CSV to CSA transition program
Ready to move from CSV to CSA, but not sure where to start? Move your validation program from document-heavy CSV to the FDA's risk-based CSA model. Less paperwork, and more assurance where risk is highest.
The challenges this solves
Our SOPs still assume CSV
Procedures and templates force scripted testing and full documentation for every system.
We do not know how to start
The guidance is final, but we lack a model, a pilot and a rollout plan.
We cannot depend on consultants forever
We need our own team to run CSA after the transition ends.
What we deliver
- CSA operating model tailored to your systems and risk appetite
- Updated SOPs and lean templates
- Critical-thinking framework that sizes assurance by intended use and risk
- Unscripted and risk-based testing approaches
- Vendor-leverage model that uses qualified vendor evidence to avoid duplicate work
- Pilot on a representative system
- Team training so you can sustain CSA on your own
- Transition roadmap with milestones
4 steps, clear deliverables
- 01
Assess
Review your current state and CSA readiness.
You receive: CSA readiness and current-state assessment
- 02
Design
Define the target operating model, SOPs and templates.
You receive: Target CSA operating model, SOPs and templates
- 03
Pilot
Prove the model on a representative system.
You receive: Pilot results and risk-based testing framework
- 04
Enable
Train your team and roll the model out.
You receive: Training and transition roadmap with milestones
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 changes when we move from CSV to CSA?
Assurance is sized by intended use and risk. High-risk functions get rigorous testing. Lower-risk functions use unscripted testing and lighter records.
Do we need to revalidate existing systems?
Not as part of the transition. The new model applies going forward, starting with a pilot on one representative system.
Will our team be able to run CSA without you?
Yes, that is the goal. The program ends with training and enablement so your team can sustain CSA independently.
How is the program priced?
Fixed-fee engagements with a defined price, scope and timeline. No open-ended hourly billing.
Plan your move to CSA
Get a fixed-fee proposal with a defined scope, timeline and pilot system.