Computer Software Assurance (CSA) consulting
Still validating every system with exhaustive scripted testing? Risk-based software assurance built to the FDA's final CSA guidance. Spend validation effort where patient and product risk is highest.
The challenges this solves
Our validation is all paperwork
Teams spend more time writing scripted protocols than finding real defects.
We test everything the same way
Low-risk and high-risk functions get identical effort, so cycles stay long.
We pay twice for vendor testing
Qualified vendor evidence exists, but our process makes us repeat it.
What we deliver
- CSA readiness and current-state assessment
- CSV-to-CSA transition program: operating model, SOPs and templates
- Risk-based validation execution with unscripted and ad-hoc testing
- Vendor and cloud qualification so vendor evidence can be leveraged
- Part 11 and data integrity (ALCOA++) assessment
- Periodic review and continuous assurance
- Team training and CSA enablement
- Audit-ready validation summary reports
4 steps, clear deliverables
- 01
Assess
Review your current validation program and CSA readiness.
You receive: Current-state assessment
- 02
Design
Define a risk-based approach sized by intended use and process risk.
You receive: CSA operating model, SOPs and templates
- 03
Execute
Validate systems with risk-based, unscripted testing and leveraged vendor evidence.
You receive: Assurance evidence and summary report
- 04
Sustain
Keep assurance current through periodic review and continuous assurance.
You receive: Periodic review program
Want to know what this would take for your systems? Start with a short scoping call.
CSA transformation for a global pharmaceutical company
Validation cycle, down from 6–8 weeks
Less validation documentation
Exploratory, unscripted testing, up from 0% (previously 100% scripted)
Who we do this for
- Pharma & biopharma
- Biotech
- Medical devices
- CROs & clinical
Related services
Questions we hear most
What is Computer Software Assurance (CSA)?
CSA is the FDA's risk-based approach to assuring software used in production and quality systems. It focuses effort on critical thinking and risk, not documentation volume.
Which guidance do you build to?
We build to the FDA final guidance "Computer Software Assurance for Production and Quality System Software." It was finalized in September 2025 and updated February 3, 2026.
Does CSA replace Part 11 and data integrity requirements?
No. Part 11 and ALCOA++ data integrity still apply. CSA changes how much testing and documentation you need, not the controls themselves.
How is the work priced?
Fixed-fee engagements with a defined price, scope and timeline. No open-ended hourly billing.
Get a scoped CSA proposal
Tell us about your systems and we will send a fixed-fee proposal with a defined scope.