This article will highlight some of the steps you can take to implement lessons learned and optimize your company’s policies and procedures in terms of compliance and alignment with the regulations.
Different regulatory agencies perform frequent inspections to ensure compliance with pertinent study-related processes and their respective regulations. Learning lessons from these regulatory inspections and implementing them as part of your processes or Quality Management System will tremendously help you in the future.
Implementing the lessons learned from regulatory inspections
Immediately after an inspection, there should be a process in place for implementing lessons learned. Here are the steps to implement lessons learned from regulatory inspections:
1.Identify Lessons Learned
Identifying comments and recommendations made during recent regulatory inspections is valuable for future inspections. You also need to prepare for and conduct a Lessons Learned session.
- Prepare for lessons learned session – the preparation should be done in advance, where you organize areas that prevent discrepancies and missing information. You should have standard criteria for each clinical study you are conducting.
- Lessons Learned Session – this step focuses on identifying the successes and failures of your processes as it relates to your trials, which also includes some recommendations on how to improve performance for future regulatory inspections.
Ask the following questions:
- What went right during the inspection?
- What went wrong during the inspection?
- How can we improve for future inspections?
2. Document Lessons Learned
After capturing lessons learned, you should document everything into a comprehensive report that summarizes the inspection and what everyone can do to improve in the future. You can also conduct interviews with your team members to discuss what went right and what went wrong. Finally, you can share the report with your team members and executive team emphasizing how this will help you improve performance and readiness for future inspections.
3. Analyze Lessons Learned
Analyzing and organizing the lessons learned from regulatory inspections is also a key step to improve your preparedness in the future. You can continue to conduct meetings to assess when training will be implemented based on new or updated processes.
4. Archive Lessons Learned
Once you have finished the steps listed above, you need to organize and file the lessons learned documentation along with other reports from prior audits and /or regulatory inspections. While everyone should have access to the documents in your facility, you need to place some focus on keyword research since it will help you get access to the wanted lesson.
5. Retrieve lessons learned
The final step of the Lessons Learned process, especially as new trials arise, is to retrieve the documentation and reflect on successes and failures. Focus on how your team can maximize successes and minimize and failures in preparation for the next trial. Having a collection of lessons learned documents is a great asset that serves as powerful inspection readiness tools and allows you and your team to prepare for upcoming clinical trials in addition to future inspections in the most effective way possible.
Preparing yourself and your team before an inspection is vital to ensure that everything goes smoothly. Learning from previous lessons and implementing your new knowledge is indispensable to achieve the goal of continuous improvement and successful inspections.
If you have any questions or concerns, please do not hesitate to share your thoughts in the comment section below.