Table 1 Features for our 3D printing DCS.
From: Customizable document control solution for 3D printing at the point-of-care
Required features | Desired features |
|---|---|
Document control (versioning, archiving, etc.) | Structure and templates designed for medical device development |
Electronic signoffs/approvals with CFR Part 11 compliance | Connectivity between documents (live links to referenced documents) |
Ability to store overarching standard operating procedures, work instructions, records, etc. related to program’s infrastructure/policies (Word documents, Excel spreadsheets) | Design history file (DHF) creation |
Ability to sort standard operating procedures, work instructions, records, etc. by project (Word documents, Excel spreadsheets) | Complaint management |
Creation of FDA-compliant audit documents | Change order management |
Corrective and preventative action (CAPA) subsystem | |
Management of employee training | |
Consulting services (related to CFR Part 820) | |
Risk management capabilities |