DRIVE · The CSV to CSA Operating Model

DRIVE: Documentation, Risk management, Implementation, Vendor assessment, Evidence management.

The CSA risk decision, in four steps

Inside DRIVE sits the decision that does the real work, applied at the function level rather than the system level.

Impact, implementation method, risk rating, right-sized testing, judged at the function level.

CSV and CSA, side by side

	Traditional CSV	CSA with DRIVE
Unit of risk	The whole system	The function or feature
Effort	Spread evenly, document-heavy	Concentrated where risk is
Testing	Scripted by default	Scripted, unscripted or vendor evidence, by risk
Supplier evidence	Re-created in-house	Assessed and leveraged
Engine	Templates and volume	Critical thinking, documented

What changes

Documentation falls by 25 to 50% on common system categories, effort concentrates where risk is, and the model extends cleanly to AI-enabled systems next. In a comparable multi-site programme, a Modular Qualification Architecture built on this thinking produced more than €10M in annual savings and cut equipment qualification cycle times by 45%.

Key takeaways

CSA is a return to validation's true intent, not a new methodology.
Risk is judged at the function level, not the system level.
Critical thinking, documented, is the engine. The matrix is just the scaffold.

See the CSV to CSA service → Take the CSA Maturity Index