Medical Requirements Management
Intland’s Medical IEC 62304 & ISO 14971 Template comes with preconfigured medical requirements trackers to enable you to specify, collaborate on, and document your requirements. These artifacts may be further customized, letting you manage both initial and changing requirements, with all changes being automatically logged and displayed on each work item. codeBeamer’s integrated architecture & single repository allow you to conveniently establish links between requirements, source code and test cases as well as regulatory documents. The Traceability Browser lets you simply visualize links between artifacts, and easily pull & export traceability reports for compliance audits.
Medical Software Development & Release Management
Software development features are integrated in the ALM functionality, so end-to-end traceability between requirements or user stories, tasks, source code, test cases and releases is ensured. codeBeamer’s release management functionality allows you to plan activities, iterations and releases (milestones, versions), with time and effort estimates added. Statistics and Gantt charts help you monitor the progress of all development streams. Waterfall, Agile, Hybrid, and scaled Agile (via SAFe®) development methods may be applied or combined even within a single project.
Security and Approval Workflows with e-signatures
codeBeamer’s advanced workflow engine lets you define and enforce complex workflows with role or member-based access control, and guards with (FDA compliant) e-signatures for approval management. To prove that process enforcement has been ensured during development, the visualized workflow can be exported conveniently. The complete change history on all work items also logs signatures and approval data (timestamp, member, action) in human readable format.
Medical Risk Management
Risk management is supported by predefined, but flexibly configurable medical risk trackers. These trackers can store all risk-relevant data such as severity, likelihood, current risk controls, planned mitigation actions, etc. Links between risks and requirements may be established, and the overall risk level visualized using highly configurable Risk Matrix Diagrams. After risk prioritization, requirements can be derived from risks, and assigned to team members, with complete traceability maintained.
Failure Mode and Effects Analysis
To further support your hazard management efforts, a preconfigured Failure Mode and Effects Analysis (FMEA) feature set is available in codeBeamer ALM, and may be used out of the box with no further configuration necessary (but possible). It allows you to identify, define, and control the mitigation of risks, while ensuring traceability between requirements, failure modes, and test cases. Risk Matrix Diagrams visualize your overall risk levels, and Risk Priority Numbers are calculated automatically. codeBeamer’s FMEA functionality comes with a comprehensive guide to conducting Failure Mode and Effects Analysis, and offers a complete FMEA Worksheet that may be exported in several formats.
Medical Quality Assurance & Testing
codeBeamer’s QA & Testing functionality lets you define test cases (which may be simply generated from requirements), organize them into test sets, save them in test libraries for later re-use, execute test runs on multiple hardware and software configurations manually or automatically, and conveniently report bugs. Parameterized testing is supported. Due to codeBeamer’s complete integration and end-to-end traceability, requirements-based testing is supported, and a Test Coverage Browser is available to visualize the coverage of requirements with test cases. Automated testing can be executed via codeBeamer’s integration with Jenkins.
Medical Wiki, Document Management
The medical wiki fully supports compliance with IEC 62304 as its contents cover the standard’s requirements, provide users with domain knowledge, and support the application of rules throughout the entire development lifecycle. codeBeamer’s Documents tracker satisfies the requirements of ISO 9001:2008 and can be used to store and manage all documents (with a complete version history, and full text search), providing your teams with a single source of truth, and facilitating compliance audits.
Using baselines, you can create lightweight snapshots of the current state of all your artifacts. All details of your work items including wiki pages, documents, images, attachments, comments etc. can be saved in baselines that may be compared or browsed any time. This is the primary means for versioning the states of rapidly changing requirement specifications along the process of their evolution.
About Intland Software
Intland Software help you make your software better, faster and higher quality with better processes and tools by helping you manage your software application lifecycle from Demand, Requirements, Development and Test to Delivery. More details…
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