Digitalised validation systems as an enabler for quality 4.0 within a medical device manufacturer
Purpose: This research examines the implementation challenges and benefits of transitioning to a paperless validation system as part of a Quality 4.0 initiative within a Medical Device manufacturer in order to address a gap related to such studies in the literature. Methodology: This research was co...
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| Format: | Article |
| Language: | English |
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Elsevier
2024-12-01
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| Series: | Sustainable Futures |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2666188824002326 |
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| author | Olivia McDermott Neasa Conroy M. Thenarasu Susana Duarte |
| author_facet | Olivia McDermott Neasa Conroy M. Thenarasu Susana Duarte |
| author_sort | Olivia McDermott |
| collection | DOAJ |
| description | Purpose: This research examines the implementation challenges and benefits of transitioning to a paperless validation system as part of a Quality 4.0 initiative within a Medical Device manufacturer in order to address a gap related to such studies in the literature. Methodology: This research was conducted using a case study executed in a large medical device manufacturing facility. The study followed the successful implementation of a digitalised validation system using the Design for Six Sigma methodology to move away from a heavily paper-based validation process as part of the site Quality 4.0 strategy. Findings: Digitalised validation systems have benefits, including more sustainable processes with the elimination of paper, a streamlined review and approval process, and the successful management of data integrity for large volumes of validation data while also decreasing opportunities for audit findings. The challenges encountered by the site during implementation were ensuring end users of these systems had adequate training, overcoming resistance to change, upskilling, and maintaining well-managed change communication. Limitations/Implications: This study was conducted at a single site, but the research enables documentation of an unprecedented longitudinal case study conducted over a 2-year implementation and 1-year post-implementation period and gives unprecedented insight into the practical challenges of deploying paperless validation systems in a large medical device manufacturer. The study also makes a contribution to knowledge sharing within the Medtech industry. Originality/Value: This research project is one of the first longitudinal studies in a large medical device manufacturer to document a Quality 4.0 case study around transitioning to a paperless validation system in a regulated industry and thus fulfils a gap in the literature. Medtech professionals can leverage the work to benchmark the challenges and benefits of paperless validation in maintaining and improving regulatory compliance, quality, environmental sustainability and employee morale. |
| format | Article |
| id | doaj-art-4f231e95a265412da6dd89243c2e492c |
| institution | Kabale University |
| issn | 2666-1888 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Sustainable Futures |
| spelling | doaj-art-4f231e95a265412da6dd89243c2e492c2024-12-18T08:52:52ZengElsevierSustainable Futures2666-18882024-12-018100383Digitalised validation systems as an enabler for quality 4.0 within a medical device manufacturerOlivia McDermott0Neasa Conroy1M. Thenarasu2Susana Duarte3College of Science & Engineering, University of Galway, Galway, Ireland; Corresponding author.College of Science & Engineering, University of Galway, Galway, IrelandDepartment of Mechanical Engineering, Amrita School of Engineering, Amrita Vishwa Vidyapeetham, Coimbatore, IndiaUNIDEMI, Department of Mechanical and Industrial Engineering, NOVA School of Science and Technology, Universidade NOVA de Lisboa, 2829-516 Caparica, Portugal/Laboratório Associado de Sistemas Inteligentes, LASI, 4800-058 Guimarães, PortugalPurpose: This research examines the implementation challenges and benefits of transitioning to a paperless validation system as part of a Quality 4.0 initiative within a Medical Device manufacturer in order to address a gap related to such studies in the literature. Methodology: This research was conducted using a case study executed in a large medical device manufacturing facility. The study followed the successful implementation of a digitalised validation system using the Design for Six Sigma methodology to move away from a heavily paper-based validation process as part of the site Quality 4.0 strategy. Findings: Digitalised validation systems have benefits, including more sustainable processes with the elimination of paper, a streamlined review and approval process, and the successful management of data integrity for large volumes of validation data while also decreasing opportunities for audit findings. The challenges encountered by the site during implementation were ensuring end users of these systems had adequate training, overcoming resistance to change, upskilling, and maintaining well-managed change communication. Limitations/Implications: This study was conducted at a single site, but the research enables documentation of an unprecedented longitudinal case study conducted over a 2-year implementation and 1-year post-implementation period and gives unprecedented insight into the practical challenges of deploying paperless validation systems in a large medical device manufacturer. The study also makes a contribution to knowledge sharing within the Medtech industry. Originality/Value: This research project is one of the first longitudinal studies in a large medical device manufacturer to document a Quality 4.0 case study around transitioning to a paperless validation system in a regulated industry and thus fulfils a gap in the literature. Medtech professionals can leverage the work to benchmark the challenges and benefits of paperless validation in maintaining and improving regulatory compliance, quality, environmental sustainability and employee morale.http://www.sciencedirect.com/science/article/pii/S2666188824002326DigitalisationQuality 4.0Medical deviceIndustry 4.0Sustainability |
| spellingShingle | Olivia McDermott Neasa Conroy M. Thenarasu Susana Duarte Digitalised validation systems as an enabler for quality 4.0 within a medical device manufacturer Sustainable Futures Digitalisation Quality 4.0 Medical device Industry 4.0 Sustainability |
| title | Digitalised validation systems as an enabler for quality 4.0 within a medical device manufacturer |
| title_full | Digitalised validation systems as an enabler for quality 4.0 within a medical device manufacturer |
| title_fullStr | Digitalised validation systems as an enabler for quality 4.0 within a medical device manufacturer |
| title_full_unstemmed | Digitalised validation systems as an enabler for quality 4.0 within a medical device manufacturer |
| title_short | Digitalised validation systems as an enabler for quality 4.0 within a medical device manufacturer |
| title_sort | digitalised validation systems as an enabler for quality 4 0 within a medical device manufacturer |
| topic | Digitalisation Quality 4.0 Medical device Industry 4.0 Sustainability |
| url | http://www.sciencedirect.com/science/article/pii/S2666188824002326 |
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