From Theory to Practice: How to Execute a CSA Validation in 4 Steps

Transitioning to Computer Software Assurance (CSA) can seem intimidating without a clear map. How do you decide what to test? How do you justify to an inspector that you didn't write a detailed protocol for everything? Here is an operational roadmap based on CSA best practices to transform your validation process.

Step 1: Identification of Intended Use and Risk Assessment

Everything starts with the Intended Use. What does the software do? Which processes does it support? Once the functions are mapped, apply the risk filter:

• High Risk (Critical): The feature has a direct impact on patient safety or product quality (e.g., dosage calculation, batch release).
• Non-High Risk (Low/Medium): The feature only impacts the business or has indirect impacts mitigated by other controls (e.g., training management, statistical reporting).

Step 2: Determine the Test Strategy (Scripted vs Unscripted)

This is the game-changer. Testing rigor must match the risk.

• For High Risk Functions: Use Scripted Testing. Here you need the classic step-by-step protocol with precise expected results and proof screenshots. You don't take risks on critical points.
• For Non-High Risk Functions: Use Unscripted Testing.
• Exploratory Testing: An expert user explores the system with a goal (charter) but without pre-set steps, looking for bugs and verifying usability.
• Ad-Hoc / Scenario Testing: Simulating a real workflow (e.g., "enter an order and close it") without writing down every single click.

Step 3: Execution and "Lean" Evidence Collection

Forget 500-page reports for a simple system. In unscripted tests, the evidence is a Test Log summarizing: "Who tested, what was tested, what was found." If everything works, a single line of confirmation is enough. If there is an error, the bug is documented in detail. Tip: Use digital tools or video recording for exploratory sessions, if the system allows, to have total traceability with zero paper.

Step 4: Supplier Management (SaaS and Cloud)

In the Cloud world, you cannot validate Amazon's or Google's infrastructure. CSA tells you to use Vendor Leveraging.

• Assess the supplier (Audit/ISO 27001 Certifications).
• Accept their baseline testing.
• Internally test only your configurations and critical processes. Do not duplicate work the vendor has already done!

⚠️ Watch Out For... The "No Document" Error

CSA does not mean "no documents." It means "documents that have value." Common Error: Doing exploratory testing without leaving a trace. Solution: Every exploratory session must have a "Charter" (objective) and a signed final Log. Without evidence, the test does not exist for the auditor.

Synthetic CSA Operational Checklist

• [ ] Approved Risk Assessment clearly distinguishing High vs Non-High risk.
• [ ] Test Plan including a mix of Scripted and Unscripted.
• [ ] Vendor Assessment for SaaS systems.
• [ ] Correctly completed Exploratory Test Logs.
• [ ] Discrepancy Log showing how issues were resolved.

Dive deeper with the complete guide on GuideGxP.com to download Risk Assessment and Test Log templates.