Quality isn’t slowing you down. Your QMS is.

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.

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

Keep teams aligned in real time
Ensure everyone is working with the latest version with a single document flow for updates,
reviews, approvals, and training.

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
they happen.

Close the loop automatically
Every change is evaluated for risk, training, and downstream impact with built-in prompts
that 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.

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.

Close issues faster with a connected system
Manage all your quality events in one place, so you can close them out faster and
stay inspection-ready.

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.

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.

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.

Resolve issues quickly with full traceability
Capture and manage CAPAs and nonconformances 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 to stay ahead of potential issues.

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 or supplier audits directly from your QMS. 

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.

Automatically build a living DHF
Link user needs, inputs, outputs, verifications, and validations automatically to create a
dynamic DHF 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.