Gap assessment during the FDA’s CSA transition

The FDA’s shift from Computerized System Validation (CSV) to Computer Software Assurance (CSA) represents a paradigm change in compliance strategy. Life Sciences must move from exhaustive documentation toward a risk-based, critical-thinking approach. Gap Assessments provide a structured pathway to identify compliance gaps, prioritize remediation, and enable a smooth transition without compromising regulatory integrity. 

Why Gap Assessment matters 

The Gap Assessment is the foundation for CSA adoption. It ensures: 

• Compliance Alignment: Evaluates current validation practices against CSA guidelines such as exhaustive documentation and testing for low-risk systems by adopting streamlined, risk-based documentation and unscripted testing. 
• Risk-Based Focus: Identifies high-risk systems, functionalities and processes for prioritized remediation. Thus, instead of validating every requirement equally, focus on functions impacting product quality or patient safety. 
• Efficiency Gains: Highlights opportunities to reduce redundant documentation and testing such as adopting automated testing tools to replace manual scripts for non-critical functions; hence, shortening validation cycles, reduced cost and faster time-to-market.
• Audit Readiness: Prepares organizations for FDA inspections under CSA guideline demonstrates proactive compliance and reduce audits findings.

Gap Assessment methodology 

A best practice approach combines regulatory expertise with practical implementation strategies: 

1. Current State Analysis 
   • Review SOPs, validation deliverables, and testing protocols. 
   • Benchmark against CSA guidance and GAMP 5 principles. 
   • Establish a compliance baseline and highlight inefficiencies. 

2. Gap Identification 
   • Map discrepancies between CSV and CSA requirements. 
   • Assess risk categorization and assurance activities. 
   • Provide clarity on what needs to change for CSA alignment. 

3. Risk Prioritization 
   • Rank systems and processes based on compliance impact. 
   • Focus on critical features affecting product quality and patient safety. 
   • Optimizes resource allocation to reduce unnecessary effort. 

4. Actionable Roadmap 
   • Develop a phased remediation plan and ensure smooth transition and audit readiness. 
   • Provide updated templates, risk-based testing strategies, and training modules. 
   • Introduce automated testing tools for non-critical functions to accelerate validation. 
   • Establish CSA-based periodic reviews to maintain compliance by moving beyond traditional checklist audits and adopt a risk-based, critical-thinking approach. 

Benefits of partnering with Gap Assessment experts 

• Regulatory Expertise: Deep knowledge of FDA guidance and CSA principles. 
• Scalable Solutions: Compliance as a Service (CaaS) and Validation as a Service (VaaS) options. 
• Efficiency & Quality: Streamlined validation processes without sacrificing compliance. 
• Audit Support: Assistance during FDA inspections and readiness reviews. 

Next steps 

Sikich can help you modernize your validation framework and achieve CSA compliance efficiently. Contact us today to schedule your Gap Assessment and start building a risk-based validation strategy that meets FDA expectations.