Normally achieving compliance with standards like IEC 62304 and FDA 21 CFR Part 11 and FDA General Principles of Software Validation would require sorting through mountains of documentation and acquiring costly point solutions. Our ALM saves you from all this by providing a simple solution to manage the entire lifecycle of your medical device software development.
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Get accurate traceability for all artifacts throughout the entire lifecycle. Our solution offers bi-directional traceability from requirements all the way to testing or vice versa. Development teams have the freedom to use any development methodology while linking to requirements and testing.
Automate routing, approval or escalation to ensure standards are always followed. Substitute paperwork and handwritten signatures with electronic records and electronic signatures to quickly achieve compliance.
Get started quickly using out-of-the-box templates and workflows and intuitively customize them to reflect unique company processes. Implement repeatable processes that can always be analyzed and improved upon.
AUDIT PROOF DOCUMENTATION
Create documentation with a single clock, without having to check references manually for hours. Audit trails are secured and time-stamped on any change.
Multisite capabilities offer the speed of a locally installed server to all teams. Teams no longer need to wait for results from remote teams since all data is in real-time and synchronized across all sites and flexible security controls can be implemented at all levels to limit visibility.
All documentation are stored in a secured single location. Eliminate the need to hunt down paperwork and reuse documentation at any time. Access controls at every level prevent unauthroized access.