Explore our top insights on Computer System Validation (CSV) guidance and learn what the risk-based approach of Computer Software Assurance (CSA) means to the regulated life sciences industry. These resources are filled with practical advice from the U.S. Food and Drug Administration (FDA) and USDM subject matter experts.

Computer Software Assurance: What You Need to Know About the FDA's Upcoming Guidance

The FDA is expected to release a new guidance document, Computer Software Assurance for Manufacturing, Operations and Quality System Software, in 2021. These proposed changes are focused on medical device companies and their supporting systems. After reading this white paper, Computer Software Assurance: What You Need to Know About the FDA’s Upcoming Guidance, you will know how to identify the intended use of the software application, determine a risk-based approach, leverage existing activities for each function, and identify the required records.


Update from the FDA on CSV Changes

In this on-demand webinar, learn from the FDA’s Francisco Vicenty and USDM’s Sandy Hedberg about what the upcoming Computer System Validation guidance is and get clarity on what the Computer Software Assurance approach means for regulated life sciences companies. You’ll see examples of risk evaluation and acceptable records for the new focus.


Q&A with the FDA on CSV Changes

In our webinar Update from the FDA on CSV Changes, we received more questions than we could answer in the allotted time. In this exclusive on-demand webinar, you’ll hear the FDA’s Francisco Vicenty and USDM’s Sandy Hedberg, Diane Gleinser, and John Petrakis answer questions in five categories – general CSA questions, testing and documentation, software and systems, vendors and suppliers, and FDA/auditors/other agencies. For example:

  • How is this different from GAMP/GAMP5?
  • How do you define low, medium, and high risk?
  • What serves as objective evidence as required by FDA in CSA?
  • What are the CSA implications in the Agile software development process?
  • What are examples of direct and indirect systems?
  • How does CSA relate to our third-party software?
  • What is the FDA’s plan to train auditors and the industry on what documentation is expected?


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. The industry and the FDA are working together to optimize the process through which systems and technologies are validated. Learn how USDM can help you adopt Computer Software Assurance principles within your existing CSV and QA SOPs.


Q&A: CSV, CSA, and Why the Paradigm Shift

This blog post answers some common questions about Computer Software Assurance and what it means for regulated life sciences companies. The FDA’s Francisco Vicenty, Case for Quality Program Manager, addresses topics like the difference between CSV and CSA, who the CSA framework is for, and how to handle audit trails.


Case Study: CSA Approach Significantly Improves Platform Efficiencies

Learn how USDM deployed Computer Software Assurance methodologies to drive meaningful efficiencies for a large biotech customer. USDM’s solution provided a 50% decrease in validation cost and time, and significantly reduced testing overhead.

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