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:
Know your suppliers (perform supplier audits)
Know the intended use of your computer system(s)
Know high-risk features, operations, and functions
Know the existing gaps in your current validations
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.
People - Performance against objectives/goals, skill levels, capabilities of team.
Process - Quantify and analyze the quality of performance, progress, process, or activities. Focus on what is working well.
Product - Define criteria that will help research, manufacturing, and marketing evaluate the success of your product and product characteristics
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.
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.
Perform CSV Assessment - Customize your CSV assessment against the FDA’s future CSA guidance and define what you can change.
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.