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Customizable document control solution for 3D printing at the point-of-care.
- Source :
- 3D Printing in Medicine; 3/17/2023, Vol. 9 Issue 1, p1-6, 6p
- Publication Year :
- 2023
-
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. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 23656271
- Volume :
- 9
- Issue :
- 1
- Database :
- Complementary Index
- Journal :
- 3D Printing in Medicine
- Publication Type :
- Academic Journal
- Accession number :
- 162508058
- Full Text :
- https://doi.org/10.1186/s41205-023-00172-0