The FDA’s draft guidance on Computer Software Assurance (CSA) for manufacturing, operations, and quality system software places strong emphasis on the role of critical thinking during the implementation of automated systems. This marks a shift from traditional, documentation-heavy Computer System Validation (CSV) practices to a more streamlined, risk-based approach.
In the conventional CSV model, the process starts with extensive documentation, followed by testing, assurance considerations, and finally, critical thinking. CSA reverses this order, placing critical thinking at the forefront, followed by assurance planning, targeted testing, and only the necessary documentation.
Both the FDA and the industry are steering toward this new framework, aiming to improve efficiency without compromising quality or compliance.
Understanding the CSA Approach
The FDA’s CSA framework reorders how we think about validation with critical thinking at the core. Here’s how the model breaks down:
- Critical Thinking: Identify and define risks associated with each software feature based on how it impacts product quality or patient safety.
- Assurance: Verify that the functionality performs as intended in real-world use cases.
- Testing Activities: Choose appropriate testing methods, a mix of scripted and unscripted tests , based on the level of risk and complexity involved.
This guidance moves away from excessive documentation and instead emphasizes targeted testing, thoughtful analysis, and real-time assurance.
Let’s take a closer look at how scripted and unscripted testing fit into this approach.
Scripted vs. Unscripted Testing: LMS Example
In a Learning Management System (LMS), tasks like training need generation or session setup can be explored through unscripted testing, where testers freely interact with the system to spot issues or improvements.
Now consider a critical scenario: a production executive fails certification three times. The system should automatically restrict their access to production. This is high risk and requires scripted testing with defined steps and documented evidence.
Unscripted testing, especially when involving business users early, helps uncover missing features. Pairing this with low-code platforms allows rapid experimentation, applying critical thinking and improving assurance, well before formal validation begins.
AmpleLogic Implementation Model: Adoption of Practical, Evolving Technology
The FDA’s shift toward smarter, risk-based validation practices also opens the door for more efficient software delivery models. In line with this, research from Gartner anticipated that over 65% of application development would be driven by low-code platforms by 2025, a trend now actively changing regulated industries.
Low-Code Platforms:
Amplelogic’s Low-code is all about simplifying the mechanics of software development. By minimizing repetitive coding tasks, teams can work directly on the logic and workflows that matter, improving speed without losing control.
Instead of traditional back-and-forth development cycles, low-code enables a more hands-on model. A business user can outline a process, and the service provider can configure and demonstrate that workflow in real-time. This supports the Computer Software Assurance (CSA) model by allowing immediate feedback, iterative validation, and faster risk assessment.
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How Low Code Platform can help you achieve the CSA approach bypassing the Traditional Software service model?
The FDA’s CSA (Computer Software Assurance) model encourages smarter testing with less focus on documentation and more focus on system behavior, risk, and critical thinking. Low-code platforms fit well into this approach.
Drag and Drop visual Modelling:Â
Configuration and Experimentation Approach:
Instead of waiting for code to be written, users can explore system behavior right away by configuring features themselves. This encourages critical thinking and helps users figure out what the software really needs to do. It also helps add missing features early in the process.
This hands-on setup supports CSA’s goals by allowing faster changes and better understanding of the system.
User Requirements and Unscripted Testing
When users can see how the system works during development, they’re more likely to notice missing requirements or important use cases. This leads to more meaningful unscripted testing, where real scenarios can be tested without following a strict script.
By combining visual modeling and quick configuration, low-code platforms help reduce paperwork, shorten validation time, and follow a risk-based approach, just like CSA recommends.
Conclusion:
By combining critical thinking, assurance, and unscripted testing, low-code platforms enable smarter software validation through configuration and experimentation perfectly aligning with the FDA’s CSA approach.
CSA shifts the focus from heavy documentation to meaningful testing. When paired with low-code platforms, it allows users to visualize and validate software early in the requirements phase, saving both time and effort.
AmpleLogic has been at the forefront of GMP digitalization, offering solutions like:
- eQMS (Quality Management System)
- DMS (Document Management System)
- LMS (Learning Management System)
- QC Planning
- eLogs (Electronic Logbook System)
- Plus 20+ customized tools for Biopharma, Pharma, and Medical Device sectors
Book a free demo today to explore how our low-code platforms can streamline your compliance journey. Want to learn more? Visit our resources page for in-depth articles and insights.
