Qualio vs Veeva Vault QMS: price, contract and features compared

Both serve companies that make medical devices, drugs or both, but at different sizes. Qualio is a cloud eQMS for life sciences companies, known for being easy to learn, with design controls and Jira links in its standard plans.¹² Veeva Systems sells its quality products as separate applications on its Vault platform, with strong complaint, CAPA and supplier workflows and a public help center.³⁴

Who each is built for

Qualio fits a device company of roughly 10 to 50 people that wants a system non-quality staff will adopt and prefers a guided rollout, with an eight-week onboarding programme and a dedicated onboarding manager.⁵ Deviations, OOS and pharmacovigilance sit in the same platform as its device design controls, so it also suits combined device-and-drug companies.⁶

Veeva Vault QMS fits large and multi-site companies, especially those that make both devices and drugs. Cardinal Health, with about 46,500 employees, uses it across its pharmaceutical and medical device businesses.⁷ It shares a platform with Veeva’s regulatory and clinical products.³ Veeva’s own product for small device companies is QuickVault, a separate application we haven’t reviewed.⁸

Price and contract terms

Neither publishes prices. Qualio’s pricing page lists Foundation, Growth and Scale plans without amounts, and every plan carries an implementation fee that isn’t published.¹ Archived copies show annual plans from $12,000 in August 2020 and $14,000 in January 2021.⁹¹⁰ We estimate $12,000 to $30,000 a year for a 10-person team, plus the implementation fee.¹¹

For Veeva, Vendr’s underlying data shows a fixed “Quality Base” subscription of about $24,200 to $24,600, plus per-unit prices for QMS, QualityDocs and Training. If those are yearly per-user prices, 10 users would cost roughly $54,000 to $56,000 a year before implementation. That is one source, from buyers with far more than 10 users, so we show Veeva’s price as on request.¹² Implementation is sold as professional services.¹³

Qualio’s terms leave the term to each order form, and its pricing page describes an annual subscription. Fees are non-cancellable, you can’t reduce seats during a term, and Qualio can set a new fee for each renewal after notice, with no cap. If it does, you can terminate with 30 days’ notice before your term ends.¹⁴¹ Veeva’s customer terms aren’t public. Its annual report says subscriptions are “typically for a term of one year”, and that some contracts rise at renewal by the lower of 4% or US inflation, without saying whether quality contracts do.¹³

On exit, Qualio gives you up to 30 days after termination to retrieve your data, with documented exports of documents, training, events, suppliers and the audit trail in PDF, Word, XLSX and CSV. Its REST API is on the Growth plan.^14151617 Veeva customers can export records, audit history and document metadata to CSV, and documents with their renditions, using built-in tools, and there’s a public API.¹⁸¹⁹²⁰

Design controls and risk

Qualio has the stronger design side. Both standard plans include design controls with up to three requirement levels and verification and validation test cases, a design change review generates trace matrices, and risk management is built on ISO 14971.¹²¹²² Jira is included; GitHub, GitLab and Azure DevOps need the Integration Hub add-on. We found no IEC 62304 features such as software safety classes or SOUP lists.¹²¹

Veeva’s QualityDocs stores design history files as documents. Requirements with automated trace matrices are on the Veeva PLM page, a separate product we could only check against marketing copy.³²³ Veeva QMS supports risk matrices with ISO 14971-style probabilities, risk registers and process FMEA, with no design risk file linked to requirements and tests.²⁴ We found no IEC 62304 features and no Jira or Git integration.

Complaints, CAPA and post-market

Veeva has the stronger post-market side. Complaints, CAPA, audits and suppliers are delivered processes, a complaint intake step triages reports, and QMS manages field corrective actions under 21 CFR 806 and EU PSURs.^4252627 FDA eMDR and EU MIR files come from Product Surveillance, an add-on that Veeva lists as “Early”, with 1 to 10 customers.²⁸²⁹ UDI submissions are in Veeva RIM, another product.³⁰

Qualio runs CAPAs, nonconformances and complaints in a configurable Events module. Its help center documents the CAPA workflow, including reopening a CAPA when its effectiveness check fails, but complaints appear only as an example template.³¹³² We found no FDA MDR or EU vigilance reporting and no UDI management.³³ Neither vendor documents a disposition step for nonconforming product.¹¹³⁴

Documents and training

Qualio has an in-app editor with co-editing, and Word editing through OneDrive.³⁵³⁶ Several reviewers report that its editor handles formatting worse than Word and that search is clunky.³⁷ Trainees must pass multiple-choice assessments with 100% before signing off.³⁸

Veeva’s QualityDocs keeps documents as files with document change control, Read & Understood workflows and periodic reviews, and several people can co-edit in Word, Excel and PowerPoint through Microsoft 365.³⁹⁴⁰ Its Training product assigns training by role and can include quizzes.⁴¹

Hosting, security and validation

Qualio’s public subprocessor list names one web-application host, AWS in Dublin, and its DPA is public and uses standard contractual clauses.⁴²⁴³ Veeva hosts on AWS, with Vault servers in the US, Japan and Germany, and publishes its subprocessor list. It doesn’t say how a customer’s location is chosen, and its DPA is offered only on request.⁴⁴⁴⁵⁴⁶

Qualio lists ISO/IEC 27001 among its certifications, and we found no mention of SOC 2.⁴³¹⁵ Veeva is audited every year against ISO 27001 and publishes a SOC 2 Type II report.⁴⁷ Qualio follows FDA’s Computer Software Assurance approach, with a validation pack that includes a Part 11 assessment; it doesn’t say whether the pack costs extra.⁴⁸⁴⁹ Veeva performs and documents IQ and OQ for each general release and publishes a validation package.⁵⁰

What users say

Qualio has 781 reviews on G2, averaging 4.4/5, with 9.0/10 for ease of use (663 ratings) and 9.1/10 for quality of support (561 ratings), as of September 2026.² Veeva has two small G2 listings: 4.1/5 from 10 reviews for QMS and 4.5/5 from 14 for QualityDocs, with no sub-scores (checked October 2026).⁵¹⁵² Most reviews on both vendors’ listings are labelled as invited or incentivized, so our usability, support and sentiment scores are capped at 8.²⁵¹

Go-live and trial

Qualio says most customers are live in 30 to 60 days. Its team migrates and formats your existing Word documents, and SOP templates cost extra.¹⁵ Veeva publishes no implementation time, recommends a Veeva team or partner for data migration, and ships configured workflows rather than procedures.⁵³⁴

Neither offers a free trial. Qualio has an interactive product tour and a demo, with a sandbox only for customers in implementation.⁵⁴⁵⁵ Veeva has recorded demos on its website, live demos go through sales, and sandboxes are for customers.⁵⁶⁵⁷

Choose Qualio if…

• you’re a team of roughly 10 to 50 people and want a system your whole company will use;
• you want design controls, ISO 14971 risk and Jira links in the QMS;
• you want EU hosting with a public DPA and a guided rollout in weeks.

Choose Veeva Vault QMS if…

• you’re a large or multi-site company, or make both devices and drugs at scale;
• complaints, field corrective actions, EU PSURs and eMDR matter more to you than design controls;
• you already use Veeva for regulatory or clinical work.