# Implementing an eQMS after Switching from Paper

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2023-02-02
- Length: 31m
- Episode: 304
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-02-implementing-an-eqms-after-switching-from-paper
- Listen: https://podcast.greenlight.guru/episode/implementing-an-eqms-after-switching-from-paper

## Summary

Kendyl Williams, a Medical Device Guru at Greenlight Guru, details her experience transitioning a medical device company from a paper-based Quality Management System (QMS) to the Greenlight Guru eQMS platform. She describes the logistical failures of the paper system, such as 'document signing parties' and lost binders, and explains how the team validated the new software by locking themselves in a coffee shop to test workflows. Williams highlights the importance of using the sandbox environment to learn the system without risking live data and emphasizes the need for intentional setup regarding document nomenclature and attributes to ensure traceability between risk and design controls.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-02-implementing-an-eqms-after-switching-from-paper#t=0) Introduction: Kendyl Williams and Greenlight Guru
- [3:55](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-02-implementing-an-eqms-after-switching-from-paper#t=235) The Pain Points of Paper-Based QMS and Document Signing Parties
- [8:10](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-02-implementing-an-eqms-after-switching-from-paper#t=490) The Catalyst for Switching to Greenlight Guru at a New Jersey Conference
- [9:41](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-02-implementing-an-eqms-after-switching-from-paper#t=581) Implementation Strategy: Coffee Shop Validation and Legacy Data Handling
- [13:58](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-02-implementing-an-eqms-after-switching-from-paper#t=838) Challenges with Nomenclature and Using the Sandbox Environment
- [17:49](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-02-implementing-an-eqms-after-switching-from-paper#t=1069) Product Features: Design Controls, Risk Linkage, and Attributes
- [24:25](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-02-implementing-an-eqms-after-switching-from-paper#t=1465) Advice for Implementation: Being Intentional and Managing Legacy Documents
- [27:49](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-02-implementing-an-eqms-after-switching-from-paper#t=1669) Realistic Timeline for eQMS Implementation

## Topics

- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Design for manufacturing & NPI](https://hardwarepodcasts.com/topic/design-for-manufacturing)

## Most relevant to

early-stage companies

## Mentioned

- Greenlight Guru (company)
- ISO 13485 (other)
- ISO 14971 (other)
- David Dram (other)
- Connor (other)
- Nick Tipman (other)
- It's Always Sunny in Philadelphia (other)

## Related episodes from other shows

- [S1E12 Simplifying Quality Management | Jon Speer](https://hardwarepodcasts.com/podcast/being-an-engineer/2020-06-05-s1e12-simplifying-quality-management-jon-speer) (Being an Engineer)
- [205 - Why Less Than 20% of Companies Have Started Quality 4.0](https://hardwarepodcasts.com/podcast/lets-combinate/2025-09-11-205-why-less-than-20-of-companies-have-started-quality-4-0) (Let's Combinate)
- [Digitizing Quality Management](https://hardwarepodcasts.com/podcast/the-manufacturing-executive/2022-08-09-digitizing-quality-management) (The Manufacturing Executive)
- [128 - Former FDA Inspector and Managing Consultant, Vin Cafiso: Cadavers/Autopsies, Tales from FDA Inspections, Understanding the QMSR, and Quality Culture](https://hardwarepodcasts.com/podcast/lets-combinate/2024-03-20-128-former-fda-inspector-and-managing-consultant-vin-cafiso-cadavers-autopsies-t) (Let's Combinate)
- [090 - Software Validation, Automation, No-Code Quality Tools and QMS with Harsh Thakkar](https://hardwarepodcasts.com/podcast/lets-combinate/2023-06-21-090-software-validation-automation-no-code-quality-tools-and-qms-with-harsh-thak) (Let's Combinate)

## Citing this page

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