Name: Greenlight Guru
Rating: 9.9 (18 reviews)
Author: Greenlight Guru

Help Desk

Web and Video Conferencing

Customer Support

Batch Management Software

Development

Board Management

Business Intelligence (BI)

Collaboration

Facility Management

Operational Analytics

Privacy Policy Generators

Enterprise

Accounting

Nonprofit Accounting

Finance and Accounting

Applicant Tracking

Corporate Learning Management

Employee Recognition

Employee Scheduling

HR Management

Payroll

Stock Option Plan Administration

Talent Intelligence

Talent Management

Workforce Analytics

Workforce Management

Human Resources

AI Governance

Archiving

Build Automation

Cloud Cost Management

Cloud Storage

Data Collaboration

Data Mapping

Density-Optimized Servers

Email Encryption

Fraud Detection

IT Service Providers

Integration Platform as a Service (iPaaS)

Internet Performance Monitoring

Mainframe Monitoring

Managed DNS

Network Performance Monitoring

Network Simulation

Platform-as-a-Service (PaaS)

Robotic Process Automation (RPA)

Telecom Expense Management (TEM)

Web Scraping

Workload Automation

Zero Trust Security Solutions

Information Technology

A/B Testing

Ad Serving & Retargeting

All-in-One Marketing

Blogging

Content Management

Email Marketing

Employee Advocacy

Local Marketing

Marketing Automation

Mobile Analytics

Screen and Video Capture

Search Engine Marketing (SEM)

Social Media Management

Survey & Forms Building

Web Analytics

Website Builder

Marketing

Job Site Management

Project Management

Professional Services

Customer Relationship Management (CRM)

Revenue Operations

Sales Engagement

Social Commerce

Sales

File Integrity Monitoring

Security

Camp Management

Chargeback Management

Dental

ID Card

Laboratory Information Management

Nonprofit CRM

Vertical-Specific

Find top rated software and services based on in-depth reviews from verified users. 400+ software categories including PaaS, NoSQL, BI, HR, and more.

Qualio

MasterControl Quality Excellence

MasterControl

Arena PLM and QMS

Arena by PTC

Jama Connect

Jama Software

Propel Software

TrackWise

Sparta Systems

Polarion ALM

Siemens AG

ETQ Reliance QMS

ARIS

Software AG

Oracle Fusion Cloud PLM

Oracle

Top Rated awards to be awarded in April 2022.

Top Rated 2022

Atlassian Jira

### Document Management
While some users appreciate Greenlight Guru's document management features for their ability to streamline processes and ensure compliance, others have raised concerns about the system's limitations. Common issues highlighted include difficulties in searching for documents, challenges with embedding phases in documents, and the lack of control over which departments can access certain documents. Users also mention the time-consuming nature of tasks like NCRs, complaints, and CAPAs due to the system's restrictions on embedding documents. Despite these drawbacks, Greenlight Guru is praised for centralizing document control, enhancing organization, and facilitating project management within a single platform. (Source Reviews: [1](https://www.trustradius.com/reviews/greenlight-guru-2022-06-16-09-47-15), [2](https://www.trustradius.com/reviews/greenlight-guru-2022-06-20-13-05-42), [3](https://www.trustradius.com/reviews/greenlight-guru-2022-06-09-10-55-03), [4](https://www.trustradius.com/reviews/greenlight-guru-2022-07-14-22-21-14), [5](https://www.trustradius.com/reviews/greenlight-guru-2021-08-12-09-50-13), [6](https://www.trustradius.com/reviews/greenlight-guru-2021-08-06-09-49-30), [7](https://www.trustradius.com/reviews/greenlight-guru-2021-08-02-11-09-28), [8](https://www.trustradius.com/reviews/greenlight-guru-2021-07-29-13-58-45), [9](https://www.trustradius.com/reviews/greenlight-guru-2021-08-06-08-35-21), [10](https://www.trustradius.com/reviews/greenlight-guru-2021-08-05-15-45-17), [11](https://www.trustradius.com/reviews/greenlight-guru-2021-07-29-13-08-50), [12](https://www.trustradius.com/reviews/greenlight-guru-2021-08-05-09-51-53), [13](https://www.trustradius.com/reviews/greenlight-guru-2021-08-05-09-59-47), [14](https://www.trustradius.com/reviews/greenlight-guru-2021-08-20-20-08-17))

### Quality Management Systems (QMS
Users consistently highlight Greenlight Guru's quality management systems (qms) as a robust feature that enhances their quality management processes. The system's ability to streamline document control, training, and quality event management is widely appreciated by reviewers. Greenlight Guru's quality management systems (qms) are seen as instrumental in improving productivity and ensuring adherence to quality standards within organizations. (Source Reviews: [1](https://www.trustradius.com/reviews/greenlight-guru-2022-07-14-22-21-14), [2](https://www.trustradius.com/reviews/greenlight-guru-2022-06-20-13-05-42), [3](https://www.trustradius.com/reviews/greenlight-guru-2022-06-09-10-55-03), [4](https://www.trustradius.com/reviews/greenlight-guru-2021-08-12-09-50-13), [5](https://www.trustradius.com/reviews/greenlight-guru-2022-06-16-10-41-21), [6](https://www.trustradius.com/reviews/greenlight-guru-2021-08-20-20-08-17), [7](https://www.trustradius.com/reviews/greenlight-guru-2021-08-02-11-09-28), [8](https://www.trustradius.com/reviews/greenlight-guru-2021-07-29-13-58-45), [9](https://www.trustradius.com/reviews/greenlight-guru-2021-08-05-09-51-53), [10](https://www.trustradius.com/reviews/greenlight-guru-2021-07-29-13-08-50), [11](https://www.trustradius.com/reviews/greenlight-guru-2021-08-06-08-35-21))

### Quality Document Control
Users widely praise Greenlight Guru's efficiency in managing quality documents and training. The platform's quality document control capabilities are consistently highlighted as a strong point, with users commending its ability to streamline document approval processes, facilitate easy access to important documents, and support self-training initiatives. The positive sentiment towards Greenlight Guru's quality document control functionality underscores its value in ensuring compliance, enhancing operational efficiency, and maintaining a robust training framework within organizations. (Source Reviews: [1](https://www.trustradius.com/reviews/greenlight-guru-2022-07-14-22-21-14), [2](https://www.trustradius.com/reviews/greenlight-guru-2021-08-02-11-09-28))

### Medical Device Compliance
Users consistently praise Greenlight Guru's capabilities in medical device compliance and regulatory standards. They highlight the platform's effectiveness in ensuring compliance with FDA regulations, ISO standards, and other industry guidelines. Reviewers appreciate how Greenlight Guru simplifies the complex process of maintaining compliance in the highly regulated medical device industry. The platform's user-friendly interface and specialized modules for design control and risk management are particularly lauded for their contribution to achieving and sustaining compliance. Additionally, users value the platform's ability to streamline quality management processes while keeping a strong focus on compliance with stringent regulatory requirements. (Source Reviews: [1](https://www.trustradius.com/reviews/greenlight-guru-2022-06-09-10-55-03), [2](https://www.trustradius.com/reviews/greenlight-guru-2022-06-16-09-47-15), [3](https://www.trustradius.com/reviews/greenlight-guru-2022-06-20-13-05-42), [4](https://www.trustradius.com/reviews/greenlight-guru-2022-06-16-10-41-21), [5](https://www.trustradius.com/reviews/greenlight-guru-2021-08-20-20-08-17), [6](https://www.trustradius.com/reviews/greenlight-guru-2021-08-06-09-49-30), [7](https://www.trustradius.com/reviews/greenlight-guru-2021-08-06-08-35-21), [8](https://www.trustradius.com/reviews/greenlight-guru-2021-08-05-15-45-17), [9](https://www.trustradius.com/reviews/greenlight-guru-2021-07-29-13-58-45), [10](https://www.trustradius.com/reviews/greenlight-guru-2021-08-02-11-09-28), [11](https://www.trustradius.com/reviews/greenlight-guru-2021-08-12-09-50-13), [12](https://www.trustradius.com/reviews/greenlight-guru-2021-08-05-09-59-47))

### Regulatory Compliance
Users consistently praise Greenlight Guru for its regulatory compliance capabilities. Reviewers highlight that Greenlight Guru excels in helping organizations maintain compliance with ISO 13485, FDA regulations, and other industry standards. The platform's ability to streamline compliance processes, such as managing change orders, DHF creation, and post-market activities, has been lauded by users. Additionally, Greenlight Guru's user-friendly interface and cloud-based system make it easy for teams to navigate and collaborate while ensuring adherence to regulatory requirements. Customers appreciate the platform's efficient workflows for documenting quality events, risk management, and maintaining DHFs in compliance with FDA regulations. Greenlight Guru's out-of-the-box validated workspace and on-demand customer service further contribute to its reputation as a reliable solution for regulatory compliance in the medical device industry. (Source Reviews: [1](https://www.trustradius.com/reviews/greenlight-guru-2022-06-16-09-47-15), [2](https://www.trustradius.com/reviews/greenlight-guru-2022-06-20-13-05-42), [3](https://www.trustradius.com/reviews/greenlight-guru-2021-08-05-15-45-17), [4](https://www.trustradius.com/reviews/greenlight-guru-2022-06-16-10-41-21), [5](https://www.trustradius.com/reviews/greenlight-guru-2021-08-06-08-35-21), [6](https://www.trustradius.com/reviews/greenlight-guru-2021-08-20-20-08-17), [7](https://www.trustradius.com/reviews/greenlight-guru-2021-08-06-09-49-30), [8](https://www.trustradius.com/reviews/greenlight-guru-2021-08-12-09-50-13), [9](https://www.trustradius.com/reviews/greenlight-guru-2021-07-29-13-58-45), [10](https://www.trustradius.com/reviews/greenlight-guru-2021-08-02-11-09-28))

### ISO Standards and FDA Regulations
Users consistently praise Greenlight Guru for its robust ISO standards and FDA regulations compliance. They highlight the platform's ability to ensure adherence to ISO 13485 and FDA requirements, making it easier to navigate audits and maintain regulatory compliance. Reviewers appreciate the streamlined design control process and the platform's effectiveness in obtaining FDA clearance efficiently. Greenlight Guru's focus on meeting ISO and FDA standards is seen as a significant advantage by users, contributing positively to their overall experience with the platform. (Source Reviews: [1](https://www.trustradius.com/reviews/greenlight-guru-2022-06-16-09-47-15), [2](https://www.trustradius.com/reviews/greenlight-guru-2022-06-16-10-41-21), [3](https://www.trustradius.com/reviews/greenlight-guru-2021-08-05-15-45-17), [4](https://www.trustradius.com/reviews/greenlight-guru-2021-08-12-09-50-13), [5](https://www.trustradius.com/reviews/greenlight-guru-2022-06-09-10-55-03), [6](https://www.trustradius.com/reviews/greenlight-guru-2021-08-06-09-49-30), [7](https://www.trustradius.com/reviews/greenlight-guru-2021-08-20-20-08-17), [8](https://www.trustradius.com/reviews/greenlight-guru-2021-07-29-13-58-45), [9](https://www.trustradius.com/reviews/greenlight-guru-2021-08-05-09-59-47), [10](https://www.trustradius.com/reviews/greenlight-guru-2021-08-02-11-09-28))

### Risk Management
Users generally praise Greenlight Guru's robust risk management capabilities. Reviewers appreciate the software's ability to streamline risk assessment processes during product development and its effectiveness in ensuring compliance with regulatory requirements. Some users have noted that Greenlight Guru's risk management functionalities have significantly improved their overall risk mitigation strategies. However, a few reviewers have expressed concerns about the software's performance in managing risks during the production and post-production phases. Despite some mixed feedback, the consensus leans towards Greenlight Guru being a valuable tool for effectively managing risks in the medical device industry. (Source Reviews: [1](https://www.trustradius.com/reviews/greenlight-guru-2022-06-09-10-55-03), [2](https://www.trustradius.com/reviews/greenlight-guru-2022-06-16-10-41-21), [3](https://www.trustradius.com/reviews/greenlight-guru-2021-08-20-20-08-17), [4](https://www.trustradius.com/reviews/greenlight-guru-2021-08-05-15-45-17), [5](https://www.trustradius.com/reviews/greenlight-guru-2021-07-29-13-58-45), [6](https://www.trustradius.com/reviews/greenlight-guru-2021-07-29-13-08-50), [7](https://www.trustradius.com/reviews/greenlight-guru-2021-08-02-11-09-28))

### Training Management
Reviewers consistently praise Greenlight Guru's training management capabilities. Users highlight the system's user-friendly interface and its ability to save time by streamlining training processes. Some reviewers mention that the training module has been a valuable addition, enhancing the overall efficiency of managing employee training within the organization. While there are occasional mentions of areas for improvement, such as the need for more customization options, the general sentiment leans towards the positive side regarding Greenlight Guru's training management features. (Source Reviews: [1](https://www.trustradius.com/reviews/greenlight-guru-2022-06-09-10-55-03), [2](https://www.trustradius.com/reviews/greenlight-guru-2022-07-14-22-21-14), [3](https://www.trustradius.com/reviews/greenlight-guru-2021-08-05-09-51-53), [4](https://www.trustradius.com/reviews/greenlight-guru-2022-06-16-10-41-21), [5](https://www.trustradius.com/reviews/greenlight-guru-2022-06-20-13-05-42), [6](https://www.trustradius.com/reviews/greenlight-guru-2021-07-29-13-58-45), [7](https://www.trustradius.com/reviews/greenlight-guru-2021-08-02-11-09-28), [8](https://www.trustradius.com/reviews/greenlight-guru-2021-08-05-15-45-17), [9](https://www.trustradius.com/reviews/greenlight-guru-2021-08-12-09-50-13), [10](https://www.trustradius.com/reviews/greenlight-guru-2021-08-05-09-59-47), [11](https://www.trustradius.com/reviews/greenlight-guru-2021-07-29-13-08-50), [12](https://www.trustradius.com/reviews/greenlight-guru-2021-08-06-08-35-21))

### Audit Management
Users generally appreciate Greenlight Guru's audit management capabilities. Reviewers highlight the efficiency and control provided by the change order function, making it easy to route and offering good visibility. The internal audit module is well-designed and user-friendly, enhancing the overall audit process. However, some users mention areas for improvement, such as the search engine for locating documents and the format consistency across different functions. Despite these minor drawbacks, Greenlight Guru's audit management features are generally well-received by users. (Source Reviews: [1](https://www.trustradius.com/reviews/greenlight-guru-2022-06-16-09-47-15), [2](https://www.trustradius.com/reviews/greenlight-guru-2022-07-14-22-21-14), [3](https://www.trustradius.com/reviews/greenlight-guru-2021-07-29-13-08-50), [4](https://www.trustradius.com/reviews/greenlight-guru-2021-08-06-09-49-30), [5](https://www.trustradius.com/reviews/greenlight-guru-2022-06-09-10-55-03), [6](https://www.trustradius.com/reviews/greenlight-guru-2021-08-12-09-50-13), [7](https://www.trustradius.com/reviews/greenlight-guru-2021-08-05-09-59-47), [8](https://www.trustradius.com/reviews/greenlight-guru-2021-08-06-08-35-21))

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.

Live Testing

Virtual Cloud

Sauce Labs

Greenlight Guru

Quality Management Software helps measure and improve the quality of a company's product, service and processes. It is often used by manufacturers and includes functionalities such as auditing, risk management, complaint management, and compliance.

Quality Management

Likelihood to Recommend

Likelihood to Renew

Design Control Spotlight: 
Documenting and managing Design Control traceability has never been easier. Perform Digital Design Reviews through flexible workflows to demonstrate compliance.

Document Management Spotlight: 
Speed up reviews and approval workflows by keeping your records and procedures organized, up-to-date, and always accessible to the right people with role-based security.

Risk Management Spotlight: 
Integrate Risk Management into all of your quality processes in a system that directly aligns with ISO 14971:2016.

Post-Market Quality Events Spotlight:
Streamline your Post-Market Quality Activities to maintain full closed-loop traceability within your QMS.

The Ultimate Guide to ISO 13485:2016 Quality Management Systems for Medical Devices

The Definitive Guide to ISO 14971 Risk Management for Medical Devices

Why Paper-Based Quality Management Systems are No Longer an Option

5 Do's and Don'ts When Choosing a QMS Solution for your Medical Device Company

How to Manage QMS Changes Regarding EU MDR, IVDR & ISO 13485:2016

Asana

Xero

Todoist

CTO (Chief Technical Officer)

Greenlight Guru 2022-06-09 10:55:03

RA/QA Assurance Specialist

Greenlight Guru 2022-06-16 09:47:15

QuickBooks Online

Odoo

CEO & Co-founder

Greenlight Guru 2021-08-20 20:08:17

Microsoft 365

Director, QA/RA

Greenlight Guru 2021-08-06 09:49:30

Veeva Vault PromoMats

AgileField

MasterControl Spark quality solution

Director of QA/RA/CA

Greenlight Guru 2021-08-06 08:35:21

TrustRadius is a technology and business research firm based in Austin, Texas. The company is known as a review platform for verified B2B technology and software reviews through a proprietary algorithm and human verification.

TrustRadius

Ability to modify

Document editing

User license

Search engine

Industry standard

One document

Additional information

Erp systems

Post production

App support

Easy to use

Customer service

Change orders

Customer feedback

User interface

Training module

Improving the platform

Platform helps

Use interface

Change management

Home

Quality Management System Software

We use Greenlight Guru for all of our Quality Management System needs, including design controls, document control, and risk management. Greenlight Guru allows us to develop our medical device products in a way that is compliant with requirements from the FDA and other regulatory bodies and is easily auditable for both internal and external audits.

Design traceability
Training management
Risk management

Occasional non-critical bugs (work isn't saved, documents load slowly, etc.)
Some processes take too many clicks.
Would love to see in-app support of more file types.

Design traceability matrix
Document control
Change orders

Saved a significant amount of consultant time.
Removed regulatory and audit risks.
Required cash and time investment.

Qualio and MasterControl Quality Excellence

Todoist: To-Do List & Task Manager, Asana, Xero

Change orders.
Analytics.
Flow charts for complaints.
Flow charts for NCR.

Documents could are hard to searched.
It does not let you embed documents phases.
Other departments can see superseded documents it should only allow the RA/QA department to see them.

Document control.
Organization.
Projects.

It's very educative.
It makes it easier for audits.
FDA compliance.

Nonconformances
Complaints
CAPAs
PD Projects
document organization

Risk management
document storage
Complaint handling
Metrics

For audits
Training
Analyzing complaints, NCRs and CAPAs

No other way. I think we selected a great system.

Greenlight Guru houses our electronic quality management system, which is essential for compliance in a highly regulated industry like medical devices. Nearly the entire organization has to use it, and it helps us streamline quality management, risk management, and design controls.

User friendly
The best customer service in the industry
Constant product updates

Some features we'd like do not get implemented, but they are not major
We'd like to see a few more integrations, especially with ERP systems

Quick and efficient customer service
Constantly expanding platform

Huge amounts of time saved
Lower potential for mistakes in a paper-based system

We utilize Greenlight Guru for document management across our entire company. The product addresses our need for a paperless system that ensures compliance with the necessary regulations and standards.

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.

Document editing must be accomplished by downloading and re-uploading.
While the software is generally intuitive, users do have to really use the software to become proficient and to take advantage of its capabilities.

Positive impact in that it was helpful during our ISO 13485 certification.

Greenlight Guru is a solution for the following: Document Management, Change Orders, DHF Creation, Traceability, Post market including customer feedback, audits, CAPAs, non-conformances. It is our source of truth for everything related to full lifecycle development of our products from concept to post-commercialization, complying to the applicable 21 CFR Part 11.

Greenlight Guru

Overview

What is Greenlight Guru?