CompareQualio vs TrackWise Digital
est. $12–30k/yr
Estimate from 2019–2021 list prices; implementation fee extra
Choose it if: You're a growing device or combined device-and-pharma company that wants a QMS your whole team will actually use, with design controls linked to Jira and data hosted in the EU.
Watch out: Prices aren't published, every plan carries an implementation fee, and complaint handling, vigilance reporting and production records aren't dedicated features.
on request
AppExchange listing: from $200 per user per month (2022)
Choose it if: You run quality for a larger device, diagnostics or combined device-and-pharma company and want proven complaint, CAPA, eMDR and risk workflows on a validated cloud platform.
Watch out: Prices and hosting region aren't published, there are no design controls, and the contract renews for 36 months unless you give notice.
| Qualio 6.8 | TrackWise Digital 5.2 | |
|---|---|---|
| Price and buying | ||
| AffordabilityHow we score affordabilityEstimated yearly cost for a 10-person team, including required fees. | 5.5 est. $12–30k/yr Estimate from 2019–2021 list prices; implementation fee extra | 4.0 on request AppExchange listing: from $200 per user per month (2022) |
| Price transparencyHow we score price transparencyWhether the vendor publishes its prices on its own website. | 2.0 No public prices Published until 2021; implementation fee not published | 1.0 No public price Never published on the vendor's site |
| Try before you buyHow we score try before you buyWhether you can try the product yourself before talking to sales. | 5.0 No free trial Interactive tour and live demo | 5.0 No free trial Recorded demos behind a form; live demo |
| Contract and lock-inHow we score contract and lock-inMinimum term, whether you can take all your data with you at no extra cost, and other lock-in risks. | 8.0 Annual Terms defer to the order form; pricing page says annual. Export in PDF, XLSX and CSV; public API | 4.0 Term set per order Renews for 36 months by default; CSV export on request |
| EU data residencyHow we score eu data residencyWhether your data can be hosted in the EU, and how clearly that's documented. | 10.0 EU (Dublin) Public DPA and subprocessor list | 3.0 Not stated Salesforce and AWS; DPA on request; SCCs in the terms |
| Budget predictabilityHow we score budget predictabilityHow well you can predict future bills: price-increase clauses, price history and the cost of adding users. | 5.0 Renewal increases not capped No list prices since 2021; one user reports a hike | 7.0 No renewal-price clause No list prices ever published; no hike reports found |
| Product | ||
| Compliance coverageHow we score compliance coverageHow much of ISO 13485, FDA and EU MDR the system covers out of the box, based on its documentation. | 7.0 No UDI or vigilance reporting features found | 8.0 SOC 2 Type II; pre-validated processes |
| Design controls and traceabilityHow we score design controls and traceabilityHow well requirements, risks, tests and software lifecycle are linked, and whether the design history file is generated for you. | 9.0 Trace matrix generation; Jira included | 2.5 ISO 14971 risk module; no design controls found |
| UsabilityHow we score usabilityEase-of-use ratings from G2 or Capterra, adjusted for what users repeatedly report. | 8.0 9.0 / 10 on G2 663 ratings | 8.0 3.9 / 5 on Capterra Ease of use, 15 reviews; capped at 8 (review drive) |
| Service | ||
| Support and onboardingHow we score support and onboardingSupport ratings from review sites, plus whether onboarding help is included in the price. | 8.0 9.1 / 10 on G2 561 ratings | 8.0 4.1 / 5 on Capterra Customer service, 15 reviews; implementation included in QuickTrack; capped at 8 (review drive) |
| Community sentimentHow we score community sentimentOverall review-site rating, adjusted for what independent users say in communities. | 8.0 4.4/5 on G2 (781 reviews) | 8.0 4.3/5 on Capterra (15 reviews); capped at 8 (review drive) |
| Time to go liveHow we score time to go liveHow long it usually takes until your team can work in the system, and whether templates are included. | 6.0 30–60 days Vendor estimate; 8-week onboarding; templates extra | 4.0 3–6 months Vendor case studies; no SOP templates |
Scores are out of 10. The better side of each row is highlighted. How we score
| Qualio | TrackWise Digital | |
|---|---|---|
| Built-in document editor | YesIn-app editor with co-editing; users report weaker formatting than Word | Not confirmed yetReview and annotation in the system; no documentation of a built-in editor |
| Edit in Word or Google Docs | Partly or add-onWord via OneDrive integration; Google Docs must be converted | Not confirmed yetNo Word or Google Docs integration documented |
| SOP templates included | NoSOP templates are a paid add-on (Content Pathways) | Partly or add-onPre-configured, pre-validated quality processes; no SOP set |
| Jira or Git integration | YesJira included; GitHub, GitLab, Azure DevOps via add-on | Not confirmed yetNo Jira or Git integration found |
| IEC 62304 software features | Not confirmed yetNo IEC 62304-specific features documented | Not confirmed yetNo IEC 62304 features found |
| Validation package included | YesCSA validation pack per release; cost not stated | YesPre-validated processes; validation information in the customer portal |
| Public API | YesREST API with developer portal, Growth plan only | YesSalesforce platform APIs |
| Single sign-on (SSO) | YesEntra ID, Google and Okta | Not confirmed yetNot documented by the vendor |
| Supplier portal | Not confirmed yetNo external supplier portal found | YesSuppliers answer audit findings and corrective actions in a portal |
| Training with quizzes | YesMultiple-choice assessments, 100% to pass | YesTests and assessments in training management |
| FDA MDR or EU vigilance reporting | Not confirmed yetNo FDA MDR or EU vigilance reporting found | Partly or add-onFDA eMDR submission documented; EU MIR only named on a marketing page |
| AI features | YesAI gap analysis; AI Copilot in closed beta | YesAuto-summarization, auto-categorization, CAPA-Advisor; separate AI terms |
We haven't written a verdict for this pair yet. The comparison above comes from our research on each system; the full reviews explain each score.