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

Maxwell Lohss1, Elliott Hammersley2, Anish Ghodadra3,4

  • 1University of Pittsburgh School of Medicine, 3550 Terrace St, Pittsburgh, PA, 15213, USA.

3D Printing in Medicine
|March 17, 2023
PubMed
Summary

We developed an affordable electronic document control system for 3D printing at the point-of-care. This system helps manage manufacturing documents and prepares programs for U.S. Food and Drug Administration regulation.

Keywords:
3D printingAdditive manufacturingCFR Part 11Document controlQuality controlQuality management systemRegulatory

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Area of Science:

  • 3D Printing
  • Quality Management Systems
  • Regulatory Compliance

Background:

  • The growth of 3D printing at the point-of-care requires robust quality management systems.
  • Document control is essential for tracking and managing manufacturing documentation.
  • Existing solutions are expensive and pose network security risks.

Purpose of the Study:

  • To present an internally developed, cost-effective electronic document control system.
  • To address the need for a secure and affordable solution for 3D printing quality management.

Main Methods:

  • A hybrid document control system was created by integrating Microsoft SharePoint and Adobe Sign.
  • A customized document approval workflow was implemented to link the platforms.

Main Results:

  • The developed platform complies with Code of Federal Regulations Title 21, Part 11.
  • The system provides a comprehensive solution for document management.

Conclusions:

  • The hybrid system offers an affordable solution for sorting, managing, storing, editing, and signing documents.
  • This framework can assist 3D printing programs in preparing for FDA regulations and improving efficiency and quality.