers build audit readiness into daily operations so audits become easier, faster, and less disruptive.
Learn how to integrate compliance processes into your daily operations.
Learn how to integrate compliance processes into your daily operations.
Automating processes and adopting solutions that define a single source of truth for teams to maintain traceability, control changes, and keep audit evidence up to date.
Cloud-native, connected PLM and QMS software helps manage product and quality records in a single system for faster evidence retrieval and easier audits.
Using spreadsheets creates silos of information, making it harder to track and control product and documentation revisions, and confidently produce accurate audit evidence.
Arena PLM and QMS can support compliance with FDA, ISO, EU MDR, RoHS, REACH, and similar QMS and environmental requirements. Arena PLM for AWS GovCloud supports customers who need to comply with ITAR/EAR, CMMC, and/or AS9100.
Automating processes and adopting solutions that define a single source of truth for teams to maintain traceability, control changes, and keep audit evidence up to date.
Cloud-native, connected PLM and QMS software helps manage product and quality records in a single system for faster evidence retrieval and easier audits.
Using spreadsheets creates silos of information, making it harder to track and control product and documentation revisions, and confidently produce accurate audit evidence.
Arena PLM and QMS can support compliance with FDA, ISO, EU MDR, RoHS, REACH, and similar QMS and environmental requirements. Arena PLM for AWS GovCloud supports customers who need to comply with ITAR/EAR, CMMC, and/or AS9100.
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