Medical Device QMS Software

Medical Device QMS Software

von Greenlight Guru

Wer verwendet Medical Device QMS Software?

Greenlight Guru ist eine ideale Lösung für Medizingeräteunternehmen, die Zeit und Geld sparen möchten, wenn sie ihr Produkt auf den Markt bringen. Zu den Kunden gehören Mitarbeiter mit QA-/RA-Aufgaben, Ingenieure und Führungskräfte gleichermaßen.

Was ist Medical Device QMS Software?

Greenlight Guru ist eine elektronische Qualitätsmanagementsoftware (eQMS), die von medizinischen Fachkräften entwickelt wurde und speziell auf die besonderen Bedürfnisse von Medizingeräteunternehmen zugeschnitten ist. Die umfassende, sofort einsatzbereite Lösung basiert auf den neuesten FDA- und ISO-Standards und Best Practices, die sorgfältig in jede Funktion innerhalb der cloudbasierten Plattform integriert wurden. Schließe dich Hunderten von anderen Medizinprodukteherstellern an, die mit dem Unternehmen zusammenarbeiten und verlagere deinen Schwerpunkt von reiner Konformität auf echte Qualität.

Medical Device QMS Software – Details

Greenlight Guru

http://greenlight.guru

Gegründet 2013

Medical Device QMS Software – Preisübersicht

Medical Device QMS Software bietet keine Gratisversion und keine kostenlose Testversion. Weitere Preisinformationen für Medical Device QMS Software findest du unten.

Kostenlose Version

Nein

Gratis Testen

Nein

Einsatz

Cloud, SaaS, Web

Training

Live Online

Webinare

Dokumentation

Kundenbetreuung

24/7 (Live Vertreter)

Support während der Geschäftszeiten

Online

Medical Device QMS Software Funktionen

CAPA-Systeme (Corrective and Preventive Action)
Beschwerdemanagement
CAPA-Planung
Nachverfolgung von Nicht-Einhaltungen
Qualitätskontrolle
Risikomanagement
Störfallmanagement
Trainingsmanagement
Ursachenanalyse
Veränderungsmanagement
Wirtschaftsprüfung-Management
Beschwerdemanagement
Compliance Management
Corrective and Preventive Action (CAPA)
Dokumentenkontrolle
Geräte-Management
ISO-Standard-Management
Instandhaltungsmanagement
LieferantenQualitätskontrolle
Risikomanagement
Trainingsmanagement
Verfolgen von Fehlern
Wirtschaftsprüfung-Management

Medical Device QMS Software – Nutzerbewertungen

Zeigt 5 von 60 Nutzerbewertungen

Gesamt
4.5/5
Benutzerfreundlichkeit
4.2/5
Kundenservice
4.8/5
Funktionen
4.2/5
Preis-Leistungs-Verhältnis
4.4/5
Sarah K.
President & Chief Operating Officer
Krankenhausversorgung & Gesundheitswesen, 2-10 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
  • Gesamtbewertung
    5/5
  • Benutzerfreundlichkeit
    5/5
  • Eigenschaften & Funktionalitäten
    5/5
  • Kundenbetreuung
    5/5
  • Preis-Leistungs-Verhältnis
    5/5
  • Wahrscheinlichkeit der Weiterempfehlung
    10/10
  • Quelle des Nutzers 
  • Bewertet am 11.12.2018

"A god-send of a QMS"

Kommentare: As a new medtech company with many different product and differing product regulations, we are pleased to have Quality Management as one of our easiest tasks - which is rare to say. The team is fantastic and abundantly helpful, the system is quick to learn and easy to use, and the support you get standing the system up from scratch if you don't already have a system in place is great. We needed Quality "handled" so we could focus on the trickier parts of our company - Greenlight Guru was and is that perfect solution.

Vorteile: With GG, it is structured and organized to not just allow compliance, it promotes compliance - meaning using the software as it is built easily documents for product design/dev and ongoing quality req'ts. It's easy to use and navigate, quick to learn even for lay people, and makes our QMS regulatory headache-free.

Nachteile: The team keeps making improvements, and I'm looking forward to a bit of a better structure to the large document repository. It is searchable, tagable, and sortable easily, but there are a few other ways that they could organize things so you can find something quickly.

Antwort des Softwareanbieters

von Greenlight Guru an 14.12.2018

Hi Sarah,

The team at GG greatly values your feedback and we appreciate you taking the time share your experience working with our software and team.

Glad to hear you are excited about the upcoming enhancements to Advanced Document Management with with debut of Document Views in our December 2018 release.

We strive to simplify quality management for medical device companies of all sizes, and welcome any future feedback or enhancements ideas.

  • Quelle des Nutzers 
  • Bewertet am 11.12.2018
Chris T.
Senior Manager of QA
Medizinische Geräte, 501-1.000 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
  • Gesamtbewertung
    4/5
  • Benutzerfreundlichkeit
    4/5
  • Eigenschaften & Funktionalitäten
    4/5
  • Kundenbetreuung
    5/5
  • Preis-Leistungs-Verhältnis
    4/5
  • Wahrscheinlichkeit der Weiterempfehlung
    10/10
  • Quelle des Nutzers 
  • Bewertet am 11.3.2020

"My GG Experience"

Vorteile: GG is hands-down the most user-friendly s/w I have ever worked with. The GG team has truly created simple easy-to-use workflows, while still offering complex functionality that conforms to the rigors of ISO 13485 standards. I love how you can link tasks, documents, investigations, and CAPAs. I personally love their DMS and Customer Feedback workflows. They're easy on the eyes, tell the whole story and allow for easy routing and approving to key stakeholders.

Nachteile: GG's data analytics aren't very helpful and often inaccurate. The data they're tracking is rudimentary and seems to an after thought by the design team. Additionally, there is no reporting functionality in their Customer Complaints workflow. For example, if you're attempting to run a trend report for common root causes related to certain events, the s/w doesn't allow it. Therefore, I have to track everything outside of GG, especially for trend reports. Trend reporting and tracking is critical in any regulated industry, so I'm not sure why GG didn't think of this

  • Quelle des Nutzers 
  • Bewertet am 11.3.2020
Vineet E.
COO
Medizinische Geräte, 13-50 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
  • Gesamtbewertung
    4/5
  • Benutzerfreundlichkeit
    4/5
  • Eigenschaften & Funktionalitäten
    4/5
  • Kundenbetreuung
    5/5
  • Preis-Leistungs-Verhältnis
    4/5
  • Wahrscheinlichkeit der Weiterempfehlung
    8/10
  • Quelle des Nutzers 
  • Bewertet am 6.1.2020

"Truly Turnkey, Great for new companies"

Kommentare: Greenlight.Guru has allowed us to, from a very young, inexperienced stage, build from scratch an easy to use and comprehensive quality system that has passed external audit with ease. The customer support, user interface, and turnkey solution offered by Greenlight.Guru has exceptionally useful for us, and been the foundation for Quality Management at our company.

Vorteile: Using Greenlight.Guru, we were able to build a quality system from scratch quickly that met our needs without the headache of complicated set-up and configuration. This tool enabled us to go from nothing to passing our first audit with confidence and ease. Great tools to link design and risk with documents and approvals. The customer service was also great, and Greenlight helped build our knowledge of Medical Device Quality at the beginning of our company's life, allowing many of us to rise from inexperience to competence to near mastery of quality systems. Greenlight further offers an unparalleled user interface and intuitive tools that make using it a cinch for almost all employees at our company.

Nachteile: Understanding best practices can be a bit challenging and time consuming given that there is one standard offering for all customers and customization is intentionally not available. Being a new company, Greenlight has grown with us. Some features that would have been nice to have earlier were developed and pushed during our use of the software, though it is clear that the product is maturing to meet the needs of its customers without sacrificing the ease of use.

  • Quelle des Nutzers 
  • Bewertet am 6.1.2020
Dieu W.
Quality Manager
Medizinische Geräte, 13-50 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
  • Gesamtbewertung
    3/5
  • Benutzerfreundlichkeit
    4/5
  • Eigenschaften & Funktionalitäten
    2/5
  • Kundenbetreuung
    5/5
  • Preis-Leistungs-Verhältnis
    3/5
  • Wahrscheinlichkeit der Weiterempfehlung
    4/10
  • Quelle des Nutzers 
  • Bewertet am 15.11.2016

"More functionality preferred"

Kommentare: Overall the software is easy to use, but there are a few functionality that we wish were there, specifically:
- parallel approvers
- ability to attach redlines as part of routing (and then ability to publish clean copy); now it forces you to review redlines offline (not great since it gets lost in people's email, etc.)
- ability to reassign who can publish the document (if person who routed it is out and doc control/quality should be able to publish for them).
- ability to turn on email notifications if you have something in your inbox

Vorteile: online

Nachteile: very limited functionality

Antwort des Softwareanbieters

von Greenlight Guru an 14.12.2018

Hello, Dieu. Thank you for your feedback. We heard you, loud and clear.

As a result of your feedback, we've added parallel routing and the ability to include redlines and mark-ups to review and approval workflows.

Additionally, we've since enabled user level email notification preferences for you to better control the types of messages you'd like to receive via email.

  • Quelle des Nutzers 
  • Bewertet am 15.11.2016
Jason C.
Project Engineer
Medizinische Geräte, 2-10 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
  • Gesamtbewertung
    5/5
  • Benutzerfreundlichkeit
    5/5
  • Eigenschaften & Funktionalitäten
    5/5
  • Kundenbetreuung
    5/5
  • Preis-Leistungs-Verhältnis
    5/5
  • Wahrscheinlichkeit der Weiterempfehlung
    10/10
  • Quelle des Nutzers 
  • Bewertet am 5.11.2018

"Great software to implement and maintain a medical device QMS"

Kommentare: Overall experience is great. As a small medical device company, I can't imagine keeping up with our QMS requirements without a software platform like Greenlight Guru.

Vorteile: The design trace matrix makes the development process very straight forward and easy to use. The ability to link anything to each DTM component, and to link the DTM to the risk management module is great as well. The document management and routing/approval features are also a great tool. We've been able to implement digital versions of most of our work forms, without the need to use third party document signature programs.

Nachteile: Sometimes there is a bit of a learning curve for the various modules that they release. It would be nice if a help/guide button was available for each to walk through the module step by step.

Antwort des Softwareanbieters

von Greenlight Guru an 17.12.2018

Hey Jason:

Thank you for the positive comments and feedback.

Glad to hear that the ability to Link Anything is positively impacting your Design Control/Risk efforts and that built in workflows with eSignatures are simplifying processes.

As it relates to your feedback on getting up to speed on how to use new functionality, know that we've heard you and are actively working on a solution to help you get up to speed on how to use new functionality and what's changed in app that I believe you will be pleased with.

Don't ever hesitate to share additional feedback like this with us by phone, chat, or email at customer.success@greenlight.guru

  • Quelle des Nutzers 
  • Bewertet am 5.11.2018