Top Computer Software Assurance (CSA) Insights for Regulated Life Sciences
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.
Quick Summary
- CSA shifts effort from documentation to critical thinking — instead of spending 80% of your time documenting and 20% testing, CSA flips it so 80% goes to critical thinking and risk-based testing and 20% to documentation.
- The FDA's Center for Devices and Radiological Health (CDRH) draft guidance for CSA applies to manufacturing, operations, and quality system software.
- This page collects USDM eBooks, white papers, webinars, blogs, and a case study to help you understand and adopt CSA within your existing CSV and QA SOPs.
Considering CSA? Here's What You Need to Know
The purpose of adopting the CSA methodology is to reset expectations in the life sciences industry and to use technology to drive information analytics. Instead of spending 80% of your time documenting and only 20% of your time testing, the CSA methodology flips it so that 80% of your time is spent on critical thinking and applying the right level of testing to higher-risk activities, while only 20% of your time is spent documenting. Download the eBook to learn more.
New to the framework? Start with our overview of Computer Software Assurance (CSA) and how it relates to the broader practice of 21 CFR Part 11 compliance before you map your own risk-based approach.
Adapting Computer System Validation to Accommodate Evolving FDA Guidance
There is a lot of discussion in the life sciences industry about the U.S. Food and Drug Administration (FDA) changing focus from compliance to quality and encouraging the use of automation and new technologies to enable more effective testing and less time spent on documentation. Slated for December 2021, the FDA's Center for Devices and Radiological Health (CDRH) plans to release new draft guidance for CSA that applies to manufacturing, operations, and quality system software.
CSA reframes validation around critical thinking and risk — the right level of testing on the activities that matter most, with documentation that proves it rather than burying it.
Get Your Company Ready for CSA
In our webinar, Update from the FDA on CSV Changes, half of our attendees indicated that it was difficult or very difficult to get their company to adopt the CSA approach. If your company falls into that category and you want to know how to identify the intended use of a software application, determine your risk-based approach, leverage existing activities for each function, and identify the required records, download this checklist to help you prepare your company to adopt the CSA methodology.
How to Approach a CSA Assessment
- Identify the intended use of each software application within your process.
- Determine a risk-based approach by classifying functions as low, medium, or high risk.
- Leverage existing activities for each function instead of recreating effort.
- Identify the required records that serve as objective evidence of assurance.
This same risk lens carries into data integrity work and ongoing validation lifecycle management for your regulated systems.
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.
FAQ: Computer Software Assurance (CSA) for Life Sciences
What is the difference between CSV and CSA?
Computer System Validation (CSV) has historically been documentation-heavy, with roughly 80% of effort spent on documentation and 20% on testing. Computer Software Assurance (CSA) flips that ratio so most of the effort goes to critical thinking and risk-based testing, with documentation serving as objective evidence rather than the goal itself.
Who does the FDA's CSA guidance apply to?
The FDA's Center for Devices and Radiological Health (CDRH) draft guidance for CSA applies to manufacturing, operations, and quality system software, with proposed changes focused on medical device companies and their supporting systems.
How do I determine the right level of testing under CSA?
Start by identifying the intended use of each software application, then classify functions by risk (low, medium, or high). Higher-risk functions warrant more rigorous testing, while lower-risk functions can leverage existing activities and lighter records.
How does CSA relate to 21 CFR Part 11 and data integrity?
CSA is a risk-based assurance methodology that supports — but does not replace — your obligations under 21 CFR Part 11 and your broader data integrity controls. Applying CSA thinking helps you focus assurance effort where electronic records and signatures carry the most risk.
How can USDM help my company adopt CSA?
USDM helps regulated companies adopt Computer Software Assurance principles within their existing CSV and QA SOPs, including identifying intended use, defining a risk-based approach, leveraging existing activities, and establishing the required records. Contact us to discuss your CSA roadmap.
Ready to Modernize Your Validation Approach?
Whether you are evaluating CSA for the first time or scaling it across your quality systems, USDM can help you build a defensible, risk-based program. Contact our team to get started, or explore ongoing validation lifecycle management for regulated life sciences teams.