Medical device quality management software

Track every document in a single, validated system.
Poor document management leads to mistakes and audit findings. Greenlight Guru makes reviews,
approvals, and version control simple. The QMS software centralizes controlled documents in a validated eQMS software platform, making reviews, approvals, version control, and audit trails easier to manage as part of a connected quality management system.

Track every change, automatically.
From version history to approvals to downstream training, every action is logged and linked
without gaps or manual effort.

Work in tools your teams already uses
Create, edit, and co-author controlled documents in Google Docs and Microsoft Office for Web,
while maintaining full document control, versioning, and approvals within Greenlight Guru.

Save time with smart workflows
Edit documents in-line, schedule periodic reviews, and keep approvals moving with built-in
reminders that eliminate follow-up.

Control every update without slowing your team down.
Greenlight Guru makes updates visible, reviewable, and fully traceable from the moment a change is requested through approval and implementation. Every change is evaluated for risk, training, and downstream impact with built-in promptsthat prevent missed steps.

Catch issues before they spread.
Connected records show what’s affected and what needs attention, from SOPs to specs to
training requirements.

Save time with guided routing.
Route updates through the right reviewers, compare old and new versions side by side,
and track every approval in one place.

Keep your team trained without chasing them down.
Our integrated training management solution lets you easily assign and track
training to ensure your team is up-to-date on current procedures, quality processes, and required compliance standards.

Assign training for anything, no workarounds required
Tie training to document updates with built-in policies for roles, teams, and events
like new hires, or assign standalone training as needed.

See exactly where things stand
Track completions by person, team, or document so you always know who’s
trained, what’s overdue, and what still needs to happen.

Save hours with background compliance
Greenlight Guru routes assignments, logs completions, and handles validation
behind the scenes.

Stay in control as your supplier list scales.
Greenlight Guru applies the right oversight automatically, so your supply chain
stays clean and compliant.

Enforce controls by risk level.
Set supplier types and risk once. The system auto-applies required docs,
approvals, and monitoring.

Keep every supplier compliant.
New entries follow your defined process automatically, no extra QA policing.
required.

Save time with built-in oversight
Export reports, automate reminders, and skip the manual
tracking during audits.

Supplier evaluation tied to risk and quality records
Connect supplier evaluation to quality records: Evaluate suppliers by risk, documentation, qualification status, audit history, quality events, and performance. Link supplier issues to CAPA, nonconformance, parts, BOMs, and audit records as the business scales.

Close issues faster with a connected system.
Manage all your quality events in one place, including CAPAs, complaints, and other quality records, so you can close them out faster.

Configure workflows to fit your process.
Start from best-practice templates or fully tailor event types, stages, questions,
and required fields as your team evolves. Use connected workflows to evaluate each customer complaint, link it to affected products or documents, and determine whether it requires escalation, CAPA, or additional investigation.

Link issues to what matters
Every event ties directly to affected products, documents, and changes, giving
you a complete quality record without digging.

Route and sign off without delays
Assign tasks, route reviews in parallel or sequence, and sign digitally with 21 CFR
Part 11-compliant approvals built into the flow.

Track every part and revision
Track every part to ensure you have a complete, connected view of your product
from end to end.

Centralize your parts
Define part types and use automated, custom IDs to create a single source of
truth for all your parts.

Control every change
Automatically manage part revisions through a built-in change control workflow,
with full version tracking and approval history.

Build your BOM
Organize parts into hierarchies to reflect your Bill of Materials (BOM) and instantly see
where a part is used across all products.

Maintain a dynamic, paperless Risk Management File
Streamline risk reviews and trace documentation throughout your design and
development process to easily maintain an audit-ready Risk Management File.

Stay compliant with ISO 14971:2019.
Be confident in your compliance with software designed in accordance with
the latest standard in medical device risk management and connected to the broader quality processes in your QMS.

Unite risk management and design controls 
Integrate your risk management and design processes by linking design
controls and documents as risk control measures. 

Build your risk acceptability matrix
Ensure consistent classification of risk across the risk project and evaluate risk
levels based on your set criteria.

Support risk-based thinking from planning to production
Support risk-based quality planning: Keep the records that support FMEA, Control Plans, SPC, APQP, supplier controls, approvals, changes, CAPAs, and risk management connected so teams can see how manufacturing and product decisions affect quality and compliance.

Resolve issues quickly with full traceability.
Capture and manage CAPAs, nonconformances, and corrective and preventive actions in one place, with linked
documentation, assigned tasks, and real-time tracking to quickly address root causes.

Keep your CAPAs on track
Use a dedicated CAPA workflow to set tasks and monitor deadlines as you progress
through investigation, analysis, and verification.

Eliminate data silos
Avoid the human error that comes with spreadsheets and binders by housing all your
CAPA and nonconformance data and documentation in a single system.

Move from reactive fixes to proactive resolution.
Close out CAPAs quickly, find trends in nonconformances, and generate audit-ready
documentation that supports stronger quality management across your organization.

Take the pain out of audits.
62% of teams spend more time prepping for audits than working to improve quality.
Greenlight Guru lets you run internal audits or supplier audits directly from your QMS, with findings, evidence, actions, and audit trails connected in one place. 

Keep all your audit prep in view
Track findings, assign actions, and keep all your evidence in one place so you can always
show a clear, continuous record of compliance.

Schedule and automate audit activities
Set planned quality audits as needed and then manage them with reminders and
notifications to keep everyone on track.

Manage retraining and updates
Post-audit, schedule retraining and get visibility into events and completion tracking to
keep your training program compliant.

Run internal audits, supplier audits, and compliance audits from one QMS
Plan audit programs, schedule internal audits, manage supplier audits, assign findings, track corrective actions, and keep objective evidence connected to the records auditors need to see. Greenlight Guru helps teams connect audit findings to CAPA, training, supplier evaluation, document updates, quality events, and compliance requirements, so audit prep becomes a continuous process rather than a last-minute scramble.

Automatically build a living DDF
Link user needs, inputs, outputs, verifications, and validations automatically to create a
dynamic DDF that stays audit-ready from day one.

Link as you work
Add requirements, connect risks, and flag verifications without leaving the workspace or
interrupting your team’s flow.

Flag traceability gaps before they become blockers
AI checks your requirements for verifiability, while real-time trace graphs expose missing
links across design, risk, and test.

Stay audit-ready at all times
Every element is versioned, reviewable, and export-ready, so you’re always ready for
inspections, without scrambling.