See what a validation package looks like when it builds itself
A short walkthrough of how GxPForge keeps traceability current as your team works, instead of reconstructing it before a release.
Book a demoSoftware as a Medical Device, SaMD, is software that is itself the regulated product, not just a tool used to manufacture or test one. It shares data integrity and lifecycle discipline with computer system validation, but it answers to device regulation, not just internal quality processes.
A LIMS used inside your lab is a computerized system you validate for your own compliance. Software sold as a diagnostic aid, a risk calculator, or a clinical decision tool is a different animal, it is the product, and it goes through device level regulatory pathways, not just internal CSV.
An AI model built to flag anomalies in your own manufacturing data usually stays on the CSV side of the line, it is a tool you use internally. The same model, packaged and sold to another company as a diagnostic aid, crosses into SaMD territory. Some companies build internal tools that later get commercialized without anyone revisiting which side of that line the tool now sits on.
A short walkthrough of how GxPForge keeps traceability current as your team works, instead of reconstructing it before a release.
Book a demo