Checklist: Transitioning from CSV to CSA

If you are starting your preparation, aim to be proactive and develop a strategy on how to transition your current CSV framework to a CSA and focus on quality assurance, patient and product safety, and data integrity.

Per system, start to inventory and understand all of the following:

  1. Know your suppliers (perform supplier audits)

  2. Know the intended use of your computer system(s)

  3. Know high-risk features, operations, and functions

  4. Know the existing gaps in your current validations

  5. Define a plan to close the gaps

Understand your current business and processes, resources, gaps, and improvement points and start setting up metrics for successful implementation.

  1. People - Performance against objectives/goals, skill levels, capabilities of team.

  2. Process - Quantify and analyze the quality of performance, progress, process, or activities. Focus on what is working well.

  3. Product - Define criteria that will help research, manufacturing, and marketing evaluate the success of your product and product characteristics

  4. Project - Measure key performance indicators (KPIs) related to project management and project control.

After identifying gaps and opportunities, you are positioned to develop a transition plan to CSA.

  1. Develop a Transition Plan - Create, document, and execute your road map that specifies roles, responsibilities, deliverables, and measured outcomes. Metrics, data collection, and risks should be established and addressed in this plan.

  2. Perform CSV Assessment - Customize your CSV assessment against the FDA’s future CSA guidance and define what you can change.

  3. Develop and Train on CSA - Lift your team’s understanding of the importance CSV, CSA, and the implication.

Revise Change Management Business Processes - Review streamline critical business processes and focus on: quality assurance, patient and product safety, and data integrity.


In need of expertise in preparing your transition? One of pi life sciences' consultants is glad to help.