What is Critical Thinking?
Critical thinking is a method of objectively analyzing the data on any problem, subject or content in order to form a judgement. It is an intellectually disciplined process of evaluating information generated from observations, structured around universal intellectual values such as precision, clarity, reasoning, consistence and relevance. This type of thinking can include scientific, mathematical, historical methods amongst others.
A critical thinker should be objective, analytical, a problem solver and respect facts. “Unless we develop these skills, our ability to see is limited by our biases, assumptions, history, culture, emotions, and many other factors.” Monica Cahilly, President, Green Mountain Quality Assurance LLC, 2016
Critical Thinking Flowchart
Flowchart summarised from the Foundation for Critical Thinking
How does Critical Thinking apply to Data Integrity?
“The application of critical thinking skills is important to not only identify gaps in data governance, but to also challenge the effectiveness of the procedural and systematic controls in place.” The European Medicines Agency Questions and Answers on Data Integrity August 2016
Many organisations use critical thinking training programs including the CIA, NATO and the WHO. Investigators at the FDA Basic Drug School are taught critical thinking because it allows them to see risks more quickly. They understand that critical thinking is an essential tool to garner accurate results.
Applying Critical Thinking in the following ways can benefit your Organisation
- Critical thinking is essential to Data Integrity as it relates to the methods and processes carried out before, during and with the maintenance of tasks. This includes the quality of design, risk assessment and risk management, product life cycle and data life cycle. “Have all possibilities and complexities been embraced and what could go wrong” are some of the questions that must be asked.
- Statistical analyses are used to identify data trends across a range of different data sets and for this information to be correctly utilised, critical thinking must be applied to the results using objectivity, logic and reason. Biases and blind spots must be acknowledged, factored and countered in the analysis.
- Analysis of missing data, inconsistent data and/or deviations can be indicative of data integrity problems and by applying critical thinking, through objective investigation, root causes can be established, corrective actions taken, and preventative procedures put in place
These are the standards set by The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH, E6 R2) and those which Dataworks’ staff and management follow daily in order that our clients receive impeccable data governance, solutions and complete Data Integrity. It is critical to our way of thinking.
If you are utilizing automation and software systems to achieve compliance and help drive Operational Excellence, then complying with Data Integrity regulations is critical.
Our validation team have strong technical skills and experience which gives them a much deeper understanding of the Data Integrity regulations and the impact they have on your governance and development and validation life cycles. They have been trained and mentored to ensure that Critical Thinking is a core skill they apply when completing Data Integrity audits, gap analysis and validation remediations.
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