Customizable document control solution for 3D printing at the point-of-care.

Abstract

Background: The rapid expansion and anticipated U.S Food and Drug Administration regulation of 3D printing at the point-of-care necessitates the creation of robust quality management systems. A critical component of any quality management system is a document control system for the organization, tracking, signature collection, and distribution of manufacturing documentation. While off-the-shelf solutions for document control exist, external programs are costly and come with network security concerns. Here, we present our internally developed, cost-effective solution for an electronic document control system for 3D printing at the point-of-care.

Methods: We created a hybrid document control system by linking two commercially available platforms, Microsoft SharePoint and Adobe Sign, using a customized document approval workflow.

Results: Our platform meets all Code of Federal Regulations Title 21, Part 11 guidances.

Conclusion: Our hybrid solution for document control provides an affordable system for users to sort, manage, store, edit, and sign documents. The system can serve as a framework for other 3D printing programs to prepare for future U.S Food and Drug Administration regulation, improve the efficiency of 3D printing at the point-of-care, and enhance the quality of work produced by their respective program.