Design Control Software

THE MOST POWERFUL DESIGN CONTROL MATRIX.

With Greenlight Guru because you're able to create your design control objects, link complex configurations and attach related docements with a single click now you can update your trace matrix in minutes, not hours or days.


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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.

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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 at any time.

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.

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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.

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GREENLIGHT GURU IS THE ONLY QUALITY MANAGEMENT SOFTWARE DESIGNED SPECIFICALLY FOR THE MEDICAL DEVICE INDUSTRY.

Want to learn more about our Premarket Quality Management software? Let us show you around Greenlight Go.

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