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Checklist: Transitioning from CSV to CSA

29If 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 assurancepatient and product safety, and data integrity.

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