Learn what the FDA’s Computer Software Assurance (CSA) approach means for regulated life sciences companies
Feedback from our Forward-Thinking GxP Compliance & Process Optimization event in January indicated that many in the industry wanted to learn the fundamentals of CSA. Sandy Hedberg fulfills that request in this on-demand webinar.
USDM has been applying a CSA methodology with our clients for more than a year. In this session, we explain the intentions and principles behind the guidance and why this simplified, risk-based approach to Computer System Validation (CSV) can be applied to IT systems today.
What you’ll learn
- Why the FDA is shifting its language and emphasis from “validation” to “assurance.”
- What Computer Software Assurance means in practical terms for regulated life sciences companies.
- How a risk-based CSA approach differs from traditional CSV.
- How a simplified, risk-based method can be applied to your IT systems today.
- What real transitions to CSA look like, drawn from USDM client case studies.
Who should watch
This webinar is geared toward life sciences professionals new to the industry and pre-commercial companies selecting their IT systems. If you want the foundational counterpart first, watch An Introduction to Computer System Validation.
What this CSA discussion covers
- Why the FDA is moving from “validation” to “assurance”
- What CSA means to regulated life sciences companies
- What is different from the traditional CSV
- Case studies from companies that have transitioned to CSA
USDM’s point of view: CSA is not a loophole to do less — it is a smarter way to focus effort where it actually reduces risk. By emphasizing critical thinking and risk-based testing over exhaustive documentation, teams move faster without sacrificing data integrity or audit readiness. USDM has been applying this methodology with clients for over a year, and pairing it with 21 CFR Part 11 discipline is how regulated companies turn compliance from a bottleneck into a competitive advantage.
Presenter
Sandy Hedberg, Director, Quality and Regulatory Affairs, USDM Life Sciences
Sandy has more than 30 years of experience in Quality and Regulatory Affairs in the medical device, pharmaceutical, and biologics industries. She has assisted companies with responses to consent decrees and audit findings to the FDA. She is well versed in risk analysis, creating quality procedures, computer system validation, auditing, and authoring regulatory submissions.
FAQ: Computer Software Assurance (CSA)
What is Computer Software Assurance (CSA)?
CSA is a simplified, risk-based approach to Computer System Validation (CSV). It reflects the FDA’s shift in emphasis from “validation” to “assurance,” concentrating effort on the testing and evidence that genuinely reduce patient and product risk. You can learn more on our Computer Software Assurance page.
How is CSA different from traditional CSV?
Traditional CSV often leads teams to produce extensive documentation regardless of risk. CSA applies a risk-based lens so that the depth of testing and documentation is proportional to how critical a system or function is. The webinar walks through what specifically changes versus the traditional CSV approach.
Can CSA be applied to my IT systems today?
Yes. USDM has been applying a CSA methodology with clients for more than a year, and the session explains how the intentions and principles behind the guidance can be put to work on IT systems now — not at some future date.
Should I watch this before or after the CSV webinar?
If you are new to the industry or selecting IT systems at a pre-commercial company, start with An Introduction to Computer System Validation for the foundations, then watch this CSA session to see how the risk-based approach builds on them.
How does CSA relate to broader compliance and security obligations?
CSA addresses how you validate and assure software, but regulated systems also carry data integrity, electronic records, and security responsibilities. A complete program connects CSA with 21 CFR Part 11 compliance and a sound approach to life sciences cybersecurity so that assurance, records, and security reinforce one another.
Keep validated systems continuously compliant
Adopting CSA is the start; keeping validated cloud systems compliant through every vendor update is the ongoing work. USDM’s Cloud Assurance subscription offloads validation and cloud release management so your team stays audit-ready over time.
Additional Resources
- Video with Cisco Vicenty of the FDA: FDA Perspectives on Cloud Technologies
- White Paper: Considering CSA? Here’s what you need to know
- Case Study: Pharmaceutical Company Transitions to CSA Model with USDM Expertise
Watch the on-demand webinar. Register to stream An Introduction to Computer Software Assurance with Sandy Hedberg, then contact USDM to talk through applying a risk-based CSA approach to your specific GxP systems.