Rommana ALM was designed to support and enforce many standards and processes required by IEC 62304,
IEC 60601, ISO 14971 and other ISO/IEC/FDA standards. Rommana ALM for medical devices suports the following features:
Enforces complete and detailed product requirements for all types of requirements including hardware,
firmware, software, quality, performance, safety, and usability. All requirements are treated seamlessly.
Allows defining implementation actions for safety, performance, and usability requirements and tracks
those actions throughout the development process
Provides complete traceability of all requirements to code modules and design components
Allows the enforcement of e-Signature on reviewing, approving, and editing project entities
Allows for defining and maintaining Failure Mode and Effect Analysis (FMEA)
Provides complete traceability of all requirements to test scenarios, test cases and test sets
The Requirement/Test Coverage matrix guarantees that every requirement had the adequate number of
test cases and it shows the readiness of the feature for release as well as remaining tests
Allows for defining the dependencies between different requirements
Allows all team members and customers to collaborate on reviewing requirements and suggesting changes
and adjustments to the requirements
All changes to any requirement are tracked through the history of a requirement
Allows for defining workflow to assign approval authority for all requirement and all change requests to
the requirement and tracks the approval process
The Change Management component of Rommana ALM tracks major changes to requirements and the
impact of these changes
The Change Management Component also maintains multiple versions of a requirement based on changes
Risk Management: All risks associated with any requirement are tracked throughout the development process
All tasks associated with the implementation of a requirement are assigned to resources and progress is
tracked throughout the development process and beyond
The Document management component of Rommana ALM provides a platform for complete documents
required by all IEC, ISO, and FDA standards