Lohss Maxwell, Hammersley Elliott, Ghodadra Anish
University of Pittsburgh School of Medicine, 3550 Terrace St, Pittsburgh, PA, 15213, USA.
UPMC Department of Radiology, 200 Lothrop St, Pittsburgh, PA, 15213, USA.
3D Print Med. 2023 Mar 17;9(1):5. doi: 10.1186/s41205-023-00172-0.
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.
We created a hybrid document control system by linking two commercially available platforms, Microsoft SharePoint and Adobe Sign, using a customized document approval workflow.
Our platform meets all Code of Federal Regulations Title 21, Part 11 guidances.
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.
3D打印在即时医疗点的迅速扩张以及美国食品药品监督管理局即将出台的相关规定，使得建立强大的质量管理体系成为必要。任何质量管理体系的一个关键组成部分是针对组织的文件控制系统，用于跟踪、收集签名以及制造文件的分发。虽然存在现成的文件控制解决方案，但外部程序成本高昂且存在网络安全问题。在此，我们展示我们内部开发的、具有成本效益的即时医疗点3D打印电子文件控制系统解决方案。
我们通过使用定制的文件审批工作流程，将两个商用平台——微软SharePoint和Adobe Sign链接起来，创建了一个混合文件控制系统。
我们的平台符合所有联邦法规第21篇第11部分的指导原则。
我们的文件控制混合解决方案为用户提供了一个经济实惠的系统，用于对文件进行分类、管理、存储、编辑和签名。该系统可作为其他3D打印项目的框架，以应对未来美国食品药品监督管理局的规定，提高即时医疗点3D打印的效率，并提升各自项目所产生工作的质量。
