Authors: Karin Bechberger and Julia Ahlhelm
With an increasing amount of data and new technologies, there is a need to differentiate between wasting time and putting effort into non-value-added activities instead of ensuring fitness for the intended use of a computerized system. It is for this reason that the concept of critical thinking was added as an attachment to the 2nd edition of GAMP 5 Good Practice Guide: A Risk-Based Approach to Compliant GxP Computerized Systems, to enhance risk management in computer system validation.
In fact, critical thinking should be applied in a holistic manner to all business processes that support the implementation, operation, and maintenance of computerized systems. Following GAMP 5 guidance, critical thinking should be used in the proactive optimization of system planning, Quality Risk Management, and testing to ensure the compliance of computerized systems.
Prerequisites for critical thinking and when to use the approach during daily operations
The Foundation for Critical Thinking defines critical thinking as the “intellectually disciplined process of actively and skillfully conceptualizing, applying, analyzing, synthesizing, and/or evaluating information gathered from, or generated by, observation, experience, reflection, reasoning, or communication, as a guide to belief and action.” GxP compliance manager Charlie Wakeman simplifies that in an ISPE blog by explaining critical thinking as “focusing on what matters.” By prioritizing quality over compliance and documentation, actions taken with a focus on improving quality naturally lead to compliance.
To encourage employees within a life science organization to apply critical thinking in their daily work, organizations must grant permission within the Quality Management System and validation policy. This can be done using templates or by providing format options that cover essential elements and their activities.
GAMP 5 guidance encourages organizations to focus validation efforts on the most critical functions of the software application. This begins with its application during the planning phase. Using process mapping and diagramming tools can help identify and understand implementation risks. For example, a critical thinking approach can verify that there is a full understanding of how data flows to ensure data integrity in all process steps.
Defining specific requirements is a key task for the implementation of computerized system functionalities. Critical thinking can ensure that requirements related to regulatory compliance fit the system´s intended use. One example of applying critical thinking during the requirement specification is defining the need for an audit trail for GxP-regulated records.
For the use of software “as a Service” solutions, GAMP 5 recommends a supplier assessment with a focus on long-term provision and stability. By using critical thinking, organizations can determine that their supplier´s services fit the regulated company’s intended use. This in turn can help companies ascertain that the service provider adopts appropriate controls and maintains required records within their Quality Risk Management.
When it comes to managing data, multiple systems can be involved in a single data lifecycle, from generation through data processing to archiving. Critical thinking should be applied to consider how best to manage this interplay between computerized systems and the data life cycle.
Testing is fundamental for verifying that a system is working as expected, as this is needed to identify and correct possible deficiencies. The application of critical thinking can facilitate and optimize the test approaches. And, with thoughtful planning and organization of these tests, they can be combined or grouped into related functional tests to increase your team’s efficiency.
Computerized systems should constantly be tested, reviewed, and developed to improve patient safety, product quality, and data integrity. Faced with the associated validation and documentation burden, the application of critical thinking provides a structured and efficient approach for all regulated organizations. This avoids using outdated or unsupported operating systems and the associated security risks.
Without critical thinking, there is a risk of excessive work and insufficiency with the potential to blow the calculated budget and time delays. Successful implementation and application are therefore essential for pharmaceutical companies to remain competitive. However, this often depends on the mentality of the organization and its ability to build and maintain a company-wide critical thinking culture and understanding. With our extensive experience in the regulatory environment, GxP-CC lives these values and applies its critical thinking skills to every engagement. Contact us today to learn how we can support YOU and move forward together.