Be Audit Ready at a
Moment’s Notice

Greenlight Guru provides a connected quality ecosystem where every record of your QMS is organized, centralized, and traceable. Be ready for any type of audit, at any time with full confidence (and some peace of mind). Consider us an extension of your team — we’re here to help.

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Having audit processes in place and teams trained on those processes is essential for long-term success. Internal audits, external audits, supplier audits, FDA audits—the list goes on. Avoid overcomplicating these processes. Leverage an easy to use, task-based, organized, and seamless solution.

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

Take the Anxiety Out of Audits

We know audits are a necessary yet stressful part of our industry. Greenlight Guru is here to help drive a positive audit experience every time. We will also be there to celebrate your successes with you.

Lead With Confidence

Successful audits are a competitive advantage and should be treated as such. When you’re confident your system is compliant, you’re already ahead.

Centralize Your Source of Truth

Audits don’t have to be complicated. Say goodbye to piles of paperwork and hours in your audit war room. Have full visibility and traceability into any document you may need and even ones you may have initially missed.

Embrace Every Audit

Be ready for all audits— even remote ones. Our cloud-based system ensures the challenges of paper-based audits are in the past and that everything you could possibly need is only a few clicks away.

Being Compliant is Key

Whether its ISO 13485, ISO 14971, 21 CFR Part 11, 21 CFR Part 820, EU MDR or another one of the many acronyms — our workflows ensure your processes adhere to the industry’s requirements and best practices.

Conduct Audits With Ease

We are here to alleviate common audit anxieties so you can focus on building compliant life-changing medical technologies.

Eliminate Inefficiencies With Automated Processes

With custom workflow templates created by your company, it's simple to incorporate specific, detailed steps while following your company's protocol to automate the process.

Keep a single, up-to-date workflow with management controls in place for your audit process. Automate your workflow inside your QMS to help you track the correct action items to the right user or group - increasing your team's efficiency and reducing the need for additional resources.

Teamwork Makes the Audit Dream Work

Assign audit-related tasks to your team and track everyone’s progress towards due dates. Manage tasks, follow-ups, communications, and any actions that result from audit findings. Escalate high-risk findings for investigation and monitor low-risk findings for recurrence. Access your audit artifacts and provide them to the auditor in a few clicks with absolute confidence that nothing has changed. Compliance is a team sport — put Greenlight Guru on your roster.

Many Inputs, One Source of Truth

Tie the procedures, the tasks, and all audit information into a single workflow. Create a single audit report so all the data is accessible in one single document.

Ensure full traceability and auditability throughout as you easily view what was changed, why it was changed, when it changed, who changed it, and what was impacted due to an audit. You can cure audit headaches with one click.

Built for Customers Like You

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Greenlight Guru has been instrumental in helping us efficiently navigate the Quality Management System process and develop our FDA Submission.

Ryan Nolan Co-Founder / VP of Clinical Operations Photonicare

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Greenlight Guru was instrumental in implementing our Quality System. With them, we can bring safer, higher-quality medical devices to success while maintaining a Quality Culture throughout our entire device lifecycle.

Maxime Rochan Director of Quality Puzzle Medical

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Greenlight Guru has differentiated us from other start-ups. Our auditors told us, "Wow, you're steps ahead of anyone else."

Amy Papranec VP of Clinical Operations Critical Care Diagnostics, Inc.

Greenlight Guru has been instrumental in helping us efficiently navigate the Quality Management System process and develop our FDA Submission.

Ryan Nolan Co-Founder / VP of Clinical Operations Photonicare

Maxime Rochan Director of Quality Puzzle Medical

Greenlight Guru has differentiated us from other start-ups. Our auditors told us, "Wow, you're steps ahead of anyone else."

Amy Papranec VP of Clinical Operations Critical Care Diagnostics, Inc.

Don’t Leave Audits up to Chance

Don’t let the fear of fines, penalties, and product recalls keep you up at night. With Greenlight Guru, you can be audit-ready at any moment, which means more life-changing products in the market faster.

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Ultimate Guide to Comparing Quality Management System Solutions

Be Audit Ready at a Moment’s Notice

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

Take the Anxiety Out of Audits

We know audits are a necessary yet stressful part of our industry. Greenlight Guru is here to help drive a positive audit experience every time. We will also be there to celebrate your successes with you.

Conduct Audits With Ease

Eliminate Inefficiencies With Automated Processes

Start Now, Succeed Later

Teamwork Makes the Audit Dream Work

Many Inputs, One Source of Truth

Eliminate Inefficiencies With Automated Processes

Start Now, Succeed Later

Teamwork Makes the Audit Dream Work

Many Inputs, One Source of Truth

Built for Customers Like You

Don’t Leave Audits up to Chance

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Be Audit Ready at a
Moment’s Notice

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