Codebeamer Templates

Developing medical technology products? Use this template to manage your medical device software design and engineering processes for compliance with EU MDR and US FDA regulations and applicable standards: IEC 82304-1, IEC 62304, ISO 14971, and FDA 21 CFR Parts 11 & 820.

Take advantage of built-in MedTech development knowledge to adopt best practices with minimal effort. This template covers the development lifecycle of MedTech software from requirements all the way through to validation.

MedTech developers can use this template to ensure high-quality products, accelerate regulatory audits, control quality documents, manage forms and CAPA, and conduct root cause analysis all in one place:

• Adhere to regulatory requirements
• Simplify compliance assessments
• Comply with QMS regulations audits, including ISO 13485:2016 and FDA Title 21 CFR Part 820
• Maintain rigorous QC across the entire development lifecycle
• Manage deviations from established processes
• Report on quality activities to simplify audits

The Good Automated Manufacturing Practice® 5 (GAMP® 5) Template supports pharma project validation and quality risk management, ensuring high-quality products, minimum waste, and regulatory compliance.

Pharma companies, production device suppliers (automation technology and control systems), and system integrators all rely on GAMP® 5’s built-in documentation for applying computerized systems management best practices in the pharma environment to achieve compliance.

For automotive embedded systems developers, this template helps minimize the use of resources, cut audit preparation costs, and tackle regulatory compliance (ISO 26262:2018, ASPICE, CMMI, and other regulations).

The template comes with baked-in domain knowledge, automotive best practices, and compliant workflows right out of the box. Adjust built-in processes and reduce the time it takes for teams to define mature automotive systems engineering and development processes.

This Airborne Electronic Hardware Template comes preconfigured with aviation domain knowledge, predefined work items and processes, and best practices to support product delivery in accordance with aviation regulations:

• Develop safe, reliable, and high-quality airborne products, aviation software and hardware, and embedded avionics systems
• Implement mature processes
• Report on the entire avionics development lifecycle efficiently to simplify compliance audits
• Manage risks, development, and QA in a traceable manner

This ISO 9001:2015 QMS Template helps reduce time, effort, and costs of building and maintaining a thorough quality management system (QMS):

• Demonstrate quality standards maturity and ISO 9001:2015 compliance
• Document standard operating procedures with predefined artifacts and processes
• Track processes and enhance nonconformance visibility and management
• Ensure full change control with e-signatures for QMS integrity during improvement changes

This Scrum Template has been created to support teams working with the Agile framework using scrum or kanban. Manage and monitor Agile development and provide your teams with a powerful collaborative platform.

This template provides a great basis for any Agile project. Support your teams with preconfigured work items, advanced release and sprint management capabilities, and domain knowledge built into a collaborative workspace.

The Agile-Waterfall Hybrid Template helps to combine Waterfall/V-model, Agile, scaled Agile, and custom development processes in complex, multitier systems development. Maintain structure and integrity while giving teams more freedom:

• Ensure collaboration across hardware (Waterfall/V-model), software (Agile), systems, and service innovation teams
• Manage the entire development lifecycle from a single central platform
• Adhere to defined overall systems engineering plans
• Enable teams to adapt to changing requirements with flexibility