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Greenlight Guru
Was ist Greenlight Guru?
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.
Wer verwendet Greenlight Guru?
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.
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Greenlight Guru
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Bewertungen über Greenlight Guru
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 von Greenlight Guru
vor 6 Jahren
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.
In Betracht gezogene Alternativen:
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.
In Betracht gezogene Alternativen:
Greenlight is the right choice for eQMS
Kommentare: We evaluated multiple eQMS platforms, we went with Greenlight due to functionality, ability to scale as we grow, and the extensive / pre-existing documentation that we could leverage and tailor to our needs.
Vorteile:
Building a maintaining a QMS system that is FDA compliant is far too complicated and expensive for an early stage startup. Greenlight gives you the tools and platform to follow a pre-determined process that allows you to get up and running quick, while also having the confidence that you are meeting required regulations. Team has always been super helpful with great customer support.
Nachteile:
eQMS can be complicated with lots of jargon. It does take a sustained push to become aquatinted with terminology and incorporate into you daily workflows.
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 von Greenlight Guru
vor 6 Jahren
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.
In Betracht gezogene Alternativen:
Only eQMS geared towards medical devices
Kommentare: Great experience! Customer service is quick to respond and there is a help centre and greenlight academy with tutorials for quick reference. The traceability between design controls and risk elements is in itself worth it.
Vorteile:
Wow so many things - selecting/modifying roles/permissions, creating teams, personalizing profiles, tagging documents, grouping documents, adding/uploading w/ w/out a change order, creating/activating training events, tracking training events' progress/completion, automating/completing quality events (CAPAs, nonconformance, audits and customer feedback), adding/modifying/tracing design controls i.e., user needs, design inputs/design outputs, V & V and finally adding/modifying/tracing risk items and aligning them to the project. Customer service is quick to respond and Greenlight Guru is always taking suggestions for improvement, they have even implemented some.
Nachteile:
Just some suggestions for better functionality - ability to edit tags, ability to edit training events once activated or in the case the documents assigned to a training event changes, more user friendly quality event workspace, ability to easily change between full and lite users and vice versa.
