Shift validation effort from paperwork to patient and product risk. We help pharma, biotech, medical device and CRO teams adopt the FDA’s Computer Software Assurance model — less documentation overhead, more meaningful assurance, fully inspection-ready.
The current guidance
CSA is now final FDA guidance — and we build to the current version
Computer Software Assurance is the FDA’s risk-based approach to validating software used in production and quality systems. It emphasizes critical thinking, unscripted and risk-based testing, and leveraging vendor evidence — replacing the document-heavy habits of traditional CSV.
Current as of 2026. The FDA finalized its CSA guidance, “Computer Software Assurance for Production and Quality System Software,” in September 2025, replacing the 2022 draft — and issued an updated final version on February 3, 2026, aligned to the new Quality Management System Regulation (QMSR), which took effect February 2, 2026. Our methodology reflects this current guidance, not the superseded draft.
The practical effect: you focus validation rigor where software failure could actually affect product quality or patient safety, and apply lighter, efficient assurance everywhere else — with defensible justification for both.
How CSA works
The principles we put into practice
◇
Risk-based thinking
Classify each system by intended use and process risk, then right-size assurance accordingly.
⚑
Unscripted & ad-hoc testing
Apply the testing approach that fits the risk — not exhaustive scripts for everything.
◎
Leverage vendor evidence
Use qualified supplier testing and evidence instead of re-testing what’s already proven.
▤
Lean documentation
Capture the evidence that demonstrates assurance — without binders no one reads.
◷
Continuous assurance
Maintain a documented state of control over the system’s life, not just at go-live.
§
Part 11 & data integrity
Electronic records, signatures and ALCOA++ integrity built into the assurance approach.
Our CSA services
How we help you adopt and run CSA
- CSA readiness and current-state assessment
- CSV → CSA transition program (operating model, SOPs, templates)
- Risk-based validation execution on your systems
- Vendor and cloud qualification to enable evidence leverage
- Part 11 and data-integrity assessment
- Periodic review and continuous assurance
- Team training and CSA enablement
- Audit-ready validation summary reports
Deliverable-level commitments. We provide defined, scoped deliverables and defensible, inspection-ready evidence. We don’t promise regulatory outcomes — we make your validation position as strong and current as it can be.
How it works
From traditional CSV to efficient, defensible CSA
STEP 01
Assess
Review current validation practice and CSA readiness.
STEP 02
Design
Define the risk-based operating model, SOPs and templates.
STEP 03
Execute
Apply CSA on your systems, leveraging vendor evidence.
STEP 04
Sustain
Continuous assurance and periodic review keep control.
Why SQA Solution
Be the current firm — with senior people behind it
Current with 2026 guidance
Aligned to the CSA final guidance (Feb 3, 2026, QMSR-aligned), GAMP 5 Second Edition and the EU Annex 11 draft — not the 2022 draft or last decade’s CSV playbook.
Risk-based, not paperwork-based
We put effort where real risk sits, giving you defensible assurance without wasted documentation.
Named senior consultants
Experienced validation practitioners who can defend the work to an inspector — not an anonymous capacity pool.
Life-sciences depth
15+ years validating regulated systems for pharma, biotech, device and CRO leaders, including Roche and Genentech.
Free self-check
How mature is your move to CSA?
A two-minute readiness check on Part 11 controls, data integrity and CSA maturity. Instant result, no sales call.
Adopt CSA the current, defensible way
Tell us where your validation program stands today. We’ll come back with a fixed-fee, scope-based path to risk-based assurance.
Request a Quote
