ReviewsZenQMS

ZenQMS review

A configurable, validated eQMS for GxP life-science companies, priced without per-seat fees. It's built mainly for pharma, CROs and CDMOs, and its own comparison page calls device design-control support limited.

By · Updated

Price
on requestLast public prices $250–1,500 a month (2016–2018); implementation extra
Free trial
No free trialRecorded walk-through, live demo; sandbox for customers
EU hosting
US onlyAWS US; public DPA with SCCs; subprocessor list for customers only
Last checked
Oct 2026

What we like

  • No per-seat fees: each package includes a range of user licences, and all modules are included.
  • Validation plan, requirements traceability and IQ/OQ/PQ documents come with every release at no charge, plus UAT templates and a Part 11 / Annex 11 checklist.
  • A public help center with over 300 articles documents document control, training, change control, audits and supplier QSheets step by step.
  • Current ISO 27001:2022 certificate and a SOC 2 Type II report, a public DPA and a public REST API.
  • G2 reviewers repeatedly describe it as easy to use and praise the support team.

What to watch

  • ZenQMS's own comparison page calls its support for medical device design control limited; we found no risk-analysis, IEC 62304 or Jira and Git features.
  • No public prices, and until at least June 2026 every contract also carried an implementation fee priced per account.
  • Complaints, nonconformances and CAPA are configurable workflows without documented dedicated features, and SOP templates cost extra.
  • Data is hosted on AWS in the US only, and the subprocessor list is only available to customers.
  • Several G2 reviewers find the audits module clunky or dated compared with the rest of the system.

About the price: No public prices (Oct 2026); three packages (Calm, Clarity, Mastery) with a range of user licences instead of per-seat fees. Until at least June 2026 every contract also carried an implementation fee priced per account. Last published prices: $250–1,500 a month by item count (2016–2018).

What is ZenQMS?

ZenQMS is a cloud eQMS from ZenQMS LLC, a Pennsylvania company based in Ardmore. The company says it was founded in 2009 by two people from the contract manufacturing, contract research and clinical software world.12 It sells to GxP-regulated life-science companies:1

  • pharma and biotech
  • contract development, manufacturing and research organisations (CDMOs, CROs)
  • laboratories, packaging and logistics firms, and GxP software companies

Medical devices aren’t on that list. ZenQMS had a page for device companies until October 2025, but it has since been removed.3 Some customers do use it for ISO 13485 work, such as a buffer manufacturer, a life-science tools maker and a combination-product company.456

The product has modules for documents, training, issues, change control, audits, reporting and custom workflows. Every package includes all modules.7

Who ZenQMS is for

ZenQMS fits pharma, biotech, CRO and CDMO teams that want to configure their own workflows and need strong validation support. It also suits companies whose headcount grows quickly, since you don’t pay per seat.7

Look elsewhere if you:

  • Develop medical devices or software as a medical device. ZenQMS’s own comparison with Qualio says it has “limited support for medical device design control needs” and recommends Qualio for device companies that need extensive design control.8 We found no IEC 62304, risk-analysis or Jira and Git features.9
  • Need FDA MDR or EU vigilance reporting, UDI or post-market surveillance features. We found none.9
  • Need EU data hosting. ZenQMS hosts on AWS in the United States only.1011

ZenQMS pricing

ZenQMS doesn’t publish prices (checked 5 October 2026).7 The pricing page lists three packages:

  • Calm: for a first formal quality system or a move from paper.
  • Clarity: for replacing several disconnected systems, with more reporting.
  • Mastery: for multi-site and commercial-stage companies.

Each package includes “a range of user licenses”, so you can add users without paying for every seat. All modules are included, and Clarity and Mastery add advanced capabilities.7

From 2016 until at least June 2026, the pricing page said every contract had two items: implementation, and the application fee. Implementation was priced by the amount of data and the training needed.1213 The October 2026 page no longer mentions it, and doesn’t say the fee was dropped. Ask about it in your quote.

These cost extra:1415

  • QAtalyst SOP templates and pre-built workflows (one-time fee)
  • ZenSign external e-signatures
  • SCORM interactive training
  • the GxP training content library
  • Insights Pro reporting

The last published prices date from 2016–2018. They ranged from $250 to $1,500 a month, based on the number of documents, issues, CAPAs and audits in the account.12 We found no independent price data, so we can’t give an estimate.16 G2 reviewers often call ZenQMS affordable or good value, but give no figures.17

Features

We checked features against ZenQMS’s public help center (326 articles), its product pages and its case studies.9

Document control and training

Documents move from draft through review and approval to effective and retired. Signature steps can be added to a workflow as needed.1819 Files keep their native format. Teams can edit Word, Excel and PowerPoint files together through Microsoft for the Web inside ZenQMS.20 Controlled copies and exportable audit trails are documented.2122

Training is assigned by role, and a major document revision triggers retraining.23 Each person has a training dossier, and tests can require a pass score.2425

Issues, CAPA and change control

The Issues module is configurable. You build your own categories, stages, fields and signature points for deviations, CAPAs, complaints and investigations.26 The help center documents how to configure categories, not specific CAPA, complaint or nonconformance workflows. Ready-made workflows for these come with QAtalyst, which costs extra.14 A Salesforce integration can turn complaints logged in Salesforce into issues.27 Change control works the same way, with configurable stages and transitions.28

Audits and suppliers

The audits module covers planning, observations, report approval and sending reports to the auditee, plus recurring audits.29 Suppliers are kept in a vendor list with QSheets that hold site details and certificates.3031

Design controls and risk

ZenQMS has no dedicated design-control module. Its product pages say you can configure design control in the change-control module and import a traceability matrix.323 One customer, a combination-product company, runs its design history file and device master record as configured workflows.6 Risk assessments and FMEA appear only as example names for custom workflows.33 The vendor itself calls its device design-control support limited.8

What users say

  • Capterra: 4.5/5 from 20 reviews, with 4.5/5 for ease of use and 4.8/5 for customer service (checked in a browser, 5 October 2026).34
  • G2: we read 126 review texts through G2’s public feed. G2 blocks our browser, so its headline scores weren’t readable.17

G2 has far more reviews, but because we couldn’t read its ratings in a browser, we score on Capterra. We’ll check G2 again at the next review. The Capterra reviews are mostly old: 19 of the 20 date from 2015 to 2020, so they may not reflect the product you’d buy today.34 Thirteen of them arrived in two short bursts, in May and June 2015 and in August and September 2019. Capterra labels only one review as incentivized, and we found no other sign of an organised review drive, so we don’t cap these scores.

The G2 reviews (August 2021 to September 2026) are the only ones we could read as raw text.17 Recurring themes:

  • Easy to use. About half the reviewers praise ease of use or the interface.
  • Support. Most reviewers praise fast, helpful support. Three report problems, including one who found the help desk rude on a second request.
  • Audits module. Six reviewers describe it as unintuitive, clunky or dated compared with the rest of the system.35
  • Value. About ten reviewers call ZenQMS affordable or good value. None reports a price increase at renewal.

About a fifth of the reviews we found (26 of 126) were posted in one fortnight in September 2026, and earlier clusters fall in March 2022, November 2023 and August 2024.17 We couldn’t check G2’s labels for vendor-invited reviews. We found no first-hand posts outside the review sites.

Security, hosting and validation

ZenQMS holds an ISO 27001:2022 certificate valid until September 2027.36 It also has a SOC 2 Type II report, which it shares with customers.371 One FAQ answer still says ZenQMS isn’t certified by any certification body, which conflicts with the certificate.1

The application runs as a single multi-tenant instance on AWS in the United States.110 The data processing addendum is public and includes the EU standard contractual clauses. The subprocessor list is only available to customers.1138

Validation is a strength. Every release comes with a validation plan, requirements traceability and IQ/OQ/PQ documents. UAT templates and a Part 11 / Annex 11 checklist are provided at no charge.137 Single sign-on works with any SAML 2.0 provider, including Entra ID, Okta and OneLogin.39

Buying and contract terms

  • Trial: no free trial. The website offers a three-minute recorded walk-through and live group walk-throughs, and you can book a demo.4016 Customers get a sandbox.7
  • Contract: the customer agreement (updated 23 September 2026) isn’t public; you get it on request.41 ZenQMS describes an “annual fee” and says it doesn’t believe in long-term contracts.4232 Check the term and any price-increase clause in your order form.
  • Leaving: an account backup exports PDFs and CSV files for all core modules. Courses, training events and the users table are not included.43 The DPA says ZenQMS returns your data through its standard export at the end of the contract and then deletes it.11 We found no exit fee in public documents.
  • API: a public REST API with Swagger documentation.44
  • Go-live: the standard plan runs 30 to 90 days from kick-off, and an expedited plan aims for about 30 days. The FAQ gives an average of 90 days for documents and training.451 PharmaLex moved from MasterControl to ZenQMS in 100 days, according to a vendor case study.46
  • Price increases: with no public prices or customer agreement, there’s nothing to check. G2 reviewers report no renewal increases.17
  • If ZenQMS closes or is sold: the public documents say nothing specific about insolvency or a change of owner, beyond the end-of-contract export in the DPA.11

Company and ownership

  • Legal entity. ZenQMS LLC is an active Pennsylvania limited liability company (number 3935839), formerly named The Quality Advisory Board LLC.47
  • Related company. A ZenQMS Holdings LLC is registered in Delaware, with a branch in New Jersey. Its role isn’t stated in the sources we could read.48
  • Founded. 2009, according to the vendor.1
  • Ownership. Privately held. The co-founders lead it as CEO and CTO.2 We found no funding round, outside investor or acquisition on the vendor’s website or blog. As a private LLC, it files no public accounts.

Verdict

ZenQMS scores 5.9. It’s a validated, configurable eQMS for pharma, biotech, CRO and CDMO teams, with no seat fees and strong validation support. Medical device companies should hesitate. The vendor itself calls its design-control support limited, and there are no risk, IEC 62304 or device reporting features. Prices aren’t published, and hosting is US-only.

  1. ZenQMS: Frequently asked questions. Vendor website, checked 5 Oct 2026. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎ ↩︎

  2. ZenQMS: Our company. Vendor website, checked 5 Oct 2026. ↩︎ ↩︎

  3. ZenQMS for medical device companies, archived 13 Oct 2025. Vendor website via Wayback Machine (page now removed), checked 5 Oct 2026. ↩︎ ↩︎

  4. ZenQMS: Boston BioProducts customer story. Vendor case study, checked 5 Oct 2026. ↩︎

  5. ZenQMS: Molecular Loop customer story. Vendor case study, checked 5 Oct 2026. ↩︎

  6. ZenQMS: SQ Innovation customer story. Vendor case study, checked 5 Oct 2026. ↩︎ ↩︎

  7. ZenQMS: Pricing. Vendor website, checked 5 Oct 2026. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎

  8. ZenQMS vs. Qualio. Vendor comparison page (used only for statements about ZenQMS itself), checked 5 Oct 2026. ↩︎ ↩︎

  9. ZenQMS Support help center. Vendor documentation, 326 public articles read 5 Oct 2026. ↩︎ ↩︎ ↩︎

  10. ZenQMS: Privacy policy. Vendor legal page, last updated 28 Sep 2026, checked 5 Oct 2026. ↩︎ ↩︎

  11. ZenQMS: Data processing addendum, version 11.1. Vendor legal document, checked 5 Oct 2026. ↩︎ ↩︎ ↩︎ ↩︎

  12. ZenQMS pricing page, archived 27 May 2018. Vendor website via Wayback Machine, checked 5 Oct 2026. ↩︎ ↩︎

  13. ZenQMS pricing page, archived 10 Jun 2026. Vendor website via Wayback Machine, checked 5 Oct 2026. ↩︎

  14. ZenQMS: QAtalyst. Vendor website, checked 5 Oct 2026. ↩︎ ↩︎

  15. ZenQMS: Add-on features. Vendor website, checked 5 Oct 2026. ↩︎

  16. Capterra: ZenQMS pricing. Review site, read through a page summary 5 Oct 2026. ↩︎ ↩︎

  17. G2: ZenQMS reviews and its public review feed. Review site, 126 review texts read 5 Oct 2026. ↩︎ ↩︎ ↩︎ ↩︎ ↩︎

  18. ZenQMS help: Full document lifecycle overview. Vendor documentation, checked 5 Oct 2026. ↩︎

  19. ZenQMS help: Ad hoc signature steps for document workflows. Vendor documentation, checked 5 Oct 2026. ↩︎

  20. ZenQMS help: Microsoft for the Web, a collaborative document editing tool. Vendor documentation, checked 5 Oct 2026. ↩︎

  21. ZenQMS help: Issuing and destroying controlled copies. Vendor documentation, checked 5 Oct 2026. ↩︎

  22. ZenQMS help: Account audit trail overview. Vendor documentation, checked 5 Oct 2026. ↩︎

  23. ZenQMS: Training management software. Vendor website, checked 5 Oct 2026. ↩︎

  24. ZenQMS help: Training records (dossier). Vendor documentation, checked 5 Oct 2026. ↩︎

  25. ZenQMS help: Training tests. Vendor documentation, checked 5 Oct 2026. ↩︎

  26. ZenQMS: Issue management software. Vendor website, checked 5 Oct 2026. ↩︎

  27. ZenQMS help: Salesforce integration. Vendor documentation, checked 5 Oct 2026. ↩︎

  28. ZenQMS help: Stages and transitions for a change control category. Vendor documentation, checked 5 Oct 2026. ↩︎

  29. ZenQMS help: Audit lifecycle overview. Vendor documentation, checked 5 Oct 2026. ↩︎

  30. ZenQMS help: Site/vendor list overview. Vendor documentation, checked 5 Oct 2026. ↩︎

  31. ZenQMS help: QSheet overview. Vendor documentation, checked 5 Oct 2026. ↩︎

  32. ZenQMS for GxP software companies. Vendor website, checked 5 Oct 2026. ↩︎ ↩︎

  33. ZenQMS help: Organizing your quality processes with custom modules. Vendor documentation, checked 5 Oct 2026. ↩︎

  34. Capterra: ZenQMS reviews. Review site, ratings, review dates and review-source labels checked in a browser 5 Oct 2026. ↩︎ ↩︎

  35. G2 reviews by Samantha J. (Sep 2023), mark s. (Sep 2024) and Con B. (Sep 2026), among others. Review site, checked 5 Oct 2026. ↩︎

  36. ZenQMS ISO 27001:2022 certificate (TNV). Certificate issued 4 Aug 2026, checked 5 Oct 2026. ↩︎

  37. ZenQMS: Trust and compliance. Vendor website, checked 5 Oct 2026. ↩︎ ↩︎

  38. ZenQMS help: Getting a DPA and BAA in place with ZenQMS. Vendor documentation, checked 5 Oct 2026. ↩︎

  39. ZenQMS help: SSO compatibility. Vendor documentation, checked 5 Oct 2026. ↩︎

  40. ZenQMS: 3-minute walk-through. Vendor website, checked 5 Oct 2026. ↩︎

  41. ZenQMS: Acceptable use policy. Vendor legal page, last updated 28 Sep 2026, checked 5 Oct 2026. ↩︎

  42. ZenQMS: QMS software for life sciences. Vendor website, checked 5 Oct 2026. ↩︎

  43. ZenQMS help: Enabling an account backup. Vendor documentation, checked 5 Oct 2026. ↩︎

  44. ZenQMS help: API developer documentation and resources and the public API documentation. Vendor documentation, checked 5 Oct 2026. ↩︎

  45. ZenQMS help: Standard implementation process overview and expedited implementation process overview. Vendor documentation, checked 5 Oct 2026. ↩︎

  46. ZenQMS: How PharmaLex replaced MasterControl with ZenQMS in 100 days. Vendor case study, checked 5 Oct 2026. ↩︎

  47. OpenCorporates: ZenQMS LLC (Pennsylvania, 3935839). Mirror of the Pennsylvania company register, checked 5 Oct 2026. ↩︎

  48. OpenCorporates: ZenQMS Holdings LLC (Delaware, 6958024). Mirror of the Delaware company register, checked 5 Oct 2026. ↩︎

Visit the ZenQMS website (made by ZenQMS LLC)

Notable features

Built-in document editorNoFiles are uploaded in their native formats; no built-in editor
Edit in Word or Google DocsYesCollaborative editing in Word, Excel and PowerPoint through Microsoft for the Web inside ZenQMS
SOP templates includedNoSOP templates and pre-built workflows (QAtalyst) cost a one-time fee
Jira or Git integrationNot confirmed yetNo Jira or Git integration listed
IEC 62304 software featuresNot confirmed yetNo IEC 62304 features found
Validation package includedYesValidation plan, traceability and IQ/OQ/PQ with every release, at no charge
Public APIYesPublic REST API with Swagger documentation
Single sign-on (SSO)YesSAML 2.0, including Entra ID, Okta and OneLogin
Supplier portalNot confirmed yetNo supplier portal documented; external signatures through the paid ZenSign add-on
Training with quizzesYesTraining tests with pass scores; SCORM quizzes as an add-on
FDA MDR or EU vigilance reportingNot confirmed yetNo FDA MDR or EU vigilance reporting found
AI featuresYesNatural-language document search and AI-generated training questions
How we scored compliance coverage (17 ISO 13485, FDA and EU MDR requirements)
ClauseRequirementZenQMS
4.2.4Control of documents
4.2.5Control of records
6.2Training and competence
7.3Design and development
7.3.9Change control
7.4Supplier qualification and control
7.5Production records (DMR/DHR)
UDIUDI management (EU MDR, FDA)
8.2.2Complaint handling
8.2.3Regulatory reporting (FDA MDR, EU vigilance)
MDR 83Post-market surveillance
8.2.4Internal audit
8.3Nonconforming product
8.5.2Corrective action (CAPA)
ISO 14971Risk management file
IEC 62304Software lifecycle
Part 11Electronic signatures
Supported out of the boxPartial, or needs an add-onNot supportedNot confirmed yet

Frequently asked questions

How much does ZenQMS cost?
ZenQMS doesn’t publish prices (October 2026). It sells three packages, Calm, Clarity and Mastery, each with a range of user licences instead of per-seat fees. Until at least June 2026 its pricing page said every contract has two items: implementation and the application fee. The last published prices, from 2016–2018, were $250 to $1,500 a month depending on the number of documents and records.
Does ZenQMS have a free trial?
No. The website has a three-minute recorded walk-through and live group walk-throughs, and you can book a demo. Customers get a sandbox environment.
Where does ZenQMS host customer data?
On AWS in the United States. ZenQMS publishes a data processing addendum with EU standard contractual clauses, but we found no EU hosting option, and the subprocessor list is only available to customers.
Does ZenQMS support design controls and IEC 62304?
Only in a limited way. Design control is set up as a configured change-control workflow, and ZenQMS’s own comparison page says its support for medical device design control needs is limited. We found no IEC 62304, risk-analysis or Jira and Git features.
How long does it take to go live with ZenQMS?
ZenQMS’s standard implementation plan runs 30 to 90 days from kick-off, with an expedited plan of about 30 days. Its FAQ gives an average of 90 days for documents and training. SOP templates and pre-built workflows (QAtalyst) cost a one-time fee.
What are the alternatives to ZenQMS?
Compare ZenQMS side by side with any other system, or use our shortlist to rank all systems for your team size, product type and goal. Our ZenQMS pricing page compares its fees with other systems.

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