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ZenQMS

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What ZenQMS is

ZenQMS is a cloud-based electronic quality management system for GxP-regulated life sciences organizations. Its modules cover document control, training, CAPAs, deviations, complaints, change controls, audits, supplier management, e-signatures, risk management, and quality reporting. Teams access it in a browser without installing local software; the FAQ also refers to mobile apps. ZenQMS says its validation follows GAMP 5 Category 4 and FDA system validation guidance, with documentation for each release. It lists ISO 9001:2015, ISO 27001:2022, SOC 2 Type II, and USDM Cloud Assurance, and says its electronic records and signatures comply with 21 CFR Part 11. Pre-built integrations include Okta, Entra ID, Active Directory, and Salesforce. A documented public API offers read access to selected records, and a visual designer supports two-way data connections without developers. Human support for setup, configuration, training, and go-live is described as included. ZenQMS says Documents and Training typically go live in an average of 90 days. Founded in 2009, it is paid, with pricing on request.

Who it suits

It suits GxP-regulated life sciences organizations that need to manage quality processes in one system. Its Calm plan is described for controlled, compliant processes, while Mastery and Clarity address more complex or connected quality environments.

What it does well

Covers documents, training, audits, CAPAs, and other quality processes.
Browser access requires no local software installation.
Public API provides read access to selected records.
Human support is included, according to ZenQMS.

What to know first

Pricing is available on request, not listed.
Slack and LIMS or ERP connections are marked coming soon.

Limits

Pricing is available on request. Slack and LIMS or ERP connections are marked coming soon.

Plans

Plan	Billed and limits	Price
Calm	Core package for controlled, compliant processes · Includes all ZenQMS modules · Headcount buffer allows adding users without per-seat charges	On request
Mastery	For commercial-stage, multi-site or global organizations with complex quality and regulatory environments · Includes all ZenQMS modules · Advanced capabilities	On request
Clarity	For connecting separate quality systems and improving visibility, reporting, and process consistency · Includes all ZenQMS modules · Advanced capabilities	On request

As zenqms.com lists them, read 11 Oct 2026. The maker's own page has the final word.

Getting started

Visit https://www.zenqms.com/ and access the platform through a browser.
Request pricing for the paid service.
Choose a plan: Calm, Mastery or Clarity, based on the plan description that fits your organization.
Work with the support team on setup, configuration, training and go-live.

Verdict

ZenQMS brings a broad set of regulated quality processes into a cloud system, with listed validation, compliance credentials, and integration options. Organizations should request pricing and check whether its current integrations and implementation timeline fit their needs.

Questions

How much does ZenQMS cost?

ZenQMS is paid, and pricing is available on request.

What plans are available?

Calm, Mastery and Clarity are listed. All include ZenQMS modules, with distinct descriptions for controlled processes, complex commercial or global organizations, and connecting separate quality systems.

Can users access ZenQMS on mobile?

ZenQMS is accessed through a browser without local software installation, and its FAQ also refers to mobile applications. Android and iOS are listed platforms.

Which integrations are available?

Pre-built integrations include Okta, Entra ID, Active Directory and Salesforce. Slack and LIMS or ERP connections are marked coming soon.

Does ZenQMS provide an API?

Yes. Its documented public API offers read access to documents, training records, CAPAs, issues and change requests.

Who makes ZenQMS, and when was it founded?

ZenQMS says it was founded in 2009 by two industry leaders with experience in CMO/CRO or clinical IVRS fields.

Facts from ZenQMS's own pages

API: ZenQMS provides a documented public API with read access to documents, training records, CAPAs, issues, and change requests. · zenqms.com, 11 Oct 2026
Browser access: ZenQMS is accessed through a browser and does not require local software installation; the FAQ also refers to mobile applications. · zenqms.com, 11 Oct 2026
Company history: ZenQMS says it was founded in 2009 by two industry leaders with experience in the CMO/CRO or clinical IVRS fields. · zenqms.com, 11 Oct 2026
Compliance: ZenQMS lists ISO 9001:2015, ISO 27001:2022, SOC 2 Type II, and USDM Cloud Assurance, and says its electronic signatures and records comply with 21 CFR Part 11. · zenqms.com, 11 Oct 2026
Founded: 2009 · zenqms.com, 28 Sept 2026
Hosting: ZenQMS says its application and database servers are hosted by Amazon Web Services. · zenqms.com, 11 Oct 2026
Implementation: ZenQMS says organizations typically go live with Documents and Training in an average of 90 days. · zenqms.com, 11 Oct 2026
Integrations: Pre-built integrations include Okta, Entra ID, Active Directory, and Salesforce; Slack and LIMS or ERP connections are marked coming soon on the integrations page. · zenqms.com, 11 Oct 2026
No-code integration builder: ZenQMS offers a visual integration designer for building two-way data connections without developers. · zenqms.com, 11 Oct 2026
Pricing model: Pricing depends on the package and organization size; ZenQMS says packages include a range of user licenses rather than charging for each individual seat. · zenqms.com, 11 Oct 2026
Product: ZenQMS is a cloud-based electronic quality management system for GxP-regulated life sciences organizations. · zenqms.com, 11 Oct 2026
Quality processes: The platform supports document control, training, CAPAs, deviations, complaints, change controls, audits, supplier management, e-signatures, risk management, and quality reporting. · zenqms.com, 11 Oct 2026
Support: ZenQMS describes ongoing human support as included and says its support team helps with setup, configuration, training, and go-live. · zenqms.com, 11 Oct 2026
Validation: ZenQMS says its platform is validated for GxP according to GAMP 5 Category 4 guidance and FDA system validation guidance, with validation documentation for each release. · zenqms.com, 11 Oct 2026

Where ZenQMS stands on Freedom251

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