What is critical thinking?

 

Data Integrity App

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.

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?

 

Critical Thinking

As the manufacturer—the company and people producing the product—you know the business and you know the processes. You’ve got the best insight into how risk is introduced, where it matters, and what’s going on from a process standpoint.

Critical thinking is considering where the system could introduce a risk versus what is a product or process risk. This helps you tell your story, whether it is to the FDA or an arbitrary regulator and auditor.

Demonstrate that you can tell that story, that you’ve got the element of understanding and control about your product and your processes. There is no one-size-fits-all for any company or system.

The FDA wants to know that you really understand your processes and systems and that you are in control. Ensure that you can tell the FDA you know where the risk is being introduced, how you will mitigate the risk, and whether the controls you put in place are working.

 

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.

 

 

 “Trust but Verify “ Ronald Reagan

 

Across the internet, there are millions of resources are available which provide information about Everything.

 

If you found all content under one roof then it will save your time, effort & you will more concentrated on your important activity.

Data Integrity App


 

Our Data integrity app will helpful for understanding what Data integrity & CSV really means & How 21 CFR Part 11, EU Annex 11 & other regulatory guidelines affects in pharmaceutical Industry.

 

Data Integrity App Include 

- Basic Data Integrity Concepts

- ERES & Its Requirement

- CSV & Its best practices 

- Mock Inspection and General Q&A

- Checklist for inspection

- Inspection Readiness

- Useful SOP’s

- Stay Regulatory Compliant.

 

“Stay One Step Ahead in Pharma IT Compliance” 


Data Integrity App Link:


https://play.google.com/store/apps/details?id=com.innovativeapps.dataintegrity

 

Try our "Data Integrity" app which helps you to better understand current regulatory agencies thinking on Data Integrity & CSV.


 

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