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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Training Management Product Development Design Control Risk Management CAPA Management Audit Management Supplier Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Ultimate Guide to Comparing Quality Management System Solutions

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

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CAPA Management Software

Never Miss a Step With Greenlight Guru’s CAPA Solution

Effectively manage CAPAs by collecting data, documents, design components, and other quality events living in your QMS. Stop reacting and start proactively planning. Discover how you can automate your CAPA process and create custom workflows that best suit you.

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1,100+ of the world’s leading MedTech companies trust Greenlight Guru.

CAPA-1

Unresolved CAPAs Can Become Expensive and Harmful

If a CAPA is not investigated thoroughly, the chances of recurrence rise. Collaborating with visibility on CAPA work shouldn’t be a blocker. Why put so much at stake? Invest in CAPA management that guides you through a step-by-step, traceable, compliant, and thorough workflow of correcting and preventing the issue the first time.

A CAPA Solution Fully Integrated With Your QMS

Greenlight Guru was built to guide you through your CAPAs with detail, visibility, traceability, and compliance in mind.

Complete Traceability

All data and documentation living in Greenlight Guru can be linked throughout all stages of your CAPA.

Collaborate Across Teams

Create your CAPA team. Then assign tasks to appropriate team members with deadlines as you progress through investigations, analysis, and verification.

Mitigate Risk

When the process is laid out before you, risk is reduced and the chance of a systemic problem recurring decreases significantly.

Eliminate Data Silos

All of your data and documentation related to a CAPA is housed in one single source of truth within your CAPA project. No more switching between spreadsheets and binders to get the information you need.

CAPAs Don’t Have To Feel Like A Burden

Our CAPA solution is easy to use and designed specifically for the MedTech industry.

Easily Assign Action Items

Assign tasks and keep track of progress at any time.

Automate Your Processes

Create and use custom workflow templates to become more efficient.

Review and Verify Your Work

Get your CAPA team involved with the review and final verifications needed to close it out.

Streamline Documentation Needs

Auto-generate essential documentation for alignment or when an auditor comes knocking.
Designed With Your Entire Organization in Mind

Benefits for Teams

CAPAs can become a huge setback if not dealt with effectively. We created this solution to make sure you wouldn’t miss a step.

For Product Teams

Collaborate to correct and prevent systemic problems

  • Play an essential part in determining root cause
  • Direct investigative studies
  • See the long term benefits of your CAPA work
Designed With Your Entire Organization in Mind

Benefits for Teams

CAPAs can become a huge setback if not dealt with effectively. We created this solution to make sure you wouldn’t miss a step.

For Quality Teams

Have confidence that your CAPA meets requirements

  • Get ahead of large-scale harmful problems
  • Define and implement a CAPA process early on
  • Gain visibility into the quality issues affecting your product lines

For Executive Teams

Support problem solving while growing business

  • Serve as a key player in major CAPA decisions
  • Keep your technologies on the market with confidence
  • Spend less time and money down the road
Automate CAPA

Close Gaps in CAPA Competence

Our industry benchmark survey discovered only 17% of MedTech companies feel they have achieved excellence in their CAPA processes. Don’t settle for less. Leverage Greenlight Guru’s medical device experts and deepen your team’s understanding of how to establish excellent CAPA practices.

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What Our Customers Are Saying

★ ★ ★ ★ ★

Read In-Depth Reviews Here.

“Purchasing Greenlight Guru was the best decision for our needs. Their easy-to-use eQMS, SOP Templates, and expert Guru guidance were key to us being able to successfully navigate all of our audits this year”
Amanda Feddersen
QA Manager, Monitored Therapuetics Inc.
“There are a lot of dependencies that occur in every part of a quality system. Greenlight Guru is a fantastic software because it addresses each one.”
Morris Sherwood
Regulatory Compliance, Zyris
“Greenlight Guru's Design Controls module is powerful and the traceability present across the entire QMS is my favorite part about the software. It makes remote collaboration so much more effective.”
Crystal Womack
Quality Manager, Avenda House

Experience More of Greenlight Guru’s CAPA Management

Dive further into the different stages of CAPA and see the traceability within the workspace firsthand.

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$ 125 k

saved on average per project

3

months faster to market

402

hours saved on low value-added activities

Frequently Asked Questions

How does Greenlight Guru support FDA and ISO 13485 CAPA requirements?

Greenlight Guru is built specifically to meet the requirements of 21 CFR Part 820 and ISO 13485. The software guides you through every phase of the CAPA process, including identification, investigation, root cause analysis, implementation, and effectiveness checks with structured workflows and full visibility.

Can Greenlight Guru generate audit-ready CAPA documentation?

Yes. Every CAPA event in the system is fully traceable and linked to relevant quality events, documents, and design elements, making it easy to produce audit-ready records when needed.

Does Greenlight Guru log CAPA activity with time stamps and user details?

Yes. Every action within a CAPA record is logged with a time stamp and user name, creating a complete and secure audit trail for accountability and traceability.

How does Greenlight Guru prevent duplicate or recurring CAPAs?

Greenlight Guru encourages strong root cause analysis and links related quality events across your QMS. This helps your team address systemic issues and reduce the chance of creating duplicate or repeated CAPAs.

What sets Greenlight Guru apart from other CAPA management software systems?

Greenlight Guru is purpose-built for medical device companies and connects CAPAs to your entire quality system. With built-in workflows and audit-ready records, it helps you resolve issues faster and stay compliant.
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