How to Align your CSV Program with the FDA’s CSA Approach

The life sciences industry’s quest for improved patient safety and product quality is heavily dependent on the use of technology throughout its business processes. These technologies include on-premise, cloud, enterprise, manufacturing, laboratory, instruments, and equipment.

To support this quest, the industry and the U.S. Food and Drug Administration (FDA) are working together to optimize the process through which these systems and technologies are validated. This initiative, led by the FDA, is called Computer Software Assurance (CSA). CSA is the FDA’s endorsement of and “how to improve” the risk-based approach to validation.

CSA is a process to optimize validation, not a replacement of validation. CSA concepts are acceptable under current regulations. The FDA is actively encouraging the approach and has confirmed that inspectors are being aligned with CSA. Guidance on CSA is on the FDA’s A list and planned for release in December 2021.

The Center for Devices and Radiological Health (CDRH) is working in cooperation with the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) on CSA, making the guidance applicable to the life sciences industry.

As the FDA moves forward, USDM fully understands, accepts, and respects that computer systems must be validated for each company and the users’ intended use. Additionally, these systems can only be validated by the company under their respective policies and procedures.

USDM offers a framework on how a life sciences company can begin to understand and adopt some of the CSA principles now and do so within their company’s existing Computer System Validation (CSV) and QA Standard Operating Procedures (SOPs). USDM’s CSA framework offers flexible, adaptable points of entry that fit your unique need – a virtual workshop, training, a validation process assessment, support to pilot a CSA project, or revision to your validation methodology, and SOPs to adopt the CSA principals. The steps you take will get you closer to realizing the many benefits of CSA processes and procedures.

USDM has been supporting life sciences organizations to validate their IT systems through the continually evolving approach to validation. Further, USDM is on the leading edge of best practices in validation for advanced technologies (i.e., relational technologies, shared services, advanced analytics and AI/ML tools, IoT, and SaaS systems.). USDM is working closely with the FDA to ensure our support to life sciences companies is current and aligned with recommended practices.

Please contact us if you would like to discuss your unique approach to CSA today.

CSA Program Deliverables

• CSA training and education
• Preliminary feedback and recommendations on your CSA plan and roadmap
• Summary report detailing recommendations and next steps
• CSA roadmap
• CSA Assurance Plan
• Complete validation sets for on-premise and cloud applications

Why Partner with USDM

• 20+ years of life sciences domain expertise
• Thousands of GxP projects delivered globally
• Bridge the gap between Quality and IT
• Flexible delivery models to meet your need
• Reduced risk with qualified SMEs and best-in-class project management
• Efficient onboarding and knowledge transfer built on virtual playbook best practices

Learn how USDM deployed CSA methodologies to drive meaningful efficiencies for a large biotech customer in this case study.

Additional CSA References

• Blog: Top CSA Insights
• Webinar: Update from the FDA on CSV Changes
• White Paper: CSA: What You Need to Know About the FDA’s Upcoming Guidance
• White Paper: Regulatory Risk Reduction in the Cloud: Why Cloud Systems Are Safer Than On-Premise Systems
• Blog: Lessons from USDM’s Cloud Assurance Automated Testing Tool for Box GxP

About the Author

Jim Macdonell is the Vice President of Medical Device Solutions at USDM Life Sciences. Jim is responsible for driving solutions for our medical device customers and staying at the forefront of regulatory and technology challenges facing the medical device industry. Jim is a seasoned consulting leader with more than 25 years of experience defining client strategies and building and managing implementation teams.