Editor's note: This is the second post in a series of five covering CSA. You can find them all here.
The FDA released General Principles of Software Validation on January 11, 2002—nearly two decades ago. Considering how much technology has advanced, it's hard to believe we rely on guidance written almost 20 years ago to validate our software systems. The FDA agrees, which is why the Agency is introducing computer software assurance (CSA), a new approach to traditional computer software validation (CSV), to bridge the gap between technology and guidance.
The most significant difference between the two methods is that CSV focuses on documentation, i.e., a "test everything" approach, while CSA encourages us to use critical thinking to test more effectively. In this post, we’ll examine the importance of critical thinking and its application to CSA.
What is critical thinking?
Critical thinking is a complex subject that’s difficult to define. Generally speaking, it is the rational, skeptical and unbiased analysis of factual evidence. The ability to reason is a critical thinking skill. Reasoning occurs when we use our knowledge of one thing, process or statement to determine if another thing, process or statement is true.
Logic is another key element of critical thinking. People often confuse reason with logic, but they’re not the same. Reason is subject to personal opinion or bias; logic is strictly fact-based. Logic states if A=B and B=C, then A=C. It doesn’t matter how you feel about A, B or C; it’s a fact. We call this factual statement a premise. Premises help us draw conclusions.
Logical thinking is about connecting one thing with another. Critical thinking is about making sure those connections are valid and not influenced by assumptions or bias. You must become a logical thinker before you can become a critical thinker. But how?
The four steps of logical thinking
Step 1: Ask the right questions—To become a logical thinker, you must ask many questions. What is the premise? Is the premise a fact or value (i.e., what I think it should be based on my belief system)? Am I missing a premise or piece of vital information? You cannot draw a conclusion without a premise.
Step 2: Organize the data—Once you know the premise, you organize the data by making connections. Organizing the data entails breaking up the information, diagraming it, laying out the premise, and then figuring out how to illustrate it.
Step 3: Evaluate the data—Next, you must evaluate the data to determine if the information is valid. You cannot draw a conclusion until you distinguish between truth and validity. Tread carefully—do not allow belief bias to interfere with your ability to come to a logical conclusion.
Step 4: Draw your conclusion—Only infer what the data implies, do not add or subtract from it. Check to ensure your inferences are consistent. Identify any underlying assumptions you may have.
Are critical thinkers born or made?
Critical thinkers are not born. We can all learn these skills and reap the benefits. Critical thinking helps you become a more persuasive communicator, a more effective problem solver and increases your emotional intelligence. Here’s how you can hone your critical thinking skills:
Practice active listening
Be curious and ask clarifying questions
See the big picture
Be objective (it’s the antidote for bias!)
Use your emotions carefully (don’t let them cloud your judgment)
Be self-aware (analyze your assumptions and biases)
How does critical thinking apply to CSA?
Now that we know what critical thinking is and why it’s important, let’s examine how it applies to CSA and validation in general.
When we perform validation, we must comply with regulatory requirements, our company’s quality system and standard operating procedures (SOPs). Critical thinking ensures that we effectively analyze the situation and validate high-priority items to the highest degree of rigor and lower priority items to the appropriate level.
Note: This blog post summarizes the second episode of a five-part podcast series devoted to CSA. In my next post/episode, I’ll focus on assurance needs and what you need to address in this validation phase.
Press the play button to listen to the full podcast of episode two.
Steve Thompson has worked in Life Sciences for over two decades in both Information Technology and Quality Assurance roles. He’s a certified systems auditor and has audited hundreds of companies globally. A published author, a frequent speaker at industry conferences, on the Board as a Director for PRCSQA, Editorial Advisory Board for ISPE, and Elite Faculty member for KENX, and Adjunct Lecturer, Temple University, School of Pharmacy, RA/QA Graduate Program. He was honored with an APEX 2020 award of excellence for a peer-reviewed article he co-authored for Pharmaceutical Engineering on Blockchain. Currently, as Director Industry Solutions at ValGenesis, Steve helps Life Science organizations realize the potential benefits of advanced technologies, along with inherent risks.