If you make electronic devices for medical use, your records fall under US FDA Title 21 CFR Part 11. It sets the conditions under which electronic records count as the legal equivalent of paper, and it is strict.
A compliant electronic record-keeping system has to provide:
Part 11 also expects lot tracking, with traceability in both directions:
PartsBox gives you the record-keeping that Part 11 is built on. The audit trail is immutable and signed on export. Every user is a distinct, personal account, with role-based access control limiting each one to the operations their role allows, and password handling can follow NIST SP 800-63B AAL1 rules. Lot control and serial numbers give you forward and backward traceability down to the individual device. Even an early prototype is built with full traceability — which is exactly when a medical-device startup tends to assume it does not matter yet, and it does.
The same record-keeping serves beyond medical work. Defense, aerospace, and space contracts write similar expectations — controlled access, an unalterable change record, lot-level traceability — into their quality clauses, and they are met by the same features.
Compliance is ultimately about your process, not only your software: you still validate the system for your own use and operate it correctly. What PartsBox does is provide the secure records, audit trail, electronic signatures, and lot traceability that make that achievable without building the system yourself.
These capabilities are on the Compliance plan.