Independent qualification of the software vendors and cloud/SaaS providers your GxP systems depend on — so you can leverage their evidence under CSA with confidence, not blind trust.
Scope
What we assess
CSA leans on vendor evidence — but only if the vendor is actually qualified. We make that determination defensible.
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Supplier audits
On-site or remote audits of software vendors against your GxP requirements.
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Cloud / SaaS qualification
IaaS, PaaS and SaaS providers assessed for GxP suitability.
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Quality system review
The vendor’s SDLC, testing and release controls.
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Security & data controls
Access, data segregation, backup and continuity.
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Evidence leverage map
What you can rely on vs. what you must test yourself.
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Ongoing oversight
Periodic re-qualification and supplier monitoring.
Deliverables
What you receive
- Vendor/cloud audit plan and checklist
- Audit report with risk-rated findings
- Evidence-leverage determination
- Gaps requiring your own controls or testing
- Supplier corrective-action follow-up
- Re-qualification schedule
- Alignment to CSA vendor-leverage principles
- Audit-ready documentation
Leverage with confidence. We tell you exactly what vendor evidence you can rely on and what you still need to control — the foundation of efficient CSA.
How it works
Qualified vendors, defensible leverage
STEP 01
Scope
Identify vendors and risk to your GxP use.
STEP 02
Audit
Assess the vendor’s quality and controls.
STEP 03
Determine
Map what evidence you can leverage.
STEP 04
Monitor
Re-qualify on a risk-based schedule.
Why SQA Solution
Why teams choose us
Enables efficient CSA
Vendor leverage is central to CSA; we make it defensible.
Independent & rigorous
An objective audit, not a rubber stamp.
Practical output
A clear leverage-vs-test determination you can act on.
Senior auditors
Experienced GxP auditors behind the findings.
Fixed-fee, transparent scope
A defined engagement with a defined price and timeline — no open-ended hourly billing. Scope scales to your systems and goals.
Get a scoped quoteQualify the vendors your validation depends on
Tell us which vendors or cloud providers are in scope. We’ll scope a fixed-fee audit.
Request a Quote
