eQMS validation
Implementing or upgrading an eQMS? Validate your electronic quality management system as configured for your processes. We work to Part 11, Annex 11 and CSA expectations.
The challenges this solves
Every upgrade means re-validation
Vendor releases arrive on a schedule, and our testing cannot keep pace.
We re-test what the vendor already tested
Our process ignores qualified vendor evidence.
Our configuration is what really matters
Workflows for CAPA, deviations and change control need focused testing.
What we deliver
- Document and change control workflows
- CAPA and deviation workflows
- Training records
- Part 11 controls: audit-trail and e-signature verification
- Integrations with other quality and business systems
- Release and upgrade change control
- Periodic review
Systems and tools
- Veeva Vault QMS
- Veeva Vault QualityDocs
- MasterControl
- TrackWise Digital
4 steps, clear deliverables
- 01
Scope
Map configuration, workflows and integrations.
You receive: Configuration-specific validation plan
- 02
Assess
Leverage vendor evidence under CSA and target the gaps.
You receive: User requirements and configuration specs
- 03
Validate
Run risk-based testing of critical workflows.
You receive: Test protocols, traceability matrix and summary report
- 04
Sustain
Run periodic review and upgrade change control.
You receive: Release and upgrade change-control process
Want to know what this would take for your systems? Start with a short scoping call.
Who we do this for
- Pharma & biopharma
- Biotech
- Medical devices
- Cell & gene therapy
Related services
Questions we hear most
Which eQMS platforms do you validate?
Veeva Vault QMS, MasterControl and others. Our validated systems list also includes TrackWise Digital and Veeva Vault QualityDocs.
How does CSA change eQMS validation?
We rely on qualified vendor evidence and focus testing on your configuration and high-risk workflows.
How is the work priced?
Fixed-fee engagements with a defined price, scope and timeline. No open-ended hourly billing. Scope scales to your systems and goals.
Validate your eQMS the efficient, defensible way
Get a scoped, fixed-fee quote for your platform and configuration.