Requirements for Knowledge Management

I was recently reviewing the updated Q9(R1) Annex 1- Q8/Q9/Q10 Questions & Answers (R5) related to ICH Q9(R1) Quality Risk Management (QRM) that were approved on 30 October 2024 and what they say about knowledge management. While there are some fun new questions asked, I particularly like “Do regulatory agencies expect to see a formal knowledge management approach during inspections?”

To which the answer was: “No. There is no regulatory requirement for a formal knowledge management system. However. it is expected that knowledge from different processes and
systems is appropriately utilised. Note: ‘formal’ in this context means a structured approach using a recognised methodology or (IT-) tool, executing and documenting something in a transparent and detailed manner.”

What does appropriately utilized mean? What is the standard for determining it? The agencies are quite willing to leave that to you to figure out.

As usual I think it is valuable to agree upon a few core assumptions for what appropriate utilization of knowledge management might look like.

Accessibility and Sharing

Knowledge should be easily accessible to those who need it within the organization. This means:

• Implementing centralized knowledge repositories or databases
• Ensuring information is structured and organized for easy retrieval
• Fostering a culture of knowledge sharing among employees

Relevance and Accuracy

Appropriately utilized knowledge is:

• Up-to-date and accurate
• Relevant to the specific needs of the organization and its employees
• Regularly reviewed and updated to maintain its value

Integration into Processes

Knowledge should be integrated into the organization’s workflows and decision-making processes:

• Incorporated into standard operating procedures
• Used to inform strategic planning and problem-solving
• Applied to improve efficiency and productivity

Measurable Impact

Appropriate utilization of knowledge should result in tangible benefits:

• Improved decision-making
• Increased productivity and efficiency
• Enhanced innovation and problem-solving capabilities
• Reduced duplication of efforts

Continuous Improvement

Appropriate utilization of knowledge includes a commitment to ongoing improvement:

• Regular assessment of knowledge management processes
• Gathering feedback from users
• Adapting strategies based on changing organizational needs