Qualityze review

About the price: No public price list (Sep 2026). The AppExchange listing gives $30 per user per month for the lowest licence type; modules, users, sites and services set the quote. Implementation and validation packages included, per the vendor.

What is Qualityze?

Qualityze is an enterprise quality management system from Qualityze Inc., a company founded in 2015 and headquartered in Tampa, Florida. It has offices in the UK and in Bengaluru, India.¹² It has about 100 staff and ranked No. 2586 on the 2024 Inc. 5000 list of fast-growing US companies.³²

The product is built on Salesforce and has been on the Salesforce AppExchange since 2016.³⁴ It covers quality, EHS (environment, health and safety), supplier and asset management. It is sold as separate modules for document control, CAPA, complaints, audits, supplier quality, calibration, electronic batch records and more.⁴⁵ Qualityze sells to “Lifesciences and Manufacturing” and has pages for more than 30 industries, from medical devices to oil and gas.⁵ Medical device customers include ZimVie, Highridge Medical and Medimaps.⁶⁴

Who Qualityze is for

Qualityze fits device makers, or companies that make both devices and drugs, with manufacturing and post-market work to run across several sites. It also suits teams that already use Salesforce. Named customers include ZimVie with 750 licences and an industrial company with 311 users.⁶⁷ Customers can start with a single module, such as document control or CAPA.¹

Look elsewhere if you:

• Build software or need design controls now. Design Control and FMEA are new tools in Release 17.0. In June 2026 that release was still “in progress” and targeted for Q3.⁸ The IEC 62304 support on the medical device page is a marketing claim without detail.⁹
• Are a small team preparing for a first certification. We found no SOP templates. Reviewers describe implementation projects lasting weeks to months, and some Capterra reviewers call it expensive for small businesses.¹⁰⁴
• Need EU hosting on paper. The vendor doesn’t say where customer data is hosted.¹¹¹²

Qualityze pricing

Qualityze publishes no prices on its website (checked 30 September 2026).¹ Pricing depends on the modules, users, sites and services you choose, and you get a tailored quote.¹ The vendor says:¹

• guided onboarding and implementation are part of every quote;
• validation packages come with every update at no extra fee;
• there are no per-record fees;
• you don’t need your own Salesforce licences.

The only public figure is on Qualityze’s AppExchange listing: $30 per user per month for the lowest licence type. Detailed pricing and volume discounts come from sales.⁴ The listing doesn’t say what the lowest licence type includes. A device company would need several modules, so we can’t turn this into an annual estimate for a 10-person team. Treat it as a floor, not a price.

Features

We found no public help center or release notes. The support page is a contact form.¹³ Module datasheets (mostly from 2023, some updated in 2026) describe the workflows step by step. Everything below comes from them, from product pages and from customer reviews.¹⁴

Document control and training

Documents go through initiation, collaboration and review, approval, and release on an effective date. Later they have scheduled periodic reviews, and old revisions are made obsolete and archived.¹⁵ Files can be managed through SharePoint and Google Drive integration.¹⁶ Two-way sync with them was announced for Service Pack 16.10.¹⁷ Training requirements are tied to roles, and exams are graded automatically. When an SOP changes, the system triggers retraining.¹⁸¹⁹

CAPA, nonconformance and change control

The CAPA datasheet documents initiation, investigation with risk assessment, action plans and an effectiveness review.²⁰ Nonconformances cover segregation of nonconforming material and disposition by a material review board.²¹ Change requests link to the document revisions they affect.²²

Complaints and vigilance reporting

This is the strongest area for device makers. Each region can have its own reportability decision tree, and reportable events get tasks with deadlines the system calculates. Pre-configured FDA MedWatch 3500 and EU MEDDEV 2.12-1 forms are included.²³ The adverse event module claims eMDR XML submissions with FDA acknowledgment tracking. An eMDR XML export was on the roadmap for Service Pack 16.10.²⁴¹⁷ A device customer reports setting up eMDR submission so it was ready at go-live.⁴ Field safety actions and recalls have their own workflow with health hazard assessment.²⁵

Supplier and audit management

Supplier qualification, supplier records, an approved supplier list and scorecards are documented. A supplier portal handles SCARs and audit responses.²⁶²⁷ Audits run from plan and schedule to checklists, findings and follow-up.²⁸

Design controls and risk

There’s no design control module yet. It’s part of Release 17.0 along with FMEA, PPAP and APQP.²⁹⁸ The current risk module is a general risk register with configurable evaluation criteria. It has no ISO 14971 hazard analysis or risk management file.³⁰ UDI, DHF/DMR and IEC 62304 support appear only as claims on the medical device page.⁹

What users say

• Capterra: 4.9/5 from 71 reviews, with 4.9/5 for ease of use and 5.0/5 for customer service (checked in a browser, 30 September 2026).¹⁰
• G2: 5.0/5 from 12 reviews, with 10/10 for both ease of use and support.³¹
• AppExchange: 5.0/5 from 63 reviews, every one of them 5 stars (context only; Capterra has more reviews).⁴

These scores are unusually high, so we read all 63 AppExchange reviews:⁴

• Year-end bursts: 23 were posted in three short windows in late December 2021, 2022 and 2023. No other month has more than three.
• Templated titles: many titles are variations of “Qualityze EQMS Implementation Experience”.
• Near-duplicates: one reviewer posted almost the same text for two employers.
• Cross-posting: at least 40 of the 71 Capterra reviews carry the same reviewer names and titles as AppExchange reviews, and Capterra shows the same late-December clusters. The two sites largely draw on the same people.¹⁰⁴
• Marketing reuse: the vendor reuses these reviews as testimonials and promotes its review-site badges in newsletters.¹³²

The reviews come from real customers, but many appear to come from organised drives soon after go-live. They say more about implementation than about daily use. Because three signs of an organised review drive are documented (bursts, templated text and cross-posting), our method caps the usability, support and sentiment scores at 8 instead of the 10 the raw ratings would give.

Common themes:

• Implementation and support get consistent praise from customers.⁴
• Ease of use is praised by several customers.⁴
• Learning curve and price. One AppExchange reviewer found learning the workflows hard at first.⁴ Capterra reviewers mention a steep learning curve, a high price and no self-serve trial.¹⁰

We found no independent discussion on Reddit or other forums.

Security, hosting and validation

Qualityze runs as a Salesforce managed package that passed Salesforce’s security review in October 2024 (version 16.8.0).⁴ Its security page describes SSO and multi-factor authentication through Salesforce, Salesforce Shield encryption and periodic third-party penetration tests. It names no certifications.¹¹ The company holds ISO 9001:2015 for its own quality system.³³

We found no hosting location, data processing agreement or subprocessor list. The privacy policy covers only the website and still refers to the EU-US Privacy Shield framework.¹² The validation package includes a validation plan, requirements, test scripts, a traceability matrix and a summary report.³⁴³⁵ The vendor says it comes with every update.¹

Buying and contract terms

• Trial: you book a 30-minute personalised demo.³⁶ The AppExchange listing offers no trial or test drive.⁴ In vendor case studies, buyers ran sandbox trials after their demos.⁷³⁷ Our trial score rests on those vendor case studies; Qualityze doesn’t advertise a trial on its website.
• Contract: Qualityze publishes no current subscription terms, so the minimum term is unknown. The only Qualityze terms we could read are a 2016 subscription agreement that its AppExchange listing showed in 2021. It renews subscriptions automatically unless either side gives 30 days’ notice, and you can’t reduce users during a term.³⁸
• Price increases: that agreement lets Qualityze raise prices at renewal with 30 days’ written notice, with no cap.³⁸ The AppExchange starting price of $30 per user per month hasn’t changed since at least January 2021.³⁹⁴ We found no user reports of renewal hikes.
• If Qualityze is sold or closes: the 2016 agreement says you own your data, but it doesn’t promise to return it at the end of the contract and has no escrow. Either party may transfer the contract in a merger or sale without consent, and Qualityze may end it if its own Salesforce agreement ends.³⁸
• Leaving: we found no documentation on exporting all records at the end of a contract. The vendor calls the platform “API-first”, but we found no public API documentation.⁵
• Go-live: this depends on how many modules you roll out. Reviewers report under a month for one to four modules and five months for ten modules at Highridge Medical.⁴ One vendor case study reports 11 modules and integrations in under six months.⁴⁰
• Migration: implementation includes migration templates. Case studies describe migrating 100,000 records and moving ZimVie off legacy quality and PLM systems.⁴¹³⁷⁶

Company and ownership

Qualityze Inc. is a Florida corporation (document number P15000008990), listed as active with its head office in Tampa.⁴² The company says it was founded in 2015.² It is privately held: the company describes itself as one of America’s “fastest growing private companies” on the 2024 Inc. 5000 list, with 198% three-year revenue growth.⁴³² Its Indian subsidiary, Qualityze Solutions Private Limited in Bangalore, is also registered as active.⁴⁴ Companies House lists no UK Qualityze company.⁴⁵ Its news releases from 2018 to 2026 announce no funding rounds, outside investors or acquisitions,⁴⁶ and it publishes no accounts.

Verdict

Qualityze scores 5.1. Device and combination-product manufacturers with several sites should shortlist it, especially if they run on Salesforce and need configurable complaint, eMDR, CAPA and supplier workflows. Don’t choose it for design controls or software development until Release 17.0 ships, and get pricing, contract terms, hosting location and a DPA in writing, because none of them are public.

Visit the Qualityze website (made by Qualityze Inc.)