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Essentials

START-UP KIT

Essentials include: 

  • Design Controls (1 Project)
  • Risk Management
  • Advanced Document Management (200 Docs)
  • Change Management
  • Task Management

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EASILY ACCESS AND CONTROL DOCUMENTS.

  • Part 11 Compliant E-signatures
  • Flexible Review & Approval Workflows
  • Document Revision Control
  • Proper Access & Usage

DOCUMENT YOUR DESIGN CONTROLS WITH FULL TRACEABILITY.

  • Multi-level Design Controls
  • Intuitive & Automatic Traceability Matrix
  • Digital Design Reviews
  • Living DHF

GAIN NEW VISIBILITY AND MITIGATE RISK.

  • Aligns with ISO 14971:2019
  • Integrated & Accessible Platform-wide
  • Custom Risk Acceptability Matrix
  • Living Risk Management File

Plus

ALL-IN-ONE SOLUTION

Essentials package and: 

  • Design Controls (Unlimited Projects)
  • Advanced Document Management (Unlimited Documents)
  • Training Management
  • Supplier Management
  • CAPA Management
  • Audit Management
  • Nonconformance Management
  • Complaint Management
  • Analytics

_________________________

CREATE A CONNECTED QUALITY ECOSYSTEM.

  • Purpose-built controls for medical device companies
  • Comprehensive, end-to-end, wholly traceable system
  • Effectively manage and connect design controls, risk, and quality events

STREAMLINE TEAM ACTIVITIES.

  • Efficiently organize, assign, and track training activities
  • Enhanced collaboration & productivity
  • Increase visibility & control into processes and procedures

ACHIEVE COMPLIANCE AND STAY AUDIT READY.

  • FDA, ISO, MDSAP, & EU MDR Best Practices
  • Complete Part 11 compliant audit trails
  • Quickly & easily provide objective evidence
  • More accurate & up-to-date traceability throughout the system

Professional

INTELLIGENT SOLUTION

Plus package and: 

  • Visualize
  • In-Line Document Editing*

*when available

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VISUALIZE YOUR QMS

  • See and interact with items in a centralized view
  • Understand relationships between items in your QMS
  • Virtual linking between items (powered by machine learning and natural language processing)

ANALYZE & PREDICT TRUE QUALITY 

  • Change and update recommendations powered by AI and machine learning
  • Streamline the change control process
  • Reduce risk in missing key elements of a change

DATA-DRIVEN

  • Eliminate human error in identifying relationships and building traceability
  • Increased visibility into quality performance
  • Efficiently collect and evaluate trending quality information

Guru Services

ENHANCE YOUR TEAM WITH AN EXTENSION OF OURS.

Our seasoned medical device Guru's will ensure that you have what you need for your QMS implementation to run smoothly, while also providing clarity around the regulatory process and best practices for managing quality throughout your device's lifecycle.

DEDICATED QUALITY & REGULATORY EXPERT

  • Training 
  • Quality Assurance
  • Regulatory Compliance 
  • Audit Support

QMS Templates

GET STARTED WITH THE RIGHT DOCUMENTATION.

These audit-tested procedures, work instructions, and form will streamline the implementation of your quality management system and save you time during implementation and audits.

 

AUDIT-TESTED TEMPLATES FOR YOUR QMS

  • Quality Manual
  • Management Review Template
  • Project and Risk Plans
  • Supplier Survey Forms
  • Quality Event Procedures and Templates

Still not sure which plan is right for your team? 

Give us a call. 

+1 (317) 960-4220
Customer Success

Greenlight Guru is more than just software. 

Our Customer Success team is here to do more than solve technical issues. At Greenlight Guru, we value fanatical support. That means our noteworthy Customer Success and Medical Device Guru teams on your side to ensure that you and your team are always supported and on track to achieve success. They are here to help your team implement, maintain, and extract full value from your QMS to further your business. Your outcomes shape our outcomes - when you succeed, so do we.

 

Phone, Video Meeting, and Email Support

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Help Documentation & Live Training

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Industry Knowledge & Support Access

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G2-Crowd

G2 Crowd provides real-time and unbiased user reviews to help you objectively assess what software is best for your business.

Read All Reviews

August 7, 2017
“Fantastic Product and Even Better Team”
The GG team goes out of their way to help us meet our business objectives. They are knowledgeable in the regulatory and quality management space and are always trying to improve their software and user experience.
Ryan Shelton
Validated Reviewer
Verified Current User
March 19, 2018
“Delighted with Both the Product and the Service”

We searched for a digital solution to see if one was available after being told that only paper-based systems would satisfy FDA. We found Greenlight Guru and have been delighted with both the product and the service. Greenligh Guru gives us a digital QMS so that we can safely launch our first four products. We feel confident our system can withstand any FDA audits.

Thomas Gardner
Validated Reviewer
Verified Current User
April 2, 2018
“Great eQMS system with Great Customer Support team”
Greenlight Guru is always listening to customer's voice and making improvements to the software. The Customer Support team is also very helpful whenever I have questions about how the software works. Once setup, it reduces the time it takes to maintain the Quality System or prepare for an audit.
James Wu
Validated Reviewer
Verified Current User
April 24, 2018
“Design Controls Lifesaver!”
The design controls & risk management platform is beautiful. It saves a ton of time updating design controls and risk management inputs & outputs that would normally require multiple document updates with each change. This platform makes it so easy to document and capture the whole design & risk management process so easily. Consider the business savings to having all document control, risk management, and design controls at your fingertips and not requiring paper solutions. This platform removes the frustration of giant excel documents that inevitably fail to be properly updated. It usually t...
Read the Full Review
Christie Johnson
Validated Reviewer
Verified Current User
April 24, 2018
“Great eQMS Software”
The software is easy to use with little to no customization needed. It has been a great tool for developing our device through design control. The post-market additions have been amazing as well as tasks. After using multiple types of eQMS software over the years this is the best by far! Quality system related activities such as revision control, storage, and validation are easily tracked and completed within the software. We also have a team of engineers around the country so using Greenlight Guru for design and risk has improved our collaboration and efficiency.
Administrator
Validated Reviewer
Verified Current User
April 26, 2018
“Wonderful eQMS and Team! ”

The DC and Risk matrices make Greenlight Guru a great software for medical device companies. The ability to link the design controls and risk elements together allow companies to develop safe and effective devices. The application also allows our teams to work together from different locations in order to accommodate everyone's schedules! The Greenlight Guru software keeps a log of all changes made in the system. This means each time a user views, edits, approves, rejects, etc. an input in the software, the data is captured and can be pulled for reference. This allows for traceability...
Read the Full Review

Consultant in Medical Devices
Validated Reviewer
Verified Current User
May 11, 2018
“My QMS is World Class”

The software allows me to mitigate my regulatory and compliance risk, I have been able to implement a world class eQMS that rivals the largest companies in med device. Greenlight has the best in class support, it is both software and service.

Dan Holton
Validated Reviewer
Verified Current User
May 22, 2018
“One Stop Shop for MD QMS”
I love that everything is 'under one roof', the design, document control, training, change management, NC,s CAPAs, Feedback and Audits. I really love the risk within design, it is set out clearly, easy to use and clear to see the risks at a glance. I also love that Greenlight have a continual improvement approach and new features being added to enhance the usability and performance from time to time. Also, their customer service is top class. I really don't know how I would do my job without it!
Maria McGrady
Validated Reviewer
July 18, 2018
“Medical Device QMS system compliant and ready to use out of the box”
Greenlight Guru is fully focused on medical device manufacturers. As a result, it provides ISO 13485 and FDA QSR compliant methods out of the box with no setup. It is also deployed and maintained by GG reducing any associated hassle. In addition, they provide validation protocols and reports which eliminates that obstacle as well. Overall there is almost no overhead in using this system (installation, backup, updates, validation are all covered by GG) while it does remove a lot of the overhead of a paper system. It is straightforward in use and functionality is continuously added to cover more...
Read the Full Review
Niels Festjens
Validated Reviewer
Verified Current User
August 3, 2017
“Positive Greenlight Guru Experience”

Real time reviewing and publishing of quality documents. GUI of website makes it very easy to navigate without any hassle.

Kevin N.
Validated Reviewer
Verified Current User
August 4, 2017
“Amazing”

The support at Greenlight Guru has been incredible. There is live chat available and any question [is answered] in a matter of minutes! This extends beyond just how does system support. Greenlight Guru is able to answer questions related to ensuring that your system is compliant to the necessary standards required for medical devices.

Administrator in Consumer Goods
Validated Reviewer
August 3, 2017
“Easy to Use”

Easy to upload, organize, and find documents

User in Biotechnology
Validated Reviewer
Verified Current User

Frequently Asked Questions

Do I need to buy onboarding services?
Are there any overage fees? Or data limitations?
Will I have to pay for software upgrades?
How is the software deployed?
What type of support is available to users?
Still not sure how Greenlight Guru’s medical device QMS software can help your business? Talk with us.
+1 (317) 960-4220