CompareSimplerQMS vs TrackWise Digital
from $17.5k/yr
Minimum $17,500 a year covers up to 15 users
Choose it if: You run a small or mid-sized device or pharma company, write your SOPs in Microsoft Word, and want implementation, validation and training included in one yearly price.
Watch out: Design controls, risk and software lifecycle are managed as documents with no native traceability, and contracts auto-renew with a 90-day notice period and a 5% yearly price rise.
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.
| SimplerQMS 7.1 | TrackWise Digital 5.2 | |
|---|---|---|
| Price and buying | ||
| AffordabilityHow we score affordabilityEstimated yearly cost for a 10-person team, including required fees. | 7.0 from $17.5k/yr Minimum $17,500 a year covers up to 15 users | 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. | 6.0 Starting price only Services included; licence prices 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. | 7.0 Free trial Guided trial after a call; interactive tours | 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 Auto-renews, 90-day notice; export to Excel/CSV plus files | 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. | 8.0 EU or US, selectable Public DPA; no current 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. | 7.0 Fixed 5% increase every January Starter entry price up 27% since 2024 (now covers 15 users) | 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. | 8.0 Validation package and ISO 27001; no UDI or eMDR 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. | 3.5 Design, risk and software files are documents; no trace links | 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 4.3 / 5 on Capterra 36 reviews | 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 4.9 / 5 on Capterra 36 reviews | 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 4.5/5 on Capterra (36 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. | 7.0 5–8 weeks Vendor pages say 5–6, about 6 or 6–8 weeks; templates included | 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
| SimplerQMS | TrackWise Digital | |
|---|---|---|
| Built-in document editor | NoDocuments are written in Microsoft Office, not in a built-in editor | Not confirmed yetReview and annotation in the system; no documentation of a built-in editor |
| Edit in Word or Google Docs | YesWord, Excel and PowerPoint via Microsoft 365 and a Word add-in; Microsoft 365 licences required | Not confirmed yetNo Word or Google Docs integration documented |
| SOP templates included | YesISO 13485 and 21 CFR 820 template packages included | Partly or add-onPre-configured, pre-validated quality processes; no SOP set |
| Jira or Git integration | Partly or add-onJira named on marketing pages; no documented integration | Not confirmed yetNo Jira or Git integration found |
| IEC 62304 software features | Not confirmed yetOnly a generic 'supports alignment with IEC 62304' claim | Not confirmed yetNo IEC 62304 features found |
| Validation package included | YesValidation plan, report and IQ/OQ/PQ included; revalidated each release | YesPre-validated processes; validation information in the customer portal |
| Public API | Partly or add-onAPI stated and API keys in admin settings; no public documentation | YesSalesforce platform APIs |
| Single sign-on (SSO) | YesMicrosoft Entra ID and Google Workspace on all licence types | Not confirmed yetNot documented by the vendor |
| Supplier portal | Not confirmed yetNo supplier portal found | YesSuppliers answer audit findings and corrective actions in a portal |
| Training with quizzes | YesMultiple-choice quizzes with a quiz report | YesTests and assessments in training management |
| FDA MDR or EU vigilance reporting | Partly or add-onVigilance reportability assessment; reports filed outside the system | Partly or add-onFDA eMDR submission documented; EU MIR only named on a marketing page |
| AI features | YesAI-generated change summaries when sending documents for approval | 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.