Audiment vs Greenlight Guru

Built for physical frontline store inspections: kitchen hygiene, refrigerator temperatures, visual merchandising, service speed, and cashier protocols across distributed commercial locations.

Built exclusively for medical device compliance: Design Controls, Risk Management (ISO 14971), Design History Files (DHF), and FDA 21 CFR Part 820 regulatory audits.

Used by frontline shift supervisors, store managers, and regional coaches on personal smartphones (BYOD) walking physical store aisles.

Used by biomedical engineers, regulatory affairs specialists, and clinical quality managers working at desktop computers documenting medical device specifications.

Photo evidence is captured strictly through an in-app live camera modal with front/rear flip and orientation correction. Device gallery uploads are restricted by default, preventing staff from submitting pre-saved or stock photos.

Evidence collection centers on clinical trial test results, medical device engineering schematics, verification/validation (V&V) protocols, and FDA submission documents.

Enforces high-accuracy GPS geolocation capture directly at final submission. If coordinates cannot be verified on-site within an 8-second window, submission is strictly blocked until physical presence is confirmed.

Operates as a desktop cloud eQMS; physical presence verification and GPS geofencing are completely irrelevant to medical device design controls.

Critical store failures automatically generate a tracked CAPA document with a strict 48-hour SLA assigned to the store manager, backed by proactive 6-hour cron reminders and photo-verified closure.

Quality non-conformances trigger formal FDA-regulated CAPA investigations requiring clinical risk evaluations and formal regulatory reporting.

Supports surprise audits (suppressing manager pre-notifications) and 'Flashmob' mass-dispatches with custom hourly deadlines to verify promotional rollouts or sudden operational issues across all stores.

Audits are formal internal quality audits or FDA notified-body inspections planned months in advance.

Dashboards provide cross-branch benchmark rankings, regional performance trends, and automated trend alert banners (flagging locations that score below threshold on 3+ consecutive audits) to surface systemic drift instantly.

Dashboards visualize medical device design traceability matrices, open CAPAs, change orders, and ISO 13485 audit readiness.

Flat per-location pricing with unlimited users per branch. Shift managers, assistant store leads, head chefs, and regional coaches all have dedicated accounts without driving up monthly software licensing bills.

Specialized MedTech pricing typically starting at $15,000 to $50,000+ per year based on medical device engineering seats and compliance modules.

100% cloud-and-mobile responsive web app/PWA. Runs on any smartphone browser instantly via web link without requiring App Store downloads, MDM provisioning, or personal storage consumption.

Desktop web portal optimized for medical device engineers managing complex multi-level design traceability matrices.

Audits continue fully offline without interruption. You can capture live camera photos, complete logic-based checks, and the system syncs automatically in the background once the device reconnects to Wi-Fi or cellular.

Requires desktop internet connectivity for cloud eQMS database updates.

Built for store floors, not medical device clinical engineering

Greenlight Guru is built for biomedical engineers submitting 510(k) applications to the FDA. Audiment is built for operations teams inspecting store floors, kitchen hygiene, and brand standards on smartphones.

48-hour automated CAPA SLAs

Store operational defects cannot wait for clinical regulatory reviews. Audiment automatically triggers 48-hour SLA tasks with photo verification to fix store issues immediately.

Fraction of the cost for physical store networks

Audiment offers flat per-location pricing with unlimited frontline users, delivering immediate operational ROI without expensive MedTech eQMS software commitments.

Medical device design controls and FDA 21 CFR Part 820

If you are a medical device manufacturer designing surgical instruments, diagnostic equipment, or Software as a Medical Device (SaMD) requiring FDA 21 CFR Part 820 and ISO 13485 compliance, Greenlight Guru is an extraordinary, dedicated MedTech platform.