Cloud Assurance Certified
USDM’s Vendor Assurance Report gives quality teams leverageable evidence for supplier qualification and validation planning.
Make ZenQMS quality operations easier to validate, govern, and keep inspection-ready.
ZenQMS is a cloud eQMS built for quality teams that need document control, training, issues, CAPA, change control, audits, quality insights, and compliance status in one usable system. We help life sciences teams adopt ZenQMS with the GxP validation, vendor assurance, release assessment, and quality operating model needed to keep regulated workflows controlled.
Quality workflows
Documents, training, issues, CAPA, change control, audits, and insights stay connected in a configurable eQMS.
Validation without the drama
USDM helps qualify ZenQMS, assess releases, run regression testing, and maintain audit-ready evidence.
Partnership capabilities
Where we strengthen ZenQMS for regulated operations.
ZenQMS Qualification and Validation
Use USDM’s Cloud Assurance Certified audit, Vendor Assurance Report, validation strategy, requirements mapping, and CSA-aligned testing to qualify ZenQMS for intended GxP use.
Quality Process Design
Align documents, training, issues, CAPA, change control, audit management, roles, approvals, and quality records to the way your regulated teams actually work.
Continuous Cloud Compliance
Assess ZenQMS releases, maintain testing evidence, run regression testing of core requirements, and keep validated workflows ready for inspections instead of one-time go-live only.
Part 11, Annex 11, and Data Integrity
Strengthen electronic records, signatures, audit trails, access controls, training evidence, and data integrity expectations around ZenQMS-supported quality processes.
Cloud Assurance Certified
USDM certification and Vendor Assurance Report available for ZenQMS.
100,000+
Users cited on the legacy USDM ZenQMS partner page.
Core eQMS
Documents, training, issues, change control, audits, and quality insights.
Part 11 / Annex 11
ZenQMS public compliance positioning includes regulated electronic-record expectations.
Report
Request the USDM Vendor Assurance Report for ZenQMS
Get the Vendor Assurance Report for ZenQMS Cloud Assurance Certified assessment evidence, including supplier qualification and validation planning support.
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ZenQMS GxP operating model
Turn a usable eQMS into a defensible regulated quality system.
For life sciences quality teams, ease of use only matters if the system also remains qualified, controlled, and explainable under inspection. USDM adds that operating discipline around ZenQMS.
Supplier qualification
Leverage the Vendor Assurance Report instead of redoing vendor evidence.
The USDM audit package helps teams evaluate ZenQMS with stronger supplier evidence and less duplicated effort.
- Annual vendor audit evidence for ZenQMS supplier qualification.
- Vendor Assurance Report that supports validation planning and audit response.
- Assessment of compliance maturity, security, and data integrity controls.
- Clearer traceability from vendor controls to customer intended use.
Validated use
Validate the workflows that matter to your business.
ZenQMS can be configured to match quality processes; USDM helps keep those processes controlled.
- Requirements, risk assessment, and testing focused on intended GxP use.
- Document, training, issue, CAPA, change, and audit workflows aligned to SOPs.
- Part 11 / Annex 11 record, signature, audit trail, and access-control expectations.
- CSA-aligned testing that reduces low-value documentation while preserving evidence.
Sustainment
Keep ZenQMS inspection-ready as releases and processes change.
The real cost of a cloud eQMS often appears after go-live, when releases and process changes need controlled handling.
- Release impact assessment and regression testing for core requirements.
- Change-control support for configuration and process updates.
- Audit-ready evidence packages for inspections and supplier reviews.
- Ongoing advisory for quality process improvement and validation maintenance.
High-value ZenQMS motions
Where USDM makes ZenQMS easier to adopt and defend.
These ZenQMS operating needs are practical service paths for regulated teams.
Cloud Assurance
Use certified vendor evidence to reduce validation burden.
USDM Cloud Assurance gives teams leverageable vendor-audit evidence, accelerated initial validation support, and ongoing compliance maintenance for ZenQMS as the platform changes.
Quality process buildout
Design eQMS workflows around real quality operations.
We help map SOPs, roles, approvals, records, training assignments, CAPA, change control, and audit workflows into a practical ZenQMS operating model.
Inspection readiness
Make records easier to find, explain, and trust.
A controlled ZenQMS implementation gives quality teams a clearer source of truth for records, training status, audit evidence, and compliance posture.
FAQ
ZenQMS questions for regulated life sciences teams.
What does Cloud Assurance Certified mean for ZenQMS?
It means USDM has performed a structured vendor assessment and publishes a Vendor Assurance Report that regulated customers can leverage for supplier qualification, validation planning, and audit-ready evidence.
Does USDM validate ZenQMS for my company?
USDM helps define intended use, risk, requirements, testing strategy, configuration controls, and evidence for your ZenQMS implementation. The vendor report is leverageable evidence, but each company still validates its own intended use.
Which quality processes can ZenQMS support?
ZenQMS publicly positions modules for training, document management, issues, change control, audits, quality insights, data security, and compliance. USDM helps align those modules to GxP workflows, SOPs, and inspection expectations.
How does Cloud Assurance help after ZenQMS goes live?
Cloud Assurance supports release impact assessment, regression testing, change-control evidence, and ongoing compliance maintenance so the validated state does not drift as ZenQMS and your quality processes evolve.
Resources
Related ZenQMS Resources
ZenQMS and USDM resources for eQMS selection, GxP qualification, Cloud Assurance certification, validation, Part 11 / Annex 11 controls, and quality operations.
Report
USDM Vendor Assurance Report for ZenQMS
Request the USDM Vendor Assurance Report for ZenQMS Cloud Assurance Certified assessment evidence.
Datasheet
Open the Cloud Assurance Datasheet
USDM datasheet for Cloud Assurance, validation support, release assessment, and continuous compliance.
Webinar
Simplify GxP Quality Assurance
On-demand webinar with ZenQMS and USDM on selecting, qualifying, and validating cloud-based eQMS systems for GxP.
Demo
Watch the ZenQMS demo
Short ZenQMS product demo for teams evaluating eQMS usability, configuration, and quality workflows.
Press Release
ZenQMS partners with USDM Life Sciences
USDM announcement describing the ZenQMS and USDM Cloud Assurance Certified partnership.
Compliance
USDM Cloud Assurance
USDM’s continuous compliance model for validated cloud platforms and GxP applications.
Blog
USDM’s Guide to 21 CFR Part 11 Compliance
USDM guidance on electronic records, electronic signatures, audit trails, and compliance expectations.
Framework
Computer Software Assurance
Risk-based software assurance practices for regulated systems and quality processes.
Official
ZenQMS eQMS Platform
Official ZenQMS overview for electronic quality management.
Official
ZenQMS Training Module
Official ZenQMS training management module page.
Official
ZenQMS Document Module
Official ZenQMS document management module page.
Official
ZenQMS Change Control Module
Official ZenQMS change-control management module page.
Official
ZenQMS Issues Module
Official ZenQMS issues, CAPA, and change-control module page.
Official
ZenQMS Audits Module
Official ZenQMS audit management module page.
Official
ZenQMS Trust and Compliance
Official ZenQMS page for data security and compliance posture.
Customer perspective
What ZenQMS customers are saying.
Quality, manufacturing, and biopharma teams point to ZenQMS usability, configuration flexibility, and practical support as reasons the platform works for their operations.
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“ZenQMS’ user-friendliness and the ability to customize around our processes are what I responded to when doing my research. So when I saw the price, I thought it was quite reasonable and almost too good to be true. I’m getting so much more than I thought I would with ZenQMS.”
Technology partnerships
Want to learn more about our technology partnerships or become an official partner?
Talk with USDM about partner programs, regulated technology adoption, and ways we can help life sciences teams get more value from platforms like ZenQMS.