OOT and OOS investigations are an important aspect of clinical development and testing, and it requires visibility into the documentation, follow-up action, investigation processes, and regulatory submissions. It additionally ensures that the product is not driven into the marketplace before the investigations are finished and corrective action is taken.
Since collaboration is the key, you should keep everyone informed, assign tasks and follow up to ensure that the required action has been taken. Laboratory investigations also can be time-consuming and absence the consistency or completeness needed to meet regulatory necessities.
The process of finding Out of Specification (OOS) and Out of Trend (OOT) through manual procedures is difficult as it involves a lot of paperwork. Initially, a QA will conduct the test and manually note it down. Once the reviewer receives the test result, he goes through all the steps again to suggest the next step. An investigation might be raised to find the reason for OOS or OOT. After receiving the final sample for investigation purposes, the analyst must also repeat all the testing steps and note down everything manually. Thus, a lot of scope for transcriptional errors and compliance issues occur.
In many companies, the production group sends a batch of raw materials or completed items for production or sale even earlier than finishing the research for an OOS or OOT. This can lead to serious issues when an auditor requests all OOS or OOT investigation documents. The auditor can question the reason for taking the next step without complying with the FDA regulations.
