Greenlight Guru is a quality management platform designed specifically for medical device companies. The platform is designed to help companies get safer products to market faster, simplify FDA and ISO regulatory compliance, and provide a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits, document control, training, design control and more. The vendor invites device makers across the globe to…
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MasterControl Quality Excellence
Score 8.5 out of 10
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The MasterControl Quality Excellence suite bundles a number of products supporting work quality and compliance including training and exams, incidents and corrective actions (CA), documents and change, and other modules.
$25,000
per year
Pricing
Greenlight Guru
MasterControl Quality Excellence
Editions & Modules
No answers on this topic
No answers on this topic
Offerings
Pricing Offerings
Greenlight Guru
MasterControl Quality Excellence
Free Trial
No
No
Free/Freemium Version
No
No
Premium Consulting/Integration Services
No
No
Entry-level Setup Fee
No setup fee
No setup fee
Additional Details
Pricing information for Greenlight Guru's Quality Management Software is supplied by the software provider or retrieved from publicly accessible pricing materials. Final cost agreements to purchase Greenlight Guru Quality Management Software must be conducted with the vendor.
Qualio did not appear to be as robust a solution as Greenlight Guru, and in particular, did not have as strong of design control and risk management capabilities for medical devices. MasterControl was too involved and expensive, and the extra benefits that MasterControl …
MasterControl Quakity Excellence was selected due to the need for a new medical device application and was best suited to meet the needs of the rest of the business that focuses on food and beverage. It was the Manufacturing Excellence module that set it apart and was a key …
The products we evaluated were considered as potential replacements for MasterControl Quality Excellence. At this time, we continue using MasterControl Quality Excellence primarily due to the significant volume of data in our system and the operational impact of a platform …
Greenlight Guru is well-suited for medical device companies. They have exceptional resources that are especially helpful for smaller, start-up type companies, including customizable SOPs, Forms, and Work Instructions, as well as countless other educational resources on focused topics like Risk Management or Auditing. Greenlight Guru is NOT currently able to be integrated into any ERP systems and therefore may be difficult for the Operations and Quality aspects of the organization if, for example, manufacturing is being performed in-house, and the ERP system is used to document all quality events. (In this case, it would be redundant to also document them in Greenlight Guru - although could potentially be useful to document investigation details.) Greenlight Guru also only allows documents to be uploaded one at a time, so for companies that want to convert their existing DHF or other QMS files into Greenlight Guru for completeness, this process could be incredibly time consuming.
The MasterControl Quality Excellence suite is well suited for the life sciences and biotechnology as well as manufacturing companies that could benefit from the regulatory compliance that this suite of products offer. This product is highly recommended for industries that want to reduce paper overhead and digitally transform their QMS into a singular location
Greenlight Guru is designed specifically for medical device companies. In that, the platform helps meet FDA and ISO regulatory requirements.
Greenlight makes document review and approval easy - navigating the system is intuitive.
The Greenlight Guru team appreciates unfiltered customer feedback. They do take the voice of the customer seriously and will work to implement feature requests.
License model can become very expensive for small startup businesses.
More development with validation and more transparent information on how the improvements and or fixes may impact the current configuration. Currently, everything is listed, but it is not tailored to my system.
More information regarding the transition of previous processes to new processes. i.e., FBS to AQEM. I am currently working on the ADV/FBS forms and will eventually transition to AQEM/ADAPT. Still, I would like more information regarding the transition to inform current stakeholders about the improvements on the horizon.
would rate MasterControl Quality Excellence a 7 out of 10 because, while it offers strong compliance tools, centralized document control, and effective audit readiness features, there are still areas that could be improved to enhance the overall user experience. The platform can sometimes feel complex and unintuitive, especially for new users, and customizing workflows to fit specific organizational needs can be challenging. Additionally, integration with other enterprise systems isn't always seamless, which can slow down processes. Despite these drawbacks, the system remains a reliable and valuable tool for maintaining quality and regulatory compliance.
Some tasks require the users and SysAdmin to access multiple modules at a time. For example: to create a training course and an exam for a document in the system, the user needs to finish creating the document in the doc module, then go to the training module to create a course and an exam separately. Ideally, from the document page we should be able to access the training course, which could have some fields auto-populated. And from there, also create and link an exam, all without leaving the document page.
The Technical Support team has grown exponentially over the last couple years. Some front line support staff are new to the system and so know less than the clients do. Back line staff are more seasoned and provide immediate assistance to the front line staff. They have an extensive knowledge bank to assist them as well as client access to most KB articles. Annual user group conference gives us chance to meet the support staff an also to resolve any outstanding issues. Any critical vendor notices are emailed immediately when found and a patch offered at the same time. These are rare, but quickly resolved.
I rated the MasterControl in-person training a 10 because it was clear, practical, and well-paced. The trainer explained concepts thoroughly and answered questions effectively. I appreciated the hands-on walkthroughs, which made it easier to understand how to apply the system in real scenarios. Overall, it was a valuable learning experience that boosted my confidence in using MasterControl.
transparent and immediate when the documents are updated. Easy to check on training and customizable to the company's expectations. Allows easy exam creation with GXP assist and the correlation between job codes and courses has proven reliable. What i would advocate is that you see who has trained on the course in the Course Infocard, to the document infocard
The implementation of MasterControl Quality Excellence was largely successful, earning an 8 out of 10. The project was well-structured, and the implementation team provided solid guidance throughout the process. Key milestones were met on time, and the system was configured to meet most of our core requirements. One of the most valuable aspects was the hands-on training and support during go-live, which helped ensure user adoption. However, there were some challenges around data migration and aligning the system’s capabilities with our existing workflows, which required more time and effort than anticipated. Overall, the experience was positive, and the lessons learned have positioned us well for future system enhancements.
Greenlight Guru definitely has the better/more easily understood UI. I've tried several other training systems and haven't bumped into any of the issues I've faced before, like my training being completed by another person or glitches within the system. Greenlight Guru is a program that doesn't take too long to learn to use and get used to using.
The products we evaluated were considered as potential replacements for MasterControl Quality Excellence. At this time, we continue using MasterControl Quality Excellence primarily due to the significant volume of data in our system and the operational impact of a platform transition. Intellect QMS emerged as a strong alternative, offering extensive, intuitive business process development tools and a wide range of built-in QMS processes out of the box. MasterControl Quality Excellence currently maintains the advantage solely because of the logistical and business burden associated with migrating to a new system.
