Validation for electronic quality management systems — Veeva Vault QMS, MasterControl and others — configured to your processes and validated to Part 11, Annex 11 and CSA expectations.
What we validate
Your eQMS is where quality lives — we validate the configuration, workflows and integrations that run it.
Document & change control
Controlled documents, change control and revision workflows validated end to end.
CAPA & deviations
The investigation and corrective-action workflows inspectors scrutinize.
Training records
Validated training-record management tied to controlled documents.
Part 11 controls
E-signatures, audit trails and access controls verified.
Integrations
Validated data flows to and from connected systems.
Periodic review
Keeping the validated state in control through upgrades and releases.
What you receive
- Configuration-specific validation plan
- User requirements & configuration specs
- Risk-based test protocols
- Audit-trail and e-signature verification
- Vendor evidence leveraged under CSA
- Traceability matrix
- Release and upgrade change control
- Audit-ready validation summary report
Risk-based, vendor-leveraged. Under CSA we lean on qualified vendor evidence and focus testing on your configuration and high-risk workflows — faster, and defensible.
A validated eQMS that stays validated
Scope
Map configuration, workflows and integrations.
Assess
Leverage vendor evidence; target the gaps.
Validate
Risk-based testing of critical workflows.
Sustain
Periodic review and upgrade change control.
Why teams choose us
Platform-aware
We know how Veeva and MasterControl actually behave — not a generic checklist.
CSA-efficient
Vendor-leveraged assurance that avoids redundant testing.
Current with 2026 guidance
Part 11, Annex 11 draft and FDA CSA final guidance.
Senior practitioners
Defensible work from named consultants.
A defined engagement with a defined price and timeline — no open-ended hourly billing. Scope scales to your systems and goals.
Get a scoped quoteValidate your eQMS the efficient, defensible way
Tell us your platform and configuration. We’ll scope a fixed-fee validation.
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