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Platform
The Greenlight Guru Platform

Solutions built for medical device teams to move faster, stay compliant, and grow with confidence.

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Quality Management

Manage quality events, training, and documentation in one place.

Document Management

Control documents, training, and change with traceability.

Quality Events

Track CAPAs, audits, and NCs with audit-ready records.

Suppliers & Operations

Qualify suppliers and manage parts with visibility.

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Product Development

Connect design, risk, and AI-powered traceability as you build.

Requirements Management

Link needs, requirements, and verification to design controls.

Software Release Management

Automate traceability from dev tools for faster releases.

Risk Management

Assess ISO 14971 risk as requirements and tests evolve.

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Clinical Evidence

Oversee studies with connected data, documents, and workflows.

Clinical Trials

Capture compliant clinical data with a validated medical EDC.

PMCF

Plan and manage PMCF aligned to EU MDR expectations.

ePRO/eCOA

Collect clinical outcome data in-person or remotely on any device.

Why Greenlight Guru
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Medical Device Expertise

Built with regulatory insight to help medtech teams move faster with confidence.

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AI, Data, Intelligence

Find issues faster and make smarter decisions with less manual work.
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Learning, Templates. Training

Tools and resources that help teams implement quickly and meet requirements.
Solutions
Customers
Partners
Company
Resources
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QMSR is here! Is your quality system ready?

This page is your one-stop resource for understanding what’s changing, what’s at stake, and how to stay compliant.

View Now
Pricing
Contact Sales Get a Demo
Contact Sales
Get a Demo

CAPA Management Software

CAPA Software That Never Lets a Step Slip

Greenlight Guru's CAPA software for medical devices helps medtech companies effectively manage CAPAs. Log an issue, investigate the root cause, and implement and verify corrective actions, all in the same system your team uses for design, risk, supplier management, and more. Stop reacting and start planning: automate your CAPA process and build the workflows your team actually uses.

Get a Demo

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 chance of recurrence rises. Weak root cause work is the usual reason: the corrective action treats the symptom and the same finding comes back at the next audit. CAPA software that facilitates the process, from investigation through root cause analysis to verification and the effectiveness check, turns one-off firefighting into continuous improvement. Visibility across CAPA work should not be a blocker.

CAPA Software Inside Your QMS, Not a Separate Tool

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.

Automate Your CAPA Workflow Without Adding Steps

Our CAPA software is built for the medical device industry, and is designed to take steps out of the process rather than add them.

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

A CAPA that stalls may cost more than the issue that caused it. Greenlight Guru gives product, quality and management teams one view of every open CAPA, with the detail each of them needs.

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

A CAPA that stalls may cost more than the issue that caused it. Greenlight Guru gives product, quality and management teams one view of every open CAPA, with the detail each of them needs.

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 the Gaps in Your CAPA Program

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 Therapeutics 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.

Get a Demo

$ 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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