Move your validation program from document-heavy CSV to the FDA’s risk-based Computer Software Assurance model — less paperwork, more assurance where it matters, fully defensible.
Scope
What the transition delivers
A structured shift in how your organization validates — methodology, templates, SOPs and team capability.
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CSA operating model
A risk-based validation model tailored to your systems and risk appetite.
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Updated SOPs & templates
Validation procedures and lean deliverables aligned to CSA.
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Critical-thinking framework
Right-sizing assurance by intended use and risk, not by habit.
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Unscripted & risk-based testing
Adopting the testing approaches CSA encourages.
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Vendor-leverage model
Using qualified vendor evidence to avoid redundant work.
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Team enablement
Training so your team sustains CSA after we’re done.
Deliverables
What you receive
- CSA readiness and current-state assessment
- Target CSA operating model
- Updated SOPs and lean templates
- Risk-based testing framework
- Vendor-evidence leverage approach
- Pilot on a representative system
- Team training and enablement
- Transition roadmap with milestones
Current and defensible. Aligned to the FDA CSA final guidance finalized Sept 2025 and updated Feb 3, 2026 (QMSR-aligned) — the operating model regulators now expect.
How it works
From CSV habit to CSA capability
STEP 01
Assess
Current-state and CSA-readiness review.
STEP 02
Design
Target operating model, SOPs, templates.
STEP 03
Pilot
Prove it on a representative system.
STEP 04
Enable
Train the team and roll out.
Why SQA Solution
Why teams choose us
Current, not 2022
Built on the Feb 2026 CSA final guidance, QMSR-aligned.
Less paperwork, more assurance
Effort flows to real risk, not binder volume.
Sustainable
We leave your team able to run CSA, not dependent on us.
Senior practitioners
Led by consultants who’ve made the shift before.
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 quoteModernize your validation program
Tell us where your validation stands today. We’ll scope a fixed-fee transition program.
Request a Quote
