Design Control Software

A hassle-free way to document design controls and maintain full traceability

Whether an audit revealed documentation issues or you want to take preventative measures,
Greenlight Guru makes for painless compliance to ISO requirements and FDA regulations.


The Most Powerful Traceability Matrix

Create and update your traceability matrix in minutes, not hours or days.

With Greenlight Guru, you can create your design control objects, link complex configurations, and attach related documents with a single click. Wasting employee hours and paying expensive consultants for low value activities is no longer required.

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Stay Audit Ready

Provide auditors and inspectors with the signatures and objective evidence they require - on-demand.

No more chasing down lost or missing records. They leave impressed, you bring the audit to a close and you don’t walk away with observations, 483s or warning letter.


Produce On Demand Design History Files (DHF)

Stop wasting time searching for the required documentation when trying to compile your DHF.

With Greenlight Guru, you can produce all of the documents needed at each stage of production and generate your DHF immediately.

Keep Your Team on the Same Page

Provide your team a centralized workspace.

Push your product forward and meet aggressive deadlines by providing a centralized workspace where everyone can see each other’s updates in real time. Now, your team can stop wasting time chasing signatures, searching through multiple email threads and dealing with messy design transfers.


Eliminate Non-Value Adding Activities

Streamline and even automate the management of reports, matrices and other documentation needed to develop your product and prove regulatory compliance.

When you manage these activities manually, you spend thousands of dollars on consultants you don’t need, your employees waste time on these low-value activities and you slow your time to market.

Accelerate Reviews and Approvals

Electronically review and approve your design and development process at appropriate stages.

Part 11 compliant e-signatures, automated routing, approvals and full revision control make it easy to get the right info in front of the right stakeholders.


Everything you need to document design controls with full traceability

FDA/ISO Best Practices
Traceability Matrix
Manage Product Requirements
Automatically Link Design Artifacts
Electronic Sign-Offs
Design Reviews
Complete Audit Trail
Design History Files (DHF)
Controlled Sharing
Analytics & Reporting
Collaborative Workspace
Email Notifications
Revision Control
V&V Testing
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Customer References

"...great traceability matrix..."

“The traceability matrix was a huge selling point since I was in the process of trying to train my team on design controls and they had generated spreadsheets that were extremely impenetrable.”

-Michelle Zwernemann Director of Product Development Infinite Biomedical Technologies

" helps us in completing DHF..."

“Our company president was frustrated about our CAPAs. He decided Greenlight Guru would help us in completing DHF, close CAPA and handle complaints effectively.”

-Divya Mavalli Quality & Document Control Associate Medical Device Resource Corp

"...the right tool for the job..."

“We dug deeper to see how other friends we knew were handling their QMS needs and after adding up time, consultant fees, etc. we felt Greenlight Guru was the right tool for the job.”

-Gabriel Sanchez CEO Zebra Medical Technologies

Speak with a medical device quality management expert and see
Greenlight Guru in action.

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