ZenQMS
zenqms.com
What it is
ZenQMS is a cloud electronic quality management system for GxP-regulated life sciences organizations. It brings document control, training, CAPAs, deviations, complaints, change controls, audits, supplier management, electronic signatures, risk management and quality reporting into one service. The browser-based application requires no local installation, while Android and iOS access are listed. ZenQMS says its platform is validated for GxP under 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 electronic records and signatures comply with 21 CFR Part 11. Integrations include Okta, Entra ID, Active Directory and Salesforce. A documented API provides read access to several quality records, and a visual builder creates two-way connections without developers. Human support covers setup through go-live; Documents and Training typically go live in an average of 90 days. Pricing is on request.
Spec sheet
- Product
- ZenQMS is a cloud-based electronic quality management system for GxP-regulated life sciences organizations.Read 11 Oct 2026 · zenqms.com
- API
- ZenQMS provides a documented public API with read access to documents, training records, CAPAs, issues, and change requests.Read 11 Oct 2026 · zenqms.com
- 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.Read 11 Oct 2026 · zenqms.com
- 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.Read 11 Oct 2026 · zenqms.com
- Support
- ZenQMS describes ongoing human support as included and says its support team helps with setup, configuration, training, and go-live.Read 11 Oct 2026 · zenqms.com
- Founded
- 2009Read 28 Sep 2026 · zenqms.com
- Browser access
- ZenQMS is accessed through a browser and does not require local software installation; the FAQ also refers to mobile applications.Read 11 Oct 2026 · zenqms.com
- Company history
- ZenQMS says it was founded in 2009 by two industry leaders with experience in the CMO/CRO or clinical IVRS fields.Read 11 Oct 2026 · zenqms.com
- Hosting
- ZenQMS says its application and database servers are hosted by Amazon Web Services.Read 11 Oct 2026 · zenqms.com
- Implementation
- ZenQMS says organizations typically go live with Documents and Training in an average of 90 days.Read 11 Oct 2026 · zenqms.com
- No-code integration builder
- ZenQMS offers a visual integration designer for building two-way data connections without developers.Read 11 Oct 2026 · zenqms.com
- 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.Read 11 Oct 2026 · zenqms.com
- Quality processes
- The platform supports document control, training, CAPAs, deviations, complaints, change controls, audits, supplier management, e-signatures, risk management, and quality reporting.Read 11 Oct 2026 · zenqms.com
- 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.Read 11 Oct 2026 · zenqms.com
Plans and prices
Calm Priced on request Core package for controlled, compliant processes · Includes all ZenQMS modules · Headcount buffer allows adding users without per-seat charges Read 11 Oct 2026 · zenqms.com
Clarity Priced on request For connecting separate quality systems and improving visibility, reporting, and process consistency · Includes all ZenQMS modules · Advanced capabilities Read 11 Oct 2026 · zenqms.com
Mastery Priced on request For commercial-stage, multi-site or global organizations with complex quality and regulatory environments · Includes all ZenQMS modules · Advanced capabilities Read 11 Oct 2026 · zenqms.com
Strong points and limits
Strong points
- Covers documents, training, audits and corrective actions
- Browser access without local installation
- Validated for GxP with release documentation
- Public API and no-code integration designer
- Human support through go-live
Limits
- Paid service with pricing on request
- Slack and LIMS or ERP connections coming soon
- Typical Documents and Training go-live averages 90 days
Who it suits
It suits GxP-regulated life sciences organizations managing controlled documents, training, audits, corrective actions and related quality processes. Teams needing browser access, compliance records and integrations can assess its listed capabilities.
Verdict
ZenQMS combines a broad set of regulated quality processes in a cloud service with browser, mobile and API access. Its validation, compliance listings and implementation support are central considerations for prospective buyers.
Where Specifiction places it
- Quality Management Software#29 of 376.8