Who needs SMC
FDA 21 CFR Part 11 requires electronic records and audit trails for manufacturing processes. CNC programs are electronic records. Most shops can't prove it.
Who this is for
Medical device manufacturers and contract machine shops that produce components for regulated medical devices. These shops must demonstrate traceability from drawing to G-code to machine under FDA 21 CFR Part 11.
The challenge
FDA 21 CFR Part 11 requires audit trails for electronic records that affect the manufacture of medical devices
CNC programs that produce device components are electronic records
No traceability from CAM programming to finished part
FDA 483 observations for inadequate manufacturing controls are increasing
Program changes are not tracked — a wrong revision produces a nonconforming part
"FDA audited us and cited our lack of CNC program version control."
"We had a nonconformance because the wrong revision was on the machine."
"We need to prove traceability from the drawing to the G-code to the machine."
How SMC helps
Every program revision is stored in an encrypted vault with SHA-256 hash verification. You know exactly which revision ran on which machine.
When a program is modified at the machine, SMC generates a line-by-line diff for supervisor review and approval before the change is accepted into the vault. Every approval is a timestamped, tamper-evident record.
Every transfer, revision, approval, and rejection is logged automatically — providing the electronic records FDA requires without manual documentation effort.
Destructive or irreversible actions require re-authentication, creating a tamper-evident approval chain that satisfies 21 CFR Part 11 electronic signature requirements.
See how SMC provides version control, change management, and the electronic records FDA requires.