codebeamer X is an Engineering Lifecycle Management (ELM) platform for the development of software-driven products. For life sciences companies, it extends ALM functionalities with regulatory process templates, quality management, and review boards. All this in a single, tightly integrated platform that you can easily configure for your processes.
Integrated product delivery
Align the design and development processes of medical device hardware, software, and service components. Manage the impact of changes across the lifecycle. Give your teams a platform to collaborate efficiently, channel feedback into design decisions, and maintain focus on quality as delivery accelerates.
Full risk management & audit support
Gain confidence in asserting compliance with medical device regulations. Guarantee the early and adequate management of risks, and execute FMEA conveniently. Achieve transparency, traceability, and accurate documentation along product delivery. Manage approvals, export custom audit reports, and simplify design and product verification and validation.
Agility in regulated development
Provide freedom for your teams, and confidence for your auditors. Enforce the use of controlled processes to enable Agility in full adherence to medical regulatory requirements. Accelerate the delivery of medical technology, and assert compliance with minimal effort.
Define, manage, change, and review requirements with full traceability across the development lifecycle. Collaborate with stakeholders throughout development with requirements sharing, comparing, reviewing, and approval.
Build safe and reliable products, and comply with relevant MedTech regulations with ease.
Define, plan, manage, automate, and track MedTech product testing while providing full traceability. Track requirements’ test coverage and monitor tests-requirements consistency.
Agile Project Management:
Plan, track and manage the Agile development of medical devices without jeopardizing compliance. Use the Release Planner, Kanban board, custom dashboards, backlog and release management functions to stay organized. Maintain transparency, full traceability, and automatically logged audit trails throughout the lifecycle.
Automate daily tasks with rules and triggered actions. Choose from preconfigured workflows, or design your own.
Keep your teams connected and the work aligned across the organization. Ensure transparency in collaboration without slowing down processes. Loop in both internal and external stakeholders. Manage changes, versions, baselines and approvals transparently in one shared digital workspace.
Document Lifecycle Management:
Eliminate paper-based processes. Go digital with an automated & collaborative platform for storing, sharing, and managing your documents and files.
Reporting, Analytics and Dashboards:
Provide real-time insights with dashboards and build automated reports for clarity and transparency. Measure, improve, and predict your team’s performance.
Integration & DevOps
Connect your fragmented tool environment in a central development platform through out-of-the-box integrations. Reduce hidden costs and the tedious manual work of creating integrations. Enjoy full traceability and data consistency, and slash tool maintenance costs.