6 Steps to Critical Thinking & Risk-Based Tools

The incorporation of critical thinking and risk-based computerized tools has become crucial for maintaining validation and regulatory compliance in FDA-regulated industries.

To address this challenge, this article will discuss six steps that contribute to these two elements that can help you ensure regulatory compliance. 

One of the key aspects of achieving regulatory compliance in FDA regulated industries is to have a thorough understanding of the applicable regulations and guidelines. 

Critical thinking plays a vital role in this process, as it enables professionals to analyze and interpret these complex regulations. Thus, ensuring that the organization’s operations align with the required standards.  Using critical thinking to maintain validation and regulatory compliance in FDA regulated industries is crucial to ensure that products and processes meet the required standards and are safe for public use.

Critical Thinking

By engaging in critical thinking, professionals can identify potential gaps or areas of non-compliance and take proactive measures to address them.

Here are some steps to apply critical thinking in this context:

• Understand the Regulations: Familiarize yourself and your team with the relevant FDA regulations that apply to your industry. This includes FDA guidelines, Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and any other specific regulations that pertain to your product or process.
• Analyze the Requirements: Carefully analyze the regulatory requirements to identify the key criteria and standards that must be met. This may involve reviewing documentation, guidance documents, and any recent updates or changes to the regulations.
• Identify Potential Gaps: Use critical thinking to identify any gaps in your current validation processes, procedures, or documentation that may not comply with the regulations. Assess the potential risks associated with these gaps.
• Develop Risk Management Strategies: Based on the identified gaps, develop risk management strategies to mitigate potential issues. Prioritize actions based on the severity of the risks and allocate resources accordingly.
• Conduct Thorough Validations: Ensure that all required validations are conducted thoroughly and accurately. Critical thinking is essential when designing validation protocols, executing tests, and interpreting results.
• Document Everything: Maintain detailed and organized documentation throughout the validation process. Critical thinking can help you ensure that all relevant information is recorded, and any discrepancies or deviations are properly addressed and documented.

For a complete list of Critical Thinking and Risk-based steps, click bit.ly/3OBxXVM 

In summary, using critical thinking in FDA regulated industries involves understanding the regulations, identifying potential gaps, conducting thorough validations, maintaining meticulous documentation, and fostering a culture of compliance and continuous improvement.

Risk Based Tools

An industry shift in validation practices is happening, as Life Sciences clients’ successfully embrace a ‘risk-based Computer Systems Validation (CSV) approach

It is an ongoing process that requires vigilance, collaboration, and a commitment to upholding the highest standards of quality and safety.

Risk-based computerized tools provide a systematic approach to validation and compliance. These tools allow for the identification, assessment, and mitigation of risks associated with various processes and systems. 

An industry shift in validation practices is happening, as Life Sciences clients’ successfully embrace a ‘risk-based Computer Systems Assurance (CSA) approach’.

Through this shift in focus, clients have reported improved product quality and speed of delivery, as well as cost and time savings.

By implementing risk-based computerized tools, organizations can prioritize their validation efforts based on the level of risk posed by different systems or processes. This ensures that the most critical areas receive the necessary attention, saving time and resources. 

When talking about risk-based computerized tools for validation, it is important that validation and regulatory compliance professionals as well as executive management appreciates that in fully adopting the approach, they must refine the processes, practices and services that already exist in some form.

Adopting a risk-based approach provides companies with continuous improvement and maximizes system efficiency, it allows companies to constantly scale and add new features.

It’s important to note that the selection and implementation of these tools should align with the organization’s specific needs, regulatory requirements, and risk management strategies. Additionally, organizations should regularly review and update their validation tools and processes to stay current with industry best practices and changing regulations.

Recent guidance and initiatives released by the FDA, including Process Validation: General Principles and Practices and ICH Q11 Development and Manufacture of Drug Substances, have provided a streamlined, risk-based approach using an updated life cycle management method.

Under this scenario, a new definition of validation has emerged, best described by the FDA as “the collection and evaluation of data, from the process design stage through production, which establishes scientific evidence that a process is capable of consistently delivering quality products

 Critical Thinking and Risk-Based Tools Best Practices: 

• GAMP (Good Automated Manufacturing Practice): GAMP provides guidelines and best practices for validating and maintaining computerized systems used in regulated industries.
• 21 CFR Part 11: Regulatory requirements for electronic records and electronic signatures, particularly relevant to pharmaceutical and biotech companies operating in the US.
• ICH Q9 Guidelines: The International Council for Harmonisation (ICH) Q9 guideline outlines principles and methods for quality risk management in pharmaceuticals, providing a structured framework for identifying, assessing, and mitigating risks.
• ISO 14971: This standard focuses on the application of risk management to medical devices and provides guidance on identifying hazards, estimating risks, and implementing controls to mitigate those risks.

These new guidelines are in contrast to the classical definition as perhaps best emphasized in the device regulations under 21 CFR 820.75.

“Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures.”

What this means is that Critical Thinking and Risk-based tools associated with a life cycle management approach with relevant scientific rationale and evidence can be used in lieu of a traditional top-down comprehensive approach.