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

Customizable document control solution for 3D printing at the point-of-care 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. Keywords 3D printing, Additive manufacturing, Quality management system, Quality control, Document control, Regulatory, CFR Part 11 Introduction testing, creating new opportunities for surgical planning, Point-of-care 3D printing is a growing sector of health- decreasing time spent in the operating room, reducing care, currently being practiced across various academic medical errors, and ultimately improving patient care medical centers and private clinics [1]. Healthcare sys- and satisfaction [3–5]. tems have adopted 3D printing technologies to create As 3D printing expands into more clinical settings patient-specific anatomic models, surgical guides, and and broadens in its applications, the demand for robust other custom medical devices [2]. The use of 3D print - quality control grows. Most 3D printing programs can ing in the clinical environment is improving diagnostic be divided into three categories. Programs are either (1) developed in collaboration with a separate manufactur- ing company, (2) established internally under a hospital *Correspondence: department, or (3) developed as combination of both Anish Ghodadra external and internal manufacturing facilities [6]. These ghodadraa@upmc.edu UPMC Department of Radiology, 200 Lothrop St, Pittsburgh, PA different implementation strategies, as well as advance - 15213, USA ments in 3D printing technology, have made 3D printing University of Pittsburgh School of Medicine, 3550 Terrace St, Pittsburgh, more accessible for both large and small institutions. To PA 15213, USA © The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Lohss et al. 3D Printing in Medicine (2023) 9:5 Page 2 of 6 ensure that this rapid growth of 3D printing in healthcare concerns. To overcome these challenges, we present our settings continues to be safe and effective, robust quality internally developed, cost-effective solution for an elec - management infrastructure is critical [7–10]. With the tronic DCS for 3D printing at the point-of-care. U.S. Food and Drug Administration (FDA) releasing a In anticipation of FDA regulation of 3D printing and discussion paper on regulation of 3D printing in 2021, it to ensure that our printed parts are of the highest qual- is only a matter of time until formal regulation is placed ity, our 3D printing team created an FDA-compliant on 3D printing programs. As hinted by the FDA, this DCS that provides a cheaper, tailored alternative to tra- regulation could be as stringent as that of a traditional ditional solutions. We developed a hybrid system that medical device manufacturer [6]. The discussion paper uses an existing document management program to cre- also states that 3D printing entities should understand ate an internally managed DCS. Our solution provides a the existing requirements for medical device regulation streamlined workflow that can be easily implemented and and comply to the Quality System Regulation under Title modified. Our system is also capable of supplying docu - 21 Code of Federal Regulations (CFR) Part 820 (21 CFR ment templates, tracking version history, and collecting Part 820). This document was released by the FDA in electronic signatures, all while automatically generating 1978 to establish regulatory requirements for the meth- an FDA-compliant audit trail. The hybrid document con - ods, facilities, and controls used to produce medical trol platform can be easily implemented at a low cost by devices [11]. To meet 21 CFR Part 820 compliance, the any 3D printing team in a clinical environment, prepar- FDA requires the establishment of a quality management ing this new sector of healthcare for FDA regulation. system (QMS). A QMS functions as a formalized method for documenting processes, procedures, and respon- Methods sibilities to ensure that medical devices meet specified Document control system requirements for 3D printing requirements. Within the QMS, the FDA requires the Before developing our document control system, we out- use of a document control system (DCS) that is compli- lined system requirements based on existing guidance. ant with CFR Part 11, the FDA guidelines for electronic Requirements were developed according to 21 CFR Part record collection [12]. A DCS is a formalized process for 820 and CFR Part 11. We divided requirements into two the organization, tracking, signature collection, and dis- categories. The first category contains required features. tribution of manufacturing documentation. While off- These are features that are necessary for FDA compliance the-shelf solutions for a DCS exist, these are often costly and overall quality assurance. The second category con - and require use of Software as a Service systems which tains additional desired features which are nonessential. hospitals are hesitant to adopt due to network security Rather, these are features that make the platform easier to use, further streamline the workflow, and expand the Table 1 Features for our 3D printing DCS. system’s applications. These requirements are described Required features Desired features below in Table 1. Document control (versioning, archiving, etc.) Structure and templates designed for medical Evaluation of existing software applications device development After outlining system requirements, we evaluated exist- Electronic signoffs/approvals with CFR Part 11 Connectivity between ing software applications. The applications we explored compliance documents (live links to referenced documents) included Greenlight Guru (Greenlight Guru, IN, USA), Ability to store overarching standard operat- Design history file Qualio (Qualio, CA, USA), Solidworks PDM (SolidWorks ing procedures, work instructions, records, (DHF) creation Corporation, MA, USA), Compass (Cognition Corpora- etc. related to program’s infrastructure/poli- tion, MA, USA), MasterControl (MasterControl, Inc., cies ( Word documents, Excel spreadsheets) UT, USA), ETQ (Hexagon AB, Stockholm, Sweden), Ability to sort standard operating procedures, Complaint Arena (PTC, Inc., MA, USA), Qualtrax (Ideagen PLC, work instructions, records, etc. by project management ( Word documents, Excel spreadsheets) Nottingham, United Kingdom), and TrackWise (Sparta Creation of FDA-compliant audit documents Change order Systems, Inc., NJ, USA). Many of these applications have management well-designed user interfaces and technical capabilities Corrective and preven- to meet all required and desired features. Unfortunately, tative action (CAPA) these programs are expensive with costs significantly subsystem increasing as the number of dedicated users increases. Management of em- Additionally, security concerns pose a significant chal - ployee training lenge when working with external software platforms. Consulting services Patient information must be protected, and hospital soft- (related to CFR Part 820) ware security standards must be followed. Risk management capabilities Lohss et al. 3D Printing in Medicine (2023) 9:5 Page 3 of 6 Customized internal systems, on the other hand, can be in a Review Queue where users can see who has seen, designed to create individualized document control solu- approved, or rejected various documents. tions with an internal support team and acceptable secu- Our document control platform is structured in six rity protocols. The downside is that creating a completely sections, demonstrated in Fig.  1. Within Fig.  1, each custom DCS takes a significant amount of time and can section is labeled by a red box as either a SharePoint be significantly expensive. library, Power Automate program, or an Adobe Sign signature collector. The blue boxes summarize the Creation of a hybrid document control system function of a particular section. Yellow arrows rep- Our proposed solution is a hybrid document control resent the movement of a document from section to system. We have linked two commercially available plat- section. forms, Microsoft SharePoint (Microsoft Corporation, The first section, Controlled Documents, is where a WA, USA) and Adobe Sign (Adobe, CA, USA), using a user selects a template for document creation. Within customized workflow which allows for robust document this section, a user can edit the new document, select management. a hierarchy of reviewers, and send the document for We adapted SharePoint, a Microsoft product for shar- review. After sending the document for review, the ing and editing documents, along with Adobe Sign, a Part Agreement Creator is initiated. This section is a Power 11-compliant electronic signature collection service, to Automate program that creates an iterated version create a traceable DCS. The two platforms are connected of the document for review and combines it with an by Microsoft Power Automate, a programming applica- Adobe Sign template. This combination of document tion that allows for the development of automated work- and template are referred to as an “Agreement” within flows between various Microsoft and non-Microsoft Adobe Sign. platforms. With this automation, a document created The Adobe Sign agreement is then funneled to the in SharePoint can be assigned to reviewers and submit- Agreement Tracker. The Agreement Tracker is a sepa- ted for review and electronic signatures. The program rate Power Automate program that tracks the status of automatically sends the document to assigned reviewers an agreement within Adobe Sign’s Signature Collector and collects signatures via Adobe Sign. During the entire and reflects status changes to users via a SharePoint list process, documents are actively versioned and stored called Review Queue. The Signature Collector is housed within Adobe Sign to collect signatures and create an Fig. 1 Schematic diagram of our hybrid DCS. Lohss et al. 3D Printing in Medicine (2023) 9:5 Page 4 of 6 audit trail. Reviewers can perform three major actions; Results they can accept, reject, or cancel the agreement. If the For a DCS to be FDA compliant, it must meet the guid- reviewer performs any of these three actions, an update ances of CFR Part 11 for electronic signature collection is sent to the Agreement Tracker section which is further and document protection. Within our system, we use reflected in the Review Queue. Rejecting or canceling the Adobe Sign which is already considered Part 11 com- agreement automatically sends the document back to pliant as a legally binding signature collection platform. the document creator with comments and edits from the Table 2 outlines all CFR Part 11 subsections and specifies reviewer. If an agreement has been reviewed, accepted, how our system meets each guideline. and signed by all parties, the Agreement Tracker converts Section  11.30 of Part 11 is not considered because we the Agreement to a PDF document, attaches the audit operate within a closed system, internal to UPMC. All trail generated by Adobe Sign, and saves the document other sections were carefully examined when creating to the final section of the software, the Live Documents our platform. library. Documents in the Live Documents library are considered official published records and can be viewed Discussion by all users. Our hybrid DCS provides an affordable, customizable option for point-of-care 3D printing groups. Using a hybrid approach, we leverage the advantages of both existing software platforms and customized workflows. Table 2 CFR part 11 guidances and how our DCS accounts for each subsection CFR Part 11 Subsection guideline How our system meets guideline subsection 11.10 (a) Validation of systems Performance qualification document generated with FDA audit trail 11.10 (b) Generation of accurate and com- Documents are stored as Microsoft Word documents and PDF files plete digital and physical copies of records 11.10 (c) Protection of records SharePoint-managed groups and permissions with account passwords 11.10 (d) Access limitations SharePoint-managed groups and Microsoft account passwords Individual documents can be further password protected if necessary 11.10 (e) Creation of time-stamped audit SharePoint tracks all changes to document versions trails Adobe Sign tracks the review and approval process These features combine to form a complete audit trail 11.10 (f ) Operational system checks The workflow is managed by Power Automate which is effectively the operational system Every run of the system can be examined at each process step and evaluated for completion and elapsed time 11.10 (g) Authority checks Access to the SharePoint library and its documents is managed by a SharePoint administra- tor who assigns user privileges Adobe Sign requires pre-selected document reviewers to login and defines user privileges in accordance with their assigned roles 11.10 (h) Device checks UPMC login is required to access the local network on which SharePoint is hosted Users must sign into their Microsoft account to access the SharePoint document library 11.10 (i) Proof of qualifications Employee training documents are available for and reviewed by all system users 11.10 ( j) Establishment of policies that hold E-signature disclaimer on the coversheet seen in Adobe Sign at the time of signature signers responsible under their electronic signatures 11.10 (k1) Control over distribution, access, All process documents are stored in SharePoint under carefully assigned and controlled user and use permissions 11.10 (k2) Revision and change control proce- Documentation pertaining to this document control process will be kept under the same dure and their audit trail protocols it enforces Document libraries include SharePoint versioning and Adobe Sign audit trails 11.50 (a) Signed records must contain the All fields are present on the Adobe Sign Template signer’s printed name, date, and All informatization, minus the signature, is automatically generated at the time of signature time of signature, and the meaning of the signature 11.50 (b) All information required in 11.50 Signed document is exported to the SharePoint Live Documents library as a PDF file, which (a) will be available to the reader in has the signatures and associated information on the coversheet both digital and physical format 11.70 Signature/record linking Managed and controlled by Adobe Sign which is a Part 11 compliant e-signature application Lohss et al. 3D Printing in Medicine (2023) 9:5 Page 5 of 6 FDA United States Food and Drug Administration. Microsoft SharePoint is a sophisticated interface for QMS Quality Management System. document sharing across various institutions. The pro- Acknowledgements gram is compatible with all Microsoft Office products Not applicable. including Word and Excel, two widely used document Author Contribution creation programs. These products are used across ML: Literature review, manuscript writing, figure creation. EH: many institutions, making our system a viable option Conceptualization, creation of document control system, co-supervision, to implement. With the help of Power Automate, we manuscript reviewing and editing. AG: conceptualization, supervision, manuscript reviewing and editing. All authors read and approved the final were able to design a workflow that allows us to ver- manuscript. sion documents, archive edits, assign reviewers, and collect signatures in a format that is FDA compliant. Funding We acknowledge support for this research was provided by the UPMC Broadly speaking, any 3D printing program with access 3D Printing Program and the University of Pittsburgh Physician Scientist to a Microsoft Enterprise account can implement our Training Program. document control solution. Data Availability Throughout this process, access to documents is con - Power Automate programming is available from the corresponding author trolled on a document library level. A core feature of on reasonable request. SharePoint is the ability to assign read, write, and edit privileges to specific users or user groups. Both the Declarations Controlled Documents and Live Document libraries Ethics approval and consent to participate have restricted access to avoid the intentional or acci- Not applicable. dental creation of “uncontrolled” documents. In sum- mary, SharePoint is used to store and edit documents; Consent for publication Not applicable. it contains the necessary components of Part 11 except for the regulations surrounding electronic signatures. Competing interests The regulations surrounding electronic signatures, in The authors declare that they have no competing interests. turn, are met by Adobe Sign. The resulting DCS can Received: 22 December 2022 / Accepted: 7 March 2023 store documents and collect signatures all within a transparent, traceable format. Future goals for improvement are to allow system users to actively change and manage orders within the review workflow. We would also like to link documents References with electronic health records when applicable. Other 1. Chan HN, Tan MJA, Wu H. Point-of-care testing: applications of 3D printing. improvements will include risk management work- Lab Chip. 2017 Aug 8;17(16):2713–2739. https://doi.org/10.1039/c7lc00397h. flows and the automatic creation of design history files PMID: 28702608. 2. Sheth R, Balesh ER, Zhang YS, Hirsch JA, Khademhosseini A, Oklu R. Three- to further track 3D printing activities. Dimensional Printing: an enabling technology for IR. J Vasc Interv Radiol. 2016 Jun;27(6):859–65. https://doi.org/10.1016/j.jvir.2016.02.029. Epub 2016 Conclusion Apr 23. PMID: 27117948. 3. Sharma N, Aghlmandi S, Cao S, Kunz C, Honigmann P, Thieringer FM. Quality Overall, regardless of external regulation, our 3D Characteristics and Clinical Relevance of In-House 3D-Printed Customized printing team strives to provide high-quality additive Polyetheretherketone (PEEK) Implants for Craniofacial Reconstruction. J Clin manufacturing support to our healthcare community. Med. 2020 Aug 31;9(9):2818. https://doi.org/10.3390/jcm9092818. PMID: 32878160; PMCID: PMC7563642. To meet the highest of standards, a detailed DCS is 4. Zoabi A, Redenski I, Oren D, Kasem A, Zigron A, Daoud S, Moskovich L, necessary to define protocols, track information, and Kablan F, Srouji S. 3D Printing and virtual Surgical planning in oral and maxil- process prints at a high volume. Our hybrid solution lofacial surgery. J Clin Med. 2022 Apr;24(9):2385. https://doi.org/10.3390/ jcm11092385. PMID: 35566511; PMCID: PMC9104292. for document control provides an affordable system 5. Zabaleta J, Aguinagalde B, López I, Laguna SM, Mendoza M, Galardi A, Matey for users to sort, manage, store, edit, and sign docu- L, Larrañaga A, Baqueriza G, Izeta A. Creation of a multidisciplinary and ments. We hope our system can serve as a framework multicenter study group for the use of 3D printing in general thoracic sur- gery: lessons learned in our first year experience. Med Devices (Auckl). 2019 for other 3D printing programs to prepare for future May;2:12:143–9. PMID: 31118837; PMCID: PMC6506011. FDA regulations, improve the efficiency of 3D printing 6. Discussion Paper. 3D Printing Medical Devices at the Point of Care. https:// at the point-of-care, and enhance the quality of work www.fda.gov/medical-devices/3d-printing-medical-devices/3d-printing- medical-devices-point-care-discussion-paper. Accessed 10 October 2022. produced by their respective program. 7. Horst A, McDonald F, Hutmacher DW. A clarion call for understanding regula- tory processes for additive manufacturing in the health sector. Expert Rev List of Abbreviations Med Devices. 2019 May;16(5):405–12. Epub 2019 Apr 30. PMID: 31037978. CAPA Corrective and Preventative Action. 8. Daoud GE, Pezzutti DL, Dolatowski CJ, Carrau RL, Pancake M, Herderick CFR Code of Federal Regulations. E, VanKoevering KK. Establishing a point-of-care additive manufacturing DCS Document Control System. workflow for clinical use. J Mater Res. 2021;36(19):3761–80. https://doi. DHF Design History File. Lohss et al. 3D Printing in Medicine (2023) 9:5 Page 6 of 6 org/10.1557/s43578-021-00270-x. Epub 2021 Jul 6. PMID: 34248272; PMCID: 11. CFR - Code of Federal Regulations Title 21. https://www.accessdata.fda.gov/ PMC8259775. scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820. Accessed 10 October 9. Beitler BG, Abraham PF, Glennon AR, Tommasini SM, Lattanza LL, Morris JM, 2022. Wiznia DH. Interpretation of regulatory factors for 3D printing at hospitals 12. Part, 11. Electronic Records; Electronic Signatures - Scope and Application. and medical centers, or at the point of care. 3D Print Med. 2022 Feb 1;8(1):7. https://www.fda.gov/regulatory-information/search-fda-guidance-docu- https://doi.org/10.1186/s41205-022-00134-y. PMID: 35106697; PMCID: ments/part-11-electronic-records-electronic-signatures-scope-and-applica- PMC8809025. tion. Accessed 10 October 2022. 10. Bastawrous S, Wu L, Liacouras PC, Levin DB, Ahmed MT, Strzelecki B, Amendola MF, Lee JT, Coburn J, Ripley B. Establishing 3D Printing at the Publisher’s Note Point of Care: Basic Principles and Tools for Success. Radiographics. 2022 Springer Nature remains neutral with regard to jurisdictional claims in Mar-Apr;42(2):451–468. https://doi.org/10.1148/rg.210113. Epub 2022 Feb 4. published maps and institutional affiliations. PMID: 35119967. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png 3D Printing in Medicine Springer Journals

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

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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. Keywords 3D printing, Additive manufacturing, Quality management system, Quality control, Document control, Regulatory, CFR Part 11 Introduction testing, creating new opportunities for surgical planning, Point-of-care 3D printing is a growing sector of health- decreasing time spent in the operating room, reducing care, currently being practiced across various academic medical errors, and ultimately improving patient care medical centers and private clinics [1]. Healthcare sys- and satisfaction [3–5]. tems have adopted 3D printing technologies to create As 3D printing expands into more clinical settings patient-specific anatomic models, surgical guides, and and broadens in its applications, the demand for robust other custom medical devices [2]. The use of 3D print - quality control grows. Most 3D printing programs can ing in the clinical environment is improving diagnostic be divided into three categories. Programs are either (1) developed in collaboration with a separate manufactur- ing company, (2) established internally under a hospital *Correspondence: department, or (3) developed as combination of both Anish Ghodadra external and internal manufacturing facilities [6]. These ghodadraa@upmc.edu UPMC Department of Radiology, 200 Lothrop St, Pittsburgh, PA different implementation strategies, as well as advance - 15213, USA ments in 3D printing technology, have made 3D printing University of Pittsburgh School of Medicine, 3550 Terrace St, Pittsburgh, more accessible for both large and small institutions. To PA 15213, USA © The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Lohss et al. 3D Printing in Medicine (2023) 9:5 Page 2 of 6 ensure that this rapid growth of 3D printing in healthcare concerns. To overcome these challenges, we present our settings continues to be safe and effective, robust quality internally developed, cost-effective solution for an elec - management infrastructure is critical [7–10]. With the tronic DCS for 3D printing at the point-of-care. U.S. Food and Drug Administration (FDA) releasing a In anticipation of FDA regulation of 3D printing and discussion paper on regulation of 3D printing in 2021, it to ensure that our printed parts are of the highest qual- is only a matter of time until formal regulation is placed ity, our 3D printing team created an FDA-compliant on 3D printing programs. As hinted by the FDA, this DCS that provides a cheaper, tailored alternative to tra- regulation could be as stringent as that of a traditional ditional solutions. We developed a hybrid system that medical device manufacturer [6]. The discussion paper uses an existing document management program to cre- also states that 3D printing entities should understand ate an internally managed DCS. Our solution provides a the existing requirements for medical device regulation streamlined workflow that can be easily implemented and and comply to the Quality System Regulation under Title modified. Our system is also capable of supplying docu - 21 Code of Federal Regulations (CFR) Part 820 (21 CFR ment templates, tracking version history, and collecting Part 820). This document was released by the FDA in electronic signatures, all while automatically generating 1978 to establish regulatory requirements for the meth- an FDA-compliant audit trail. The hybrid document con - ods, facilities, and controls used to produce medical trol platform can be easily implemented at a low cost by devices [11]. To meet 21 CFR Part 820 compliance, the any 3D printing team in a clinical environment, prepar- FDA requires the establishment of a quality management ing this new sector of healthcare for FDA regulation. system (QMS). A QMS functions as a formalized method for documenting processes, procedures, and respon- Methods sibilities to ensure that medical devices meet specified Document control system requirements for 3D printing requirements. Within the QMS, the FDA requires the Before developing our document control system, we out- use of a document control system (DCS) that is compli- lined system requirements based on existing guidance. ant with CFR Part 11, the FDA guidelines for electronic Requirements were developed according to 21 CFR Part record collection [12]. A DCS is a formalized process for 820 and CFR Part 11. We divided requirements into two the organization, tracking, signature collection, and dis- categories. The first category contains required features. tribution of manufacturing documentation. While off- These are features that are necessary for FDA compliance the-shelf solutions for a DCS exist, these are often costly and overall quality assurance. The second category con - and require use of Software as a Service systems which tains additional desired features which are nonessential. hospitals are hesitant to adopt due to network security Rather, these are features that make the platform easier to use, further streamline the workflow, and expand the Table 1 Features for our 3D printing DCS. system’s applications. These requirements are described Required features Desired features below in Table 1. Document control (versioning, archiving, etc.) Structure and templates designed for medical Evaluation of existing software applications device development After outlining system requirements, we evaluated exist- Electronic signoffs/approvals with CFR Part 11 Connectivity between ing software applications. The applications we explored compliance documents (live links to referenced documents) included Greenlight Guru (Greenlight Guru, IN, USA), Ability to store overarching standard operat- Design history file Qualio (Qualio, CA, USA), Solidworks PDM (SolidWorks ing procedures, work instructions, records, (DHF) creation Corporation, MA, USA), Compass (Cognition Corpora- etc. related to program’s infrastructure/poli- tion, MA, USA), MasterControl (MasterControl, Inc., cies ( Word documents, Excel spreadsheets) UT, USA), ETQ (Hexagon AB, Stockholm, Sweden), Ability to sort standard operating procedures, Complaint Arena (PTC, Inc., MA, USA), Qualtrax (Ideagen PLC, work instructions, records, etc. by project management ( Word documents, Excel spreadsheets) Nottingham, United Kingdom), and TrackWise (Sparta Creation of FDA-compliant audit documents Change order Systems, Inc., NJ, USA). Many of these applications have management well-designed user interfaces and technical capabilities Corrective and preven- to meet all required and desired features. Unfortunately, tative action (CAPA) these programs are expensive with costs significantly subsystem increasing as the number of dedicated users increases. Management of em- Additionally, security concerns pose a significant chal - ployee training lenge when working with external software platforms. Consulting services Patient information must be protected, and hospital soft- (related to CFR Part 820) ware security standards must be followed. Risk management capabilities Lohss et al. 3D Printing in Medicine (2023) 9:5 Page 3 of 6 Customized internal systems, on the other hand, can be in a Review Queue where users can see who has seen, designed to create individualized document control solu- approved, or rejected various documents. tions with an internal support team and acceptable secu- Our document control platform is structured in six rity protocols. The downside is that creating a completely sections, demonstrated in Fig.  1. Within Fig.  1, each custom DCS takes a significant amount of time and can section is labeled by a red box as either a SharePoint be significantly expensive. library, Power Automate program, or an Adobe Sign signature collector. The blue boxes summarize the Creation of a hybrid document control system function of a particular section. Yellow arrows rep- Our proposed solution is a hybrid document control resent the movement of a document from section to system. We have linked two commercially available plat- section. forms, Microsoft SharePoint (Microsoft Corporation, The first section, Controlled Documents, is where a WA, USA) and Adobe Sign (Adobe, CA, USA), using a user selects a template for document creation. Within customized workflow which allows for robust document this section, a user can edit the new document, select management. a hierarchy of reviewers, and send the document for We adapted SharePoint, a Microsoft product for shar- review. After sending the document for review, the ing and editing documents, along with Adobe Sign, a Part Agreement Creator is initiated. This section is a Power 11-compliant electronic signature collection service, to Automate program that creates an iterated version create a traceable DCS. The two platforms are connected of the document for review and combines it with an by Microsoft Power Automate, a programming applica- Adobe Sign template. This combination of document tion that allows for the development of automated work- and template are referred to as an “Agreement” within flows between various Microsoft and non-Microsoft Adobe Sign. platforms. With this automation, a document created The Adobe Sign agreement is then funneled to the in SharePoint can be assigned to reviewers and submit- Agreement Tracker. The Agreement Tracker is a sepa- ted for review and electronic signatures. The program rate Power Automate program that tracks the status of automatically sends the document to assigned reviewers an agreement within Adobe Sign’s Signature Collector and collects signatures via Adobe Sign. During the entire and reflects status changes to users via a SharePoint list process, documents are actively versioned and stored called Review Queue. The Signature Collector is housed within Adobe Sign to collect signatures and create an Fig. 1 Schematic diagram of our hybrid DCS. Lohss et al. 3D Printing in Medicine (2023) 9:5 Page 4 of 6 audit trail. Reviewers can perform three major actions; Results they can accept, reject, or cancel the agreement. If the For a DCS to be FDA compliant, it must meet the guid- reviewer performs any of these three actions, an update ances of CFR Part 11 for electronic signature collection is sent to the Agreement Tracker section which is further and document protection. Within our system, we use reflected in the Review Queue. Rejecting or canceling the Adobe Sign which is already considered Part 11 com- agreement automatically sends the document back to pliant as a legally binding signature collection platform. the document creator with comments and edits from the Table 2 outlines all CFR Part 11 subsections and specifies reviewer. If an agreement has been reviewed, accepted, how our system meets each guideline. and signed by all parties, the Agreement Tracker converts Section  11.30 of Part 11 is not considered because we the Agreement to a PDF document, attaches the audit operate within a closed system, internal to UPMC. All trail generated by Adobe Sign, and saves the document other sections were carefully examined when creating to the final section of the software, the Live Documents our platform. library. Documents in the Live Documents library are considered official published records and can be viewed Discussion by all users. Our hybrid DCS provides an affordable, customizable option for point-of-care 3D printing groups. Using a hybrid approach, we leverage the advantages of both existing software platforms and customized workflows. Table 2 CFR part 11 guidances and how our DCS accounts for each subsection CFR Part 11 Subsection guideline How our system meets guideline subsection 11.10 (a) Validation of systems Performance qualification document generated with FDA audit trail 11.10 (b) Generation of accurate and com- Documents are stored as Microsoft Word documents and PDF files plete digital and physical copies of records 11.10 (c) Protection of records SharePoint-managed groups and permissions with account passwords 11.10 (d) Access limitations SharePoint-managed groups and Microsoft account passwords Individual documents can be further password protected if necessary 11.10 (e) Creation of time-stamped audit SharePoint tracks all changes to document versions trails Adobe Sign tracks the review and approval process These features combine to form a complete audit trail 11.10 (f ) Operational system checks The workflow is managed by Power Automate which is effectively the operational system Every run of the system can be examined at each process step and evaluated for completion and elapsed time 11.10 (g) Authority checks Access to the SharePoint library and its documents is managed by a SharePoint administra- tor who assigns user privileges Adobe Sign requires pre-selected document reviewers to login and defines user privileges in accordance with their assigned roles 11.10 (h) Device checks UPMC login is required to access the local network on which SharePoint is hosted Users must sign into their Microsoft account to access the SharePoint document library 11.10 (i) Proof of qualifications Employee training documents are available for and reviewed by all system users 11.10 ( j) Establishment of policies that hold E-signature disclaimer on the coversheet seen in Adobe Sign at the time of signature signers responsible under their electronic signatures 11.10 (k1) Control over distribution, access, All process documents are stored in SharePoint under carefully assigned and controlled user and use permissions 11.10 (k2) Revision and change control proce- Documentation pertaining to this document control process will be kept under the same dure and their audit trail protocols it enforces Document libraries include SharePoint versioning and Adobe Sign audit trails 11.50 (a) Signed records must contain the All fields are present on the Adobe Sign Template signer’s printed name, date, and All informatization, minus the signature, is automatically generated at the time of signature time of signature, and the meaning of the signature 11.50 (b) All information required in 11.50 Signed document is exported to the SharePoint Live Documents library as a PDF file, which (a) will be available to the reader in has the signatures and associated information on the coversheet both digital and physical format 11.70 Signature/record linking Managed and controlled by Adobe Sign which is a Part 11 compliant e-signature application Lohss et al. 3D Printing in Medicine (2023) 9:5 Page 5 of 6 FDA United States Food and Drug Administration. Microsoft SharePoint is a sophisticated interface for QMS Quality Management System. document sharing across various institutions. The pro- Acknowledgements gram is compatible with all Microsoft Office products Not applicable. including Word and Excel, two widely used document Author Contribution creation programs. These products are used across ML: Literature review, manuscript writing, figure creation. EH: many institutions, making our system a viable option Conceptualization, creation of document control system, co-supervision, to implement. With the help of Power Automate, we manuscript reviewing and editing. AG: conceptualization, supervision, manuscript reviewing and editing. All authors read and approved the final were able to design a workflow that allows us to ver- manuscript. sion documents, archive edits, assign reviewers, and collect signatures in a format that is FDA compliant. Funding We acknowledge support for this research was provided by the UPMC Broadly speaking, any 3D printing program with access 3D Printing Program and the University of Pittsburgh Physician Scientist to a Microsoft Enterprise account can implement our Training Program. document control solution. Data Availability Throughout this process, access to documents is con - Power Automate programming is available from the corresponding author trolled on a document library level. A core feature of on reasonable request. SharePoint is the ability to assign read, write, and edit privileges to specific users or user groups. Both the Declarations Controlled Documents and Live Document libraries Ethics approval and consent to participate have restricted access to avoid the intentional or acci- Not applicable. dental creation of “uncontrolled” documents. In sum- mary, SharePoint is used to store and edit documents; Consent for publication Not applicable. it contains the necessary components of Part 11 except for the regulations surrounding electronic signatures. Competing interests The regulations surrounding electronic signatures, in The authors declare that they have no competing interests. turn, are met by Adobe Sign. The resulting DCS can Received: 22 December 2022 / Accepted: 7 March 2023 store documents and collect signatures all within a transparent, traceable format. Future goals for improvement are to allow system users to actively change and manage orders within the review workflow. We would also like to link documents References with electronic health records when applicable. Other 1. Chan HN, Tan MJA, Wu H. 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Journal

3D Printing in Medicine – Springer Journals

Published: Mar 17, 2023

Keywords: 3D printing; Additive manufacturing; Quality management system; Quality control; Document control; Regulatory; CFR Part 11

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